Trial Outcomes & Findings for Needling Techniques for Knee Osteoarthritis (NCT NCT05014542)

NCT ID: NCT05014542

Last Updated: 2025-07-29

Results Overview

The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: Week 15
• Results posted on: 2025-07-29

Participant Flow

The recruitment process was carried out from January 2021 to August 2021. The recruitment was performed at the Family Medicine practice, run by the investigator, who has access to the database of four thousand patients from two practices. From the 4000 patients, 180 made the target population by criteria ≥50 years and confirmed KOA from a computer database. A study population of 64 participants was made by applying the inclusion and exclusion criteria.

In the pre-assignment period, all 64 enrolled participants were assigned in a concealed manner to the A or C group.

Participant milestones

Measure	Acupuncture Group 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to analgesics, whose dose could vary according to the participant's need. Participants and investigators were not blinded by treatment type, but assessors were blinded about the fact to which group participants belonged. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete treatment lasted 30 minutes. Conventional Medical Treatment: Participants took analgesics, prescribed by their general practitioner. They could modify the analgesics' dose according to the intensity of their symptoms.	Control Group 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Week 1-24, Between Group Analysis STARTED	32	32
Week 1-24, Between Group Analysis End of Acupuncture Treatments Treatment of A Group	25	30
Week 1-24, Between Group Analysis 9 Weeks After Completing the Acupuncture Treatment	25	29
Week 1-24, Between Group Analysis COMPLETED	25	29
Week 1-24, Between Group Analysis NOT COMPLETED	7	3
Week 25-39, Within Group Analysis STARTED	25	29
Week 25-39, Within Group Analysis COMPLETED	23	23
Week 25-39, Within Group Analysis NOT COMPLETED	2	6

Reasons for withdrawal

Measure	Acupuncture Group 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to analgesics, whose dose could vary according to the participant's need. Participants and investigators were not blinded by treatment type, but assessors were blinded about the fact to which group participants belonged. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete treatment lasted 30 minutes. Conventional Medical Treatment: Participants took analgesics, prescribed by their general practitioner. They could modify the analgesics' dose according to the intensity of their symptoms.	Control Group 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Week 1-24, Between Group Analysis Withdrawal by Subject	6	3
Week 1-24, Between Group Analysis Lost to Follow-up	1	0
Week 25-39, Within Group Analysis Withdrawal by Subject	0	5
Week 25-39, Within Group Analysis Lost to Follow-up	2	1

Baseline Characteristics

Some participants did not respond to the measurement.

Baseline characteristics by cohort

Measure	Acupuncture Group n=32 Participants Participants in the Acupuncture (A) group got acupuncture treatments for their knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with a frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) whose dose varied according to participant symptoms intensity. The participants and investigator were not blinded by treatment type. The assessors were blinded for the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles were manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	Control Group n=32 Participants Participants in the Control (C) group got their standard conventional treatment (analgesics) whose dose could vary according to the participants' symptoms intensity. Participants and investigator were not blinded for treatment type. The assessors were blinded for the fact to which group participants belong. Conventional Medical Treatment: Participants took their standard conventional medical treatment or analgesics. Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	Total n=64 Participants Total of all reporting groups
Kellgren-Lawrence (K-L) grade, Categorical grade 3	19 Participants n=32 Participants	13 Participants n=32 Participants	32 Participants n=64 Participants
Kellgren-Lawrence (K-L) grade, Categorical grade 4	6 Participants n=32 Participants	10 Participants n=32 Participants	16 Participants n=64 Participants
WOMAC total, Continuous	56.4 score on a scale STANDARD_DEVIATION 18.908 • n=32 Participants	57.3 score on a scale STANDARD_DEVIATION 20.20 • n=32 Participants	56.9 score on a scale STANDARD_DEVIATION 19.414 • n=64 Participants
WOMAC pain, Continuous	11.5 score on a scale STANDARD_DEVIATION 4.607 • n=32 Participants	11.7 score on a scale STANDARD_DEVIATION 4.37 • n=32 Participants	11.6 score on a scale STANDARD_DEVIATION 4.457 • n=64 Participants
WOMAC stiffness, Continuous	3.8 score on a scale STANDARD_DEVIATION 1.505 • n=32 Participants	4.2 score on a scale STANDARD_DEVIATION 2.20 • n=32 Participants	4.0 score on a scale STANDARD_DEVIATION 1.877 • n=64 Participants
WOMAC functional disability, Continuous	40.8 score on a scale STANDARD_DEVIATION 14.123 • n=32 Participants	41.9 score on a scale STANDARD_DEVIATION 14.88 • n=32 Participants	41.5 score on a scale STANDARD_DEVIATION 14.292 • n=64 Participants
VAS, Continuous	59.5 score on a scale STANDARD_DEVIATION 22.767 • n=32 Participants	59.1 score on a scale STANDARD_DEVIATION 18.11 • n=32 Participants	59.3 score on a scale STANDARD_DEVIATION 20.41 • n=64 Participants
Age, Continuous	64.1 years STANDARD_DEVIATION 7.94 • n=32 Participants	64.7 years STANDARD_DEVIATION 8.27 • n=32 Participants	64.4 years STANDARD_DEVIATION 8.05 • n=64 Participants
Sex: Female, Male Female	25 Participants n=32 Participants	24 Participants n=32 Participants	49 Participants n=64 Participants
Sex: Female, Male Male	7 Participants n=32 Participants	8 Participants n=32 Participants	15 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Race (NIH/OMB) White	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants
Race (NIH/OMB) More than one race	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=64 Participants
Body Mass Index (BMI), Continuous	31.4 kg/m2 STANDARD_DEVIATION 5.45 • n=32 Participants	30.6 kg/m2 STANDARD_DEVIATION 5.70 • n=32 Participants	31.0 kg/m2 STANDARD_DEVIATION 5.55 • n=64 Participants
Kellgren-Lawrence (K-L) grade, Categorical grade 2	7 Participants n=32 Participants	9 Participants n=32 Participants	16 Participants n=64 Participants
Active flexion L and R knees, Continuous Active flexion R knee	93.448 degree of angle STANDARD_DEVIATION 16.802 • n=29 Participants • Some participants did not respond to the measurement.	88.666 degree of angle STANDARD_DEVIATION 21.573 • n=30 Participants • Some participants did not respond to the measurement.	91.02 degree of angle STANDARD_DEVIATION 19.360 • n=59 Participants • Some participants did not respond to the measurement.
Active extension L and R knee, Continuous Active extension L knee	0.586 degree of angle STANDARD_DEVIATION 1.783 • n=29 Participants • Some participants did not respond to the measurement.	0.5 degree of angle STANDARD_DEVIATION 1.526 • n=30 Participants • Some participants did not respond to the measurement.	0.54 degree of angle STANDARD_DEVIATION 1.643 • n=59 Participants • Some participants did not respond to the measurement.
Active extension L and R knee, Continuous Active extension R knee	0.759 degree of angle STANDARD_DEVIATION 2.370 • n=29 Participants • Some participants did not respond to the measurement.	0.5 degree of angle STANDARD_DEVIATION 1.526 • n=30 Participants • Some participants did not respond to the measurement.	0.63 degree of angle STANDARD_DEVIATION 1.973 • n=59 Participants • Some participants did not respond to the measurement.
KDSQ, Continuous	27.2 score on a scale STANDARD_DEVIATION 11.105 • n=32 Participants	26.2 score on a scale STANDARD_DEVIATION 11.89 • n=32 Participants	26.7 score on a scale STANDARD_DEVIATION 11.427 • n=64 Participants
DRUG /IBU, Continuous	637.5 milligram-equivalent of ibuprofen STANDARD_DEVIATION 1095.960 • n=32 Participants	625 milligram-equivalent of ibuprofen STANDARD_DEVIATION 841.66 • n=32 Participants	631.3 milligram-equivalent of ibuprofen STANDARD_DEVIATION 969.352 • n=64 Participants
Active flexion L and R knees, Continuous Active flexion L knee	95.103 degree of angle STANDARD_DEVIATION 17.707 • n=29 Participants • Some participants did not respond to the measurement.	89.167 degree of angle STANDARD_DEVIATION 23.159 • n=30 Participants • Some participants did not respond to the measurement.	92.08 degree of angle STANDARD_DEVIATION 20.70 • n=59 Participants • Some participants did not respond to the measurement.
Circumference of L and R upper leg, Continuous Circumference of L upper leg	57.931 centimeter STANDARD_DEVIATION 5.941 • n=29 Participants • Some participants did not respond to the measurement.	55.607 centimeter STANDARD_DEVIATION 5.755 • n=30 Participants • Some participants did not respond to the measurement.	56.75 centimeter STANDARD_DEVIATION 5.914 • n=59 Participants • Some participants did not respond to the measurement.
Circumference of L and R upper leg, Continuous Circumference of R upper leg	58.121 centimeter STANDARD_DEVIATION 5.648 • n=29 Participants • Some participants did not respond to the measurement.	56.26 centimeter STANDARD_DEVIATION 5.613 • n=30 Participants • Some participants did not respond to the measurement.	57.17 centimeter STANDARD_DEVIATION 5.660 • n=59 Participants • Some participants did not respond to the measurement.
Circumference of L and R knee, Continuous Circumference of L knee	42.610 centimeter STANDARD_DEVIATION 4.26 • n=29 Participants • Some participants did not respond to the measurement.	41.973 centimeter STANDARD_DEVIATION 3.279 • n=30 Participants • Some participants did not respond to the measurement.	42.29 centimeter STANDARD_DEVIATION 3.773 • n=59 Participants • Some participants did not respond to the measurement.
Circumference of L and R knee, Continuous Circumference of R knee	42.966 centimeter STANDARD_DEVIATION 4.598 • n=29 Participants • Some participants did not respond to the measurement.	42.013 centimeter STANDARD_DEVIATION 3.168 • n=30 Participants • Some participants did not respond to the measurement.	42.48 centimeter STANDARD_DEVIATION 3.931 • n=59 Participants • Some participants did not respond to the measurement.

PRIMARY outcome

Timeframe: Week 15

Population: WOMAC total in Week 15 estimates the immediate treatment effects of acupuncture on pain, stiffness and knee function when acupuncture treatments ended in a between-groups A and C analysis.

The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability.

The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Total in Week 15	11.6 score on a scale Standard Deviation 11.633	54.4 score on a scale Standard Deviation 19.4	—	—

SECONDARY outcome

Timeframe: Week 15

Population: WOMAC pain in Week 15 estimates the immediate treatment effects of acupuncture at Week 15 on knee OA pain after acupuncture treatments were completed in a between-groups A and C analysis.

Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better outcome.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Pain in Week 15	2.4 score on a scale Standard Deviation 2.4	11.3 score on a scale Standard Deviation 4.6	—	—

SECONDARY outcome

Timeframe: Week 15

Population: WOMAC stiffness in Week 15 estimates the immediate treatment effects of acupuncture on knee OA stiffness after acupuncture treatments were completed at Week 15 in a between-groups A and C analysis.

Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Stiffness in Week 15	0.7 score on a scale Standard Deviation 0.9	4.6 score on a scale Standard Deviation 1.9	—	—

SECONDARY outcome

Timeframe: Week 15

Population: WOMAC functional disability in Week 15 estimates the immediate treatment effects of acupuncture on knee OA functional disability after acupuncture treatments were completed at Week 15 in a between-groups A and C analysis.

Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Functional Disability in Week 15	8.6 score on a scale Standard Deviation 8.8	38.6 score on a scale Standard Deviation 13.9	—	—

SECONDARY outcome

Timeframe: Week 15

Population: VAS 15 measure estimates the treatment effect of acupuncture on KOA pain at the acupuncture treatment completion time point, analysed between the A and C groups.

Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
VAS in Week 15	12.6 score on a scale Standard Deviation 12	61 score on a scale Standard Deviation 19.5	—	—

SECONDARY outcome

Timeframe: Week 15

Population: KDSQ in Week 15 estimates the treatment effect of acupuncture on Kidney deficiency symptoms at the end of the acupuncture treatments, analysed between the A and C groups.

The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency (KD) symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome.

This measure represents the effect of acupuncture treatment on KD.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
KDSQ in Week 15	10.8 score on a scale Standard Deviation 6.7	24.8 score on a scale Standard Deviation 12.5	—	—

SECONDARY outcome

Timeframe: Week 15

Population: DRUG in Week 15 estimates the treatment effect of acupuncture on knee OA pain at the end of acupuncture treatment, analysed between groups A and C.

DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=30 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
DRUG in Week 15	96.0 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 183.7	870.0 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 950.2	—	—

SECONDARY outcome

Timeframe: Week 15

Population: Active extension of L and R knees in Week 15 represents the treatment effect of acupuncture on the knee OA at the completed acupuncture treatment time point in Week 15, compared between groups A and C.

The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units.

Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes.

Outcome measures

Measure	A Group in Week 15 n=28 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Active Extension L and R Knees in Week 15 L knee active extension	0.429 degrees of a goniometer angle Standard Deviation 1.6	0.42 degrees of a goniometer angle Standard Deviation 1.35	—	—
Active Extension L and R Knees in Week 15 R knee active extension	0.607 degrees of a goniometer angle Standard Deviation 2.27	0.714 degrees of a goniometer angle Standard Deviation 1.78	—	—

SECONDARY outcome

Timeframe: Week 15

Population: Active flexion of L and R knees in Week 15 represents the treatment effect of acupuncture on knee function at the end of acupuncture treatment, Week 15, between groups A and C at Week 15.

Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units).

Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one.

Outcome measures

Measure	A Group in Week 15 n=28 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Active Flexion L and R Knees in Week 15 L knee active flexion	94.1 degrees on a goniometer angle Standard Deviation 17.1	90.2 degrees on a goniometer angle Standard Deviation 18.9	—	—
Active Flexion L and R Knees in Week 15 R knee active flexion	96.1 degrees on a goniometer angle Standard Deviation 17.3	91.4 degrees on a goniometer angle Standard Deviation 18.6	—	—

SECONDARY outcome

Timeframe: Week15

Population: This measure estimates the treatment effect of acupuncture on knee function at the end of the acupuncture treatment time point in Week 15, in the between-groups A and C analysis.

Circumference of the left (L) and right (R) upper leg in Week 15 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.

Outcome measures

Measure	A Group in Week 15 n=28 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Circumference of L and R Upper Leg in Week 15 L upper leg circumference	55.3 centimeters Standard Deviation 5.84	58.3 centimeters Standard Deviation 5.87	—	—
Circumference of L and R Upper Leg in Week 15 R upper leg circumference	58.7 centimeters Standard Deviation 6.88	55.7 centimeters Standard Deviation 9.25	—	—

SECONDARY outcome

Timeframe: Week 15

Population: Circumference of L and R knees in Week 15 estimates the treatment effect of acupuncture on knee osteoarthritis at the end of the acupuncture treatment time point, analysed between groups A and C.

Circumference of left (L) and right (R) knees at Week 15 is an objective measurement taken by an independent physiatrist; the measure includes the difference in circumference of the knees measured with a tape measure at the middle of the patellae. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents knee inflammation and joint deformation (abnormal bone growth). Increased values indicate worse outcomes from a higher level of knee inflammation/deformation, and decreased values indicate better outcomes from a lower level of knee inflammation/deformation.

Outcome measures

Measure	A Group in Week 15 n=28 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Circumference of L and R Knees in Week 15 L knee circumference	43.1 centimeters Standard Deviation 3.9	41.8 centimeters Standard Deviation 3.23	—	—
Circumference of L and R Knees in Week 15 R knee circumference	43.1 centimeters Standard Deviation 4.14	41.8 centimeters Standard Deviation 3.0	—	—

SECONDARY outcome

Timeframe: Week 24

Population: WOMAC total in Week 24 represents the treatment effect of acupuncture on pain, stiffness, and function at Assessment 9, in Week 24, nine weeks after acupuncture treatment ended, and was analysed between groups A and C.

Western Ontario and McMaster University Osteoarthritis (WOMAC) index's total score is a sum of all three subscales for pain, stiffness, and functional disability, the minimum value is 0, and the maximum value is 96; the lower score/value represents a better outcome, and a higher score/value represents a worse outcome

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Total in Week 24	20.4 score on a scale Standard Deviation 18.4	53.4 score on a scale Standard Deviation 20.5	—	—

SECONDARY outcome

Timeframe: Week 24

Population: WOMAC pain in Week 24, nine weeks after acupuncture treatment ended, was analysed between groups A and C.

Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Pain in Week 24	4.5 score on a scale Standard Deviation 3.7	11 score on a scale Standard Deviation 4.6	—	—

SECONDARY outcome

Timeframe: Week 24

Population: WOMAC stiffness in Week 24, nine weeks after acupuncture treatment ended, was analysed between groups A and C.

Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Stiffness in Week 24	1.1 score on a scale Standard Deviation 1.5	3.4 score on a scale Standard Deviation 2.2	—	—

SECONDARY outcome

Timeframe: Week 24

Population: WOMAC functional disability in Week 24 estimates the effects of acupuncture on functional disability nine weeks after the acupuncture treatment of knee OA ended, using a between-groups A and C analysis.

Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items of functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting, and difficulties in domestic duties.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Functional Disability in Week 24	14.7 score on a scale Standard Deviation 13.7	39.0 score on a scale Standard Deviation 14.5	—	—

SECONDARY outcome

Timeframe: Week 24

Population: VAS in Week 24 estimates the treatment effect of acupuncture on knee pain, 9 weeks after acupuncture treatment ended, in between groups.

Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
VAS in Week 24	13.8 score on a scale Standard Deviation 13.9	59.5 score on a scale Standard Deviation 23.9	—	—

SECONDARY outcome

Timeframe: Week 24

Population: KDSQ in Week 24 estimates the treatment effect of acupuncture on KD symptoms 9 weeks after acupuncture treatment ended, analysed between groups.

The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome.

This measure represents the effect of acupuncture treatment on Kidney deficiency (KD).

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
KDSQ in Week 24	13.9 score on a scale Standard Deviation 8.9	25.0 score on a scale Standard Deviation 12.4	—	—

SECONDARY outcome

Timeframe: Week 24

Population: DRUG in Week 24 estimates the treatment effect of acupuncture on knee OA pain nine weeks after the end of acupuncture treatment, analysed between groups A and C.

DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
DRUG in Week 24	184.0 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 395	765.5 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 783	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Active extension of L and R knee in Week 24 represents the treatment effect of acupuncture on the knee OA, nine weeks after the acupuncture treatment ended, compared between groups A and C.

The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units.

Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes.

Outcome measures

Measure	A Group in Week 15 n=22 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=28 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Active Extension L and R Knee in Week 24 Active extension of L knee at Week 24	0 degrees of a goniometer angle Standard Deviation 0	0 degrees of a goniometer angle Standard Deviation 0	—	—
Active Extension L and R Knee in Week 24 Active extension of R knee at Week 24	0 degrees of a goniometer angle Standard Deviation 0	0 degrees of a goniometer angle Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Active flexion of L and R knees in Week 24 represents the treatment effect of acupuncture on knee function nine weeks after acupuncture treatment ended, compared between groups.

Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units).

Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one.

Outcome measures

Measure	A Group in Week 15 n=22 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=28 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Active Flexion L and R Knees in Week 24 L knee	98.6 degrees of a goniometer angle Standard Deviation 16.4	99.5 degrees of a goniometer angle Standard Deviation 24.8	—	—
Active Flexion L and R Knees in Week 24 R knee	101.6 degrees of a goniometer angle Standard Deviation 22.1	99.8 degrees of a goniometer angle Standard Deviation 21.5	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Circumference of L and R upper leg in Week 24 estimates the treatment effect of acupuncture on knee OA, nine weeks after the acupuncture treatment ended, analysed between groups.

Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.

Outcome measures

Measure	A Group in Week 15 n=22 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=28 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Circumference of L and R Upper Leg in Week 24 Circumference of L Upper Leg at Week 24	58.8 centimeters Standard Deviation 5.59	57.2 centimeters Standard Deviation 6.61	—	—
Circumference of L and R Upper Leg in Week 24 Circumference of R Upper Leg at Week 24	59.3 centimeters Standard Deviation 5.93	57.2 centimeters Standard Deviation 6.83	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Circumference of L and R Knee in Week 24 estimates the direct treatment effect of acupuncture on knee osteoarthritis, nine weeks after acupuncture treatment ended, analysed between groups.

Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.

Outcome measures

Measure	A Group in Week 15 n=22 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=28 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Circumference of L and R Knee in Week 24 Circumference of L knees at Week 24 in between-groups	43.6 centimeters Standard Deviation 4.62	42.4 centimeters Standard Deviation 4.14	—	—
Circumference of L and R Knee in Week 24 Circumference of R knees at Week 24 in between-groups	44.0 centimeters Standard Deviation 4.38	42.4 centimeters Standard Deviation 4.08	—	—

SECONDARY outcome

Timeframe: Week 39

Population: WOMAC total in Week 39 represents the treatment effect of acupuncture on knee pain, stiffness, and function at the added assessment in Week 39 in the A and C groups compared to their baseline values by within-group analysis. It presents two: the magnitude of persisted effects 24 weeks after acupuncture treatment ended in group A, and the immediate effects of acupuncture treatment in group C in comparison with their baseline values.

Western Ontario and McMaster University Osteoarthritis (WOMAC) total at the Added assessment at Week 39 in the crossover part compared to pre-experimental baseline value. The total score is a sum of all three subscales: pain, stiffness, and functional limitation. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and a higher score/value represents a worse outcome.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Total in Week 39	22.0 score on a scale Standard Deviation 20.7	18.2 score on a scale Standard Deviation 17.62	56.4 score on a scale Standard Deviation 18.91	57.3 score on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: Week 39

Population: WOMAC pain subscale in Week 39 by within-group analysis presented the magnitude of persisted pain reduction in group A (24 weeks after acupuncture treatment ended), and in group C, the immediate effects, when group C received acupuncture treatments after crossover in Week 25.

The Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, selected from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Pain in Week 39	5.3 score on a scale Standard Deviation 4.72	4.7 score on a scale Standard Deviation 3.77	11.5 score on a scale Standard Deviation 4.61	11.7 score on a scale Standard Deviation 4.37

SECONDARY outcome

Timeframe: Week 39

Population: WOMAC stiffness in Week 39 presents in group A the magnitude of persisted acupuncture effects 24 weeks after acupuncture treatment ended, and in group C, the immediate effects of acupuncture after group C crossed over in Week 25, analysed within-groups.

Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Stiffness in Week 39	1.2 score on a scale Standard Deviation 2.17	1.2 score on a scale Standard Deviation 1.95	3.8 score on a scale Standard Deviation 1.51	4.2 score on a scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: Week 39

Population: WOMAC functional disability in Week 39 represents the treatment effect of acupuncture on knee functional disability at the added assessment in Week 39 in the A and C groups compared to their baseline values by within-group analysis. It presents two: the magnitude of persisted effects 24 weeks after acupuncture treatment ended in group A, and the immediate effects of acupuncture treatment in group C in comparison with their baseline values.

Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
WOMAC Functional Disability in Week 39	15.5 score on a scale Standard Deviation 14.3	12.3 score on a scale Standard Deviation 12.83	40.8 score on a scale Standard Deviation 14.12	41.9 score on a scale Standard Deviation 14.88

SECONDARY outcome

Timeframe: Week 39

Population: VAS in Week 39 presented two: group A was analysed for the magnitude of the persisted acupuncture effects 24 weeks after acupuncture ended, and the immediate acupuncture effect on knee pain was presented in group C.

Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome.

This measure estimates the treatment effect of acupuncture on knee pain in Week 39 separately for groups A and C.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
VAS in Week 39	18.3 score on a scale Standard Deviation 22.59	28.0 score on a scale Standard Deviation 21.36	59.5 score on a scale Standard Deviation 22.77	59.1 score on a scale Standard Deviation 18.1

SECONDARY outcome

Timeframe: Week 39

Population: KDSQ in Week 39 represents the treatment effect of acupuncture on Kidney deficiency symptoms intensity at the completed acupuncture treatments time point in group C and the magnitude of persisted effects 24 weeks after acupuncture treatments ended in group A, compared with Week 0 by within-group analysis separately for both groups.

The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome.

This outcome represents the treatment effect of acupuncture on Kidney deficiency symptoms for both groups separately.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
KDSQ in Week 39	14.6 score on a scale Standard Deviation 9.12	14.8 score on a scale Standard Deviation 8.92	27.2 score on a scale Standard Deviation 11.10	26.2 score on a scale Standard Deviation 11.89

SECONDARY outcome

Timeframe: Week 39

Population: DRUG in Week 39 estimates the treatment effect of acupuncture on knee OA pain at the end of acupuncture treatment, analysed within groups A and C to present the effects of the 24-week period after acupuncture ended in group A, and the immediate effects in group C.

DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain.

Outcome measures

Measure	A Group in Week 15 n=23 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=23 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 n=32 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 n=32 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
DRUG by Added Assessment in Week 39, Crossover Part	276.1 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 566.46	319.6 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 473.08	637.5 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 1095.96	625.0 milligrams-equivalent of ibuprofen(IBU) Standard Deviation 841.66

SECONDARY outcome

Timeframe: Week 24

Population: Groups A and C were compared in Week 24 using a between-groups analysis to assess the effect of the acupuncture treatment on Group A, as Group C served as the control up to Week 24.

The Lequesne index is an algofunctional index of knee osteoarthritis that comprises three sections. Its score ranges from a minimal 0 (no pain and disability) to 24 (the greatest pain and disability). This index is added to the study in Week 24 as an additional objective measure. It measures pain severity with 5 questions, walking distance with 2 questions, and activities of daily living with 4 questions.

Outcome measures

Measure	A Group in Week 15 n=25 Participants 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 15 n=29 Participants 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.	A Group in Week 0 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	C Group in Week 0 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Lequesne Index in Week 24, Between-group Analysis	5.1 score on a scale Standard Deviation 3.45	12.63 score on a scale Standard Deviation 5.06	—	—

Adverse Events

Acupuncture Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acupuncture Group n=32 participants at risk 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms.	Control Group n=32 participants at risk 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms.
Injury, poisoning and procedural complications suprapatellar knee jount effusion (M13.1)	3.1% 1/32 • Number of events 1 • The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm. Every participant had his own form for adverse events where the observer fulfilled adverse events.	0.00% 0/32 • The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm. Every participant had his own form for adverse events where the observer fulfilled adverse events.
Injury, poisoning and procedural complications hematoma subcutaneus	3.1% 1/32 • Number of events 1 • The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm. Every participant had his own form for adverse events where the observer fulfilled adverse events.	0.00% 0/32 • The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm. Every participant had his own form for adverse events where the observer fulfilled adverse events.
Injury, poisoning and procedural complications hematoma of upper leg	0.00% 0/32 • The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm. Every participant had his own form for adverse events where the observer fulfilled adverse events.	3.1% 1/32 • Number of events 1 • The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm. Every participant had his own form for adverse events where the observer fulfilled adverse events.

Additional Information

Svijetlana Perculija Durdevic, MD, family medicine specialist, acupuncturist

Family Medicine Practice Svijetlana Perculija Durdevic, MD, Ninska 10, Sesvete

Phone: 00385913302507

Email: svijetlana.perculija.durdevic@outlook.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place