Trial Outcomes & Findings for Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis (NCT NCT04168593)

Results Overview

Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

value collected at 5 week

Results posted on

2025-03-27

Participant Flow

recruitment by phone from a list of patients with advanced KOA who is waiting for a TKR. the inclusion criteria is applied.

by phone we applied the WOMAC-Pain and invite who have 15 points or more

Participant milestones

Participant milestones
Measure	A- Acupuncture Sham + Cupping Sham Sham acupuncture: Placement of placebo "dagger" needles. The needle tip, when touching the patient's skin, retracts into itself without puncturing the skin. Application locations: LI11, SP9, SP10, LR8, GB34, ST34, Ex-LE5. Running time of 20 minutes. Sham cupping: after each acupuncture session (Sham or True), the respective needles were removed, and acrylic suction cups were placed over the region where the needles were, attached to a strip (micropore) without exerting any negative pressure or movement. Application time of 10 minutes.	B -Sham Acupuncture + Real Cupping Acupuncture 20 min of Acupuncture section follow by 10 min of cupping around the knee	C - Real Acupuncture + Sham Cupping 20 min of Acupuncture section follow by 10 min of cupping around the knee	D - Real Acupuncture + Real Cupping 20 min of Acupuncture section follow by 10 min of cupping around the knee
Overall Study STARTED	30	30	30	30
Overall Study COMPLETED	26	28	27	29
Overall Study NOT COMPLETED	4	2	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A- Placebo n=30 Participants Sham Acupuncture and Sham Cupping 20 min of Acupuncture section using placebo needle follow by 10 min of cupping sham (no negative pressure) around the knee	B -Cupping n=30 Participants Sham Acupuncture and Real Cupping 20 min of Acupuncture section using placebo needle follow by 10 min of real cupping around the knee	C - Acupuncture n=30 Participants Real Acupuncture and Sham Cupping 20 min of Real Acupuncture section follow by 10 min of sham cupping around the knee	D - Acupuncture + Cupping n=30 Participants Real Acupuncture and Real Cupping 20 min of Real Acupuncture section follow by 10 min of real cupping around the knee	Total n=120 Participants Total of all reporting groups
Age, Customized Age distribution	66.1 years STANDARD_DEVIATION 10.88 • n=30 Participants	66.1 years STANDARD_DEVIATION 10.86 • n=30 Participants	68.1 years STANDARD_DEVIATION 11.15 • n=30 Participants	66.8 years STANDARD_DEVIATION 8.09 • n=30 Participants	66.8 years STANDARD_DEVIATION 10.17 • n=120 Participants
Sex: Female, Male Female	21 Participants n=30 Participants	23 Participants n=30 Participants	23 Participants n=30 Participants	25 Participants n=30 Participants	92 Participants n=120 Participants
Sex: Female, Male Male	9 Participants n=30 Participants	7 Participants n=30 Participants	7 Participants n=30 Participants	5 Participants n=30 Participants	28 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Brazil	30 participants n=30 Participants	30 participants n=30 Participants	30 participants n=30 Participants	30 participants n=30 Participants	120 participants n=120 Participants
WOMAC-Pain	16.83 units on a scale STANDARD_DEVIATION 1.74 • n=30 Participants	16.50 units on a scale STANDARD_DEVIATION 1.38 • n=30 Participants	16.40 units on a scale STANDARD_DEVIATION 1.43 • n=30 Participants	16.90 units on a scale STANDARD_DEVIATION 1.75 • n=30 Participants	16.66 units on a scale STANDARD_DEVIATION 1.58 • n=120 Participants
VAS	84.03 units on a scale STANDARD_DEVIATION 13.75 • n=30 Participants	89.57 units on a scale STANDARD_DEVIATION 11.81 • n=30 Participants	82.83 units on a scale STANDARD_DEVIATION 12.97 • n=30 Participants	91.30 units on a scale STANDARD_DEVIATION 11.43 • n=30 Participants	89.92 units on a scale STANDARD_DEVIATION 12.88 • n=120 Participants

PRIMARY outcome

Timeframe: value collected at 5 week

Population: We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis

Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)

Outcome measures

Outcome measures
Measure	Group A n=30 Participants Sham Acupuncture + Sham Cupping	Group B n=30 Participants Sham Acupuncture + Real Cupping	Group C n=30 Participants Real Acupuncture + Sham Cupping	Group D n=30 Participants Real Acupuncture + Real Cupping	Group D Real Acupuncture + Real Cupping
WOMAC - Pain	11.60 units on a scale Standard Deviation 4.17	11.30 units on a scale Standard Deviation 4.23	10.80 units on a scale Standard Deviation 4.64	9.83 units on a scale Standard Deviation 4.76	—

PRIMARY outcome

Timeframe: Value collected at 5 weeks

Population: We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.

Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)

Outcome measures

Outcome measures
Measure	Group A n=30 Participants Sham Acupuncture + Sham Cupping	Group B n=30 Participants Sham Acupuncture + Real Cupping	Group C n=30 Participants Real Acupuncture + Sham Cupping	Group D n=30 Participants Real Acupuncture + Real Cupping	Group D Real Acupuncture + Real Cupping
VAS	67.43 units on a scale Standard Deviation 23.09	61.57 units on a scale Standard Deviation 25.57	47.87 units on a scale Standard Deviation 27.23	47.43 units on a scale Standard Deviation 28.99	—

SECONDARY outcome

Timeframe: Number of Participants with reduction in the use of pain medications after protocol (at 5 week)

Population: We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.

number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no).

Outcome measures

Outcome measures
Measure	Group A n=120 Participants Sham Acupuncture + Sham Cupping	Group B n=30 Participants Sham Acupuncture + Real Cupping	Group C n=30 Participants Real Acupuncture + Sham Cupping	Group D n=30 Participants Real Acupuncture + Real Cupping	Group D n=30 Participants Real Acupuncture + Real Cupping
Analgesic Consumption	72 Participants	12 Participants	18 Participants	19 Participants	23 Participants

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group D

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A n=30 participants at risk Sham + Sham	Group B n=30 participants at risk Sham Acp + Real Cupping	Group C n=30 participants at risk Real ACP + Sham Cupping	Group D n=30 participants at risk Real + Real
Skin and subcutaneous tissue disorders hematoma	0.00% 0/30 • after 5 weeks from initial treatment no serious adverse event, only local hematoma	3.3% 1/30 • after 5 weeks from initial treatment no serious adverse event, only local hematoma	6.7% 2/30 • after 5 weeks from initial treatment no serious adverse event, only local hematoma	6.7% 2/30 • after 5 weeks from initial treatment no serious adverse event, only local hematoma

Additional Information

Andre Wan Wen Tsai

USaoPauloGH

Phone: 5511981456449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place