Trial Outcomes & Findings for Physical Therapist as Primary Assessor for Patients With Knee Pain in Primary Care (NCT NCT03715764)

Last Updated: 2021-12-17

Results Overview

A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The questionnaire contain five dimensions and results in an index ranging from -0,549 to 1 using the UK tariffs. An index of 1 indicate full health.

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

12 months

Results posted on

2021-12-17

Participant Flow

Assessed for eligibility (n=363) Excluded (n=294) * Not meeting inclusion criteria (n=185) * Declined to participate (n=15) * Excluded due to exclusion criteria (n=94)

Participant milestones

Participant milestones
Measure	Physical Therapy Assessment Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
Baseline (Randomized (n=69) STARTED	35	34
Baseline (Randomized (n=69) COMPLETED	33	31
Baseline (Randomized (n=69) NOT COMPLETED	2	3
3 Month Follow-up STARTED	33	31
3 Month Follow-up COMPLETED	30	28
3 Month Follow-up NOT COMPLETED	3	3
6 Month Follow-up STARTED	30	28
6 Month Follow-up COMPLETED	27	28
6 Month Follow-up NOT COMPLETED	3	0
12 Month Follow-up STARTED	27	28
12 Month Follow-up COMPLETED	21	23
12 Month Follow-up NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Physical Therapy Assessment Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
Baseline (Randomized (n=69) Withdrawal by Subject	2	3
3 Month Follow-up Lost to Follow-up	2	2
3 Month Follow-up Withdrawal by Subject	1	1
6 Month Follow-up Lost to Follow-up	3	0
12 Month Follow-up Lost to Follow-up	2	3
12 Month Follow-up Pregnancy	0	1
12 Month Follow-up Surgery	2	0
12 Month Follow-up Wrong address	1	0
12 Month Follow-up No symptoms	1	0
12 Month Follow-up Changed primary care centre	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Therapy Assessment n=35 Participants Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment n=34 Participants Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.	Total n=69 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 11.6 • n=35 Participants	59 years STANDARD_DEVIATION 11.5 • n=34 Participants	60 years STANDARD_DEVIATION 11.6 • n=69 Participants
Sex: Female, Male Female	21 Participants n=35 Participants	23 Participants n=34 Participants	44 Participants n=69 Participants
Sex: Female, Male Male	14 Participants n=35 Participants	11 Participants n=34 Participants	25 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Level of education Primary school	8 Participants n=35 Participants	4 Participants n=34 Participants	12 Participants n=69 Participants
Level of education Secondary school	15 Participants n=35 Participants	20 Participants n=34 Participants	35 Participants n=69 Participants
Level of education Tertiary school	12 Participants n=35 Participants	10 Participants n=34 Participants	22 Participants n=69 Participants
Current Employment Employed/working	19 Participants n=35 Participants	18 Participants n=34 Participants	37 Participants n=69 Participants
Current Employment Unemployed	0 Participants n=35 Participants	1 Participants n=34 Participants	1 Participants n=69 Participants
Current Employment Retired/early retirement	15 Participants n=35 Participants	13 Participants n=34 Participants	28 Participants n=69 Participants
Current Employment Sick leave	1 Participants n=35 Participants	2 Participants n=34 Participants	3 Participants n=69 Participants
Pain duration (months)	14 months STANDARD_DEVIATION 22 • n=35 Participants	10 months STANDARD_DEVIATION 16 • n=34 Participants	12 months STANDARD_DEVIATION 19 • n=69 Participants
BMI	30 kg/m^2 STANDARD_DEVIATION 4.4 • n=35 Participants	29 kg/m^2 STANDARD_DEVIATION 6.7 • n=34 Participants	29 kg/m^2 STANDARD_DEVIATION 5.6 • n=69 Participants
Health-related quality of life (EQ5D-index)	0.73 units on a scale STANDARD_DEVIATION 0.121 • n=35 Participants	0.62 units on a scale STANDARD_DEVIATION 0.222 • n=34 Participants	0.67 units on a scale STANDARD_DEVIATION 0.185 • n=69 Participants
Health-related quality of life (EQ5D-VAS)	73 units on a scale STANDARD_DEVIATION 17.5 • n=35 Participants	68 units on a scale STANDARD_DEVIATION 21.1 • n=34 Participants	70 units on a scale STANDARD_DEVIATION 19.5 • n=69 Participants
Pain intensity (VAS 0-100)	45 units on a scale. STANDARD_DEVIATION 15.9 • n=35 Participants	52 units on a scale. STANDARD_DEVIATION 16.4 • n=34 Participants	49 units on a scale. STANDARD_DEVIATION 16.5 • n=69 Participants
Physical function (30 CST)	12 Chair stands STANDARD_DEVIATION 4.6 • n=35 Participants	11 Chair stands STANDARD_DEVIATION 3.3 • n=34 Participants	12 Chair stands STANDARD_DEVIATION 4.1 • n=69 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Mixed effect model analyses were used to compare the repeated measures of HrQoL between groups. Presenting the estimated marginal means for the final model (adjusted for confounders) at the 12 month follow-up.

Outcome measures

Outcome measures
Measure	Physical Therapy Assessment n=35 Participants Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment n=34 Participants Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-index	0.804 score on a scale Standard Error 0.025	0.825 score on a scale Standard Error 0.024

PRIMARY outcome

Timeframe: 12 months

A Swedish version of Euroqol-5 dimensions-3 levels (EQ5D-3L) will be used to assess perceived self-rated health-related quality of life. The EQ5D-VAS is a visual analogue scale ranging from 0 to 100, where 0 is worst imaginable health state and 100 is best imaginable health state.

Outcome measures

Outcome measures
Measure	Physical Therapy Assessment n=35 Participants Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment n=34 Participants Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
Change From Health Related Quality of Life (HrQoL) at 12 Months - EQ5D-VAS	81 score on a scale Standard Error 2.55	77 score on a scale Standard Error 2.49

SECONDARY outcome

Timeframe: 12 months

The mean pain intensity (over the past month) will be measured by a visual analogue scale (VAS) ranged from 0 which will correspond no pain and 100 the worst imagined pain.

Outcome measures

Outcome measures
Measure	Physical Therapy Assessment n=19 Participants Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment n=17 Participants Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
Change From Pain Intensity at 12 Months	21.79 units on a scale Standard Deviation 18.59	23.29 units on a scale Standard Deviation 18.87

SECONDARY outcome

Timeframe: 12 months

Physical performance will be measured with 30 seconds chair stand test (30CST). Number of chair stands will be counted.

Outcome measures

Outcome measures
Measure	Physical Therapy Assessment n=19 Participants Patients allocated to the intervention group will be assigned to an assessment and evaluation by a physical therapist. If they are diagnosed with knee osteoarthritis they will get an offer to participate in a patient education program and physical training with an individualized exercise program made by a physical therapist. Patients will be offered individual treatment if they decline to participate in the education program, or if they have another diagnosis than osteoarthritis. Anytime after the first assessment by the physical therapist, the patient will be able to contact a physician if they want to. Physical therapy assessment: Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.	Physician Assessment n=22 Participants Allocation to the control group will involve an assessment and evaluation made by a physician. Further measures will then be determined by attending physician and the procedures that might get included are drug prescriptions, referral to x-ray examination, referral to a physical therapist or another health care provider. Anytime after the first assessment by the physician, the patient will be able to contact a physical therapist if they want to, even though if they have not been referred by the physician. Physician assessment: Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
Change From Physical Function at 12 Months	15 stands Standard Deviation 4.9	15 stands Standard Deviation 5.8

SECONDARY outcome

Timeframe: 12 months

Self-efficacy will be assessed with Arthritis Self-Efficacy Scale-Swedish version (ASES-S). Each question range from 10-100, where 10 is very insecure and 100 is very confident. The questionnaire consists three subscales in how patients are experiencing their 1) pain, 2) physical function, 3) other symptoms. Each subscale results in a mean score ranging from 10 to 100 where 10 means very insecure and 100 means very confident. The results of this outcome measure has not been analysed for publication. This outcome measure were excluded in the first manuscript when submitted to scientific journal and will probably be reported in a second manuscript. Anticipated reporting date is December 2024.

Outcome measures

Outcome data not reported

Adverse Events

Physical Therapy Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physician Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

PhD-student, Chan-Mei Ho-Henriksson

Region Västra Götaland, Närhälsan

Phone: +46709892821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place