Chronic knee pain Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 11/10/2021:
One or more of the following recruitment methods will be used. i) Potential participants will be identified either at the point of referral or when they present
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults > 45 years 2. Chronic knee pain > 3 months and on most days of previous month 3. Knee pain during walking =4 on an 11-point numerical rating scale 4. Activity-related joint pain 5. Has a mobile phone, active email account, and computer with Internet access suitable for receiving/making Skype/Zoom video calls if required
Exclusion criteria
Exclusion criteria: 1. Inflammatory arthritis including gout 2. Joint replacement in the study knee 3. An injection (e.g. steroid) into the study knee joint within the last month 4. An arthroscopy (i.e. keyhole surgery) of the study knee joint in the last three months 5. Enrolled in another research study involving an intervention for OA treatment or management 6. Unable to comply with the study protocol 7. Unable to understand written and spoken English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 25/04/2022: This study uses measures of proof of concept/feasibility and patient-reported outcomes. As this is a feasibility study, it is to be noted that primary and secondary outcomes do not need to be specified. The criteria for success of the feasibility study are: 1. Demonstration that participants and physiotherapists find e-rehabilitation acceptable and can be administered successfully 2. Calculation of a sample size from the feasibility study that can be achieved in a main trial 3. At most 30% attrition at 3 months 4. At least 40-50% of eligible patients recruited into the study Patient-reported outcomes are: 1. Pain measured using a joint pain manikin, 5-point scale (frequency of pain), a medication use questionnaire, and Part 1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), at baseline, and at 3 and 9 months 2. Quality of life measured using the 12-Item Short Form Survey (SF-12), and EQ-5D-5L (EuroQoL Group) questionnaires at baseline, and at 3 and 9 months 3. Pain catastrophising and coping assessed using the Hospital Anxiety and Depression Scale (HADS) and 8-point Arthritis Self-Efficacy Scale (ASES-8) at baseline, and at 3 and 9 months 4. Resource use measured with a ‘Use of Hospital/Community Services’ questionnaire at baseline, and at 3 and 9 months 5. Confidence (no confidence to very confident) and motivation (no motivation to very motivated) to do exercises, measured using an 11-point numeric rating scale at baseline, and at 3 and 9 months 6. Global change (overall pain and mobility/function), measured using a 7-point Likert scale (much worse to much better), and data from WOMAC Parts 2 & 3 at 3 and 9 months Previous primary outcome measures: Feasibility of two different e-rehabilitation programmes: 1. Demonstration that participants and physiotherapists find e-rehabilitation acceptable and can be administered successfully 2. Calculation of a sample size from the feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/04/2022: As mentioned above, this is a feasibility study and therefore, it is acceptable not to specify primary and secondary outcomes. Previous secondary outcome measures: 1. Pain is measured using a joint pain manikin, 5-point scale (frequency of pain), a medication use questionnaire, and Part 1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), at baseline, and at three and nine months 2. Quality of life is measured using the 12-Item Short Form Survey (SF-12), and EQ-5D-5L (EuroQoL Group) questionnaires at baseline, and at 3 and 9 months 3. Pain catastrophising and coping is assessed using the Hospital Anxiety and Depression Scale (HADS) and 8-point Arthritis Self-Efficacy Scale (ASES-8) at baseline, and at 3 and 9 months 4. Resource use will be measured with a ‘Use of Hospital/Community Services’ questionnaire at baseline, and at 3 and 9 months 5. Global change (overall pain and mobility/function) is measured using a 7-point Likert scale (much worse to much better), and data from WOMAC Parts 2 & 3 at 3 and 9 months | — |
Countries
England, United Kingdom
Outcome results
None listed