Musculoskeletal pain Musculoskeletal Diseases
Conditions
Interventions
This is a two-arm individually randomised feasibility study with embedded process evaluation comparing the TRAK-MSK intervention to usual care (UC) for patients over the age of 18 years with activity-
Sponsors
Cardiff and Vale University Health Board
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged over 18 years 2. Referred or self-referring for physiotherapy 3. Activity-related joint pain 4. Have either no self-reported morning joint stiffness or morning stiffness that lasts no longer than 30 minutes 5. Have self-reported pain for more than 3 months and on most days of the previous month
Exclusion criteria
Exclusion criteria: Musculoskeletal pain participants will be excluded if: 1. There is a contraindication to exercise 2. They have pain caused by malignancy 3. They have fractures or inflammatory arthritis 4. They have received surgery for their MSK pain in the last 12 months 5. They are unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of a future definitive trial, assessed using: 1. The feasibility of recruitment in three trial sites (Cardiff and Vale, Powys and Cwm Taf) 2. Participants' willingness to be randomised after consenting, recorded as the number of eligible participants who consent to participate in the study by 12 months 3. The acceptability to participants of completing outcome measures (completion rates and perceived burden) 4. The feasibility of obtaining follow-up data by analysing follow up rates (proportion of participants completing 6-month follow-up assessment) 5. Participants’ engagement with the intervention (the number of online consultation and logins, pages visited, number of visits to goals and activity plans, number of activity logs and frequency of email correspondence) 6. The safety of the intervention (self-reported issues such as increased pain symptoms or muscle soreness) 7. The acceptability of the intervention through interviews with participants about their confidence to self-manage, digital literacy, technology acceptance and barriers and facilitators to participating All of the primary outcome measures will be assessed as part of the final analysis which will be completed at months 16 and 17. The researchers will also evaluate whether the following continuation criteria have been met, prior to planning a future definitive trial: progression criteria are based on a traffic light system (green, amber, red) for the TRAK intervention. Recruitment and randomisation rates, along with outcome measures completion will be monitored at the monthly project management meeting. If at the end of the study all feasibility progression criteria are achieved (green), then the recommendation would be to move to a full RCT. Remediable modifications in the study processes or the intervention may be required if progression criteria are not fully achieved (amber). If there is no identifiable reason or remediable action that can be taken (red), then progression to a | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of musculoskeletal conditions measured using the Musculoskeletal Health Questionnaire (MSK-HQ) at baseline and 6 months 2. Pain measured using the Numeric Pain Scale (NRS) at baseline and 6 months 3. Depression measured using the Patient Health Questionnaire for depression (PHQ-9) at baseline and 6 months 4. Symptom severity of four common anxiety disorders measured using the General Anxiety Disorder Scale (GAD-7) at baseline and 6 months 5. Health-related quality of life measured using the EQ-5D 5L at baseline and 6 months 6. Participants' confidence in performing activities while in pain measured using the Pain Self-Efficacy Scale (PSEQ) at baseline and 6 months 7. Capability and well-being measured using the ICEcap Capability measure for Adults (ICECAP-A) at baseline and 6 months as part of an economic evaluation 8. Comorbid conditions assessed using the Self-reported Comorbidity Questionnaire at baseline | — |
Countries
United Kingdom, Wales
Outcome results
None listed