A feasibility study of a digital self-management physiotherapy intervention for individuals with musculoskeletal pain
| ISRCTN | ISRCTN82011326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82011326 |
| IRAS number | 310033 |
| Secondary identifying numbers | IRAS 310033, CPMS 52142 |
- Submission date
- 10/05/2022
- Registration date
- 15/07/2022
- Last edited
- 11/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Pain in the muscles, joints, bones and soft tissues (musculoskeletal [MSK] pain) affects 18.8 million people in the UK. In Wales about 1 in 3 people have an MSK condition, with back pain and knee osteoarthritis being the most common conditions. Conservative treatments such as exercise and physiotherapy are recommended but they appear to have limited benefit in helping people manage their condition at home, as they often struggle to keep going with regular exercise. Technology like TRAK-MSK has the potential to make a difference. TRAK-MSK is a new digital physiotherapy intervention for people with MSK pain, that helps people to manage their exercise and pain at home. In this intervention individuals can have up to five online consultations with a specially physiotherapist trained in self-management. The timing and number of appointments will be decided by the participant. Individuals will have immediate access to the TRAK-MSK website throughout, which provides information, personalised video-based exercise plans, progress tracker, individual set challenges and remote access to a physiotherapist. The combination of online consultations with a specially trained physiotherapist and access to the TRAK-MSK website will support individuals to practice and gain the skills to manage their condition themselves at home.
The aim of this study is to find out if the TRAK-MSK intervention can be delivered and if people find it acceptable. This study will ask whether people with MSK pain can be recruited and retained in clinical studies of TRAK-MSK and what it costs to deliver the TRAK-MSK intervention. The researchers will see if TRAK-MSK increases people’s confidence to independently manage their pain and help them remain physically active.
Who can participate?
Patients over the age of 18 years with activity-related MSK pain originating from their back, legs or arms
What does the study involve?
Participants will be asked to fill out a screening questionnaire online to check if they are eligible to take part. If eligible, they will be asked to complete an informed consent form on the TRAK-MSK website. Following that, they will be asked to complete a number of questions on the TRAK-MSK website asking about joint pains and how they are coping with them. Participants will then be randomly allocated to receive either the TRAK-MSK intervention for 4 months or they will continue with their usual NHS care that is available in the area they live for 4 months.
If offered the TRAK-MSK intervention, they will receive up to five one-to-one sessions with a clinical practitioner through video call. These sessions will take place over a 4-month period to help self-management of joint pain. After 6 months, regardless of which treatment they received, they will be asked to fill out the same questionnaires as at baseline. At the end of the trial, we may ask some participants about their experiences of being in the trial.
What are the possible benefits and risks of participating?
At this stage of the research, the direct health benefits for participants are unknown, but participants will help the researchers to gather evidence about the effectiveness of using an online intervention to aid patients in self-managing their joint pain. There is a chance that participants might find some topics sensitive or upsetting while taking part in the one-to-one support sessions, or whilst taking part in the interview.
Where is the study run from?
Cardiff and Vale University Health Board with support from the Centre for Trials Research at Cardiff University (UK)
When is the study starting and how long is it expected to run for?
December 2021 to June 2023
Who is funding the study?
The study is funded by the Welsh Government through the Health and Care Research Wales (Research for Patient and Public Benefit (RfPPB) scheme (UK)
Who is the main contact?
Andrew Dean-Young
TRAKMSK@Cardiff.ac.uk
Contact information
Principal Investigator
School of Healthcare Sciences
College of Biomedical and Life Sciences
Cardiff University
Room 13.17, 13th Floor, Eastgate House
35 - 43 Newport Road
Cardiff
CF24 0AB
United Kingdom
| Phone | +44 (0)29 20 687734 |
|---|---|
| ButtonK@cardiff.ac.uk |
Study information
| Study design | Two-arm individually randomised feasibility study with embedded process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | TRAK-MSK: a randomised controlled feasibility study of TRAK musculoskeletal digital self-management physiotherapy intervention for individuals with musculoskeletal pain |
| Study acronym | TRAK-MSK feasibility |
| Study hypothesis | To evaluate whether the TRAK musculoskeletal digital self-management intervention (TRAK-MSK), for people with soft tissue or joint pain (MSK pain), can be delivered within physiotherapy outpatient services and whether people can be recruited and retained for this study. |
| Ethics approval(s) | Approved 05/04/2022, London - Queen Square Research Ethics Committee (HRA NRES Centre Bristol, 3rd Floor, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048225, +44 (0)2071048109; queensquare.rec@hra.nhs.uk), ref: 22/LO/0141 |
| Condition | Musculoskeletal pain |
| Intervention | 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-related MSK pain, who are referred for physiotherapy outpatients. The TRAK-MSK intervention will be delivered over a 4-month period by self-management trained physiotherapists. Core intervention activities involve: 1. Online consultations delivered by trained physiotherapists 2. Use of the TRAK-MSK website Participants will be asked to fill out a screening questionnaire online to check if they are eligible to take part. If eligible, they will be asked to complete an informed consent form on the TRAK-MSK website. Following that, they will be asked to complete a number of questions on the TRAK-MSK website asking about joint pains and how they are coping with them. Participants will then be randomly allocated to receive either the TRAK-MSK intervention for 4 months or they will continue with their usual NHS care that is available in the area they live for 4 months. The randomisation will have an allocation ratio of 1:1 within each stratum and across the study. Participants will be stratified by site. Randomisation will be completed via secure web access to the remote randomisation site. If offered the TRAK-MSK intervention, they will receive up to five one-to-one sessions with a clinical practitioner through video call. These sessions will take place over a 4-month period to help self-management of joint pain. After 6 months, regardless of which treatment they received, they will be asked to fill out the same questionnaires as at baseline. At the end of the trial, we may ask some participants about their experiences of being in the trial. |
| Intervention type | Other |
| Primary outcome measure | 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 full trial would not be recommended. Intervention adherence and fidelity are not formal progression criteria but will be closely monitored and considered in any final recommendations. 1. Recruited participants per month per site (Cardiff and Vale/Powys/Cwm Taf). Number of participants at each site: 10/5/5 = Green; 8/3/3 = Amber; 6/2/2 = Red 2. Participants willingness to be randomised: 70% or higher = Green; 50-70% = Amber; 49% or lower = Red 3. The completeness of PROMS’s outcome data at 6-month follow-up: 70% or higher = Green; 60-70% = Amber; 59% or lower = Red |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2021 |
| Overall study end date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/07/2022 |
| Recruitment end date | 28/02/2023 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Albert Road
Pontypridd
CF37 1LB
United Kingdom
Bronllys
Brecon
LD3 0LY
United Kingdom
Sponsor information
Hospital/treatment centre
2nd Floor Lakeside Building
Heath Park
Cardiff
CF14 4XW
Wales
United Kingdom
| Phone | +44 (0)2920 747747 |
|---|---|
| CAV_research.development@wales.nhs.uk | |
| Website | http://www.cardiffandvaleuhb.wales.nhs.uk/home |
"ROR" |
https://ror.org/0489f6q08 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Welsh Government, The Welsh Government
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings will be circulated to a variety of audiences and tailored accordingly. We will hold a feedback event for key stakeholders. Findings will be distributed publicly via NHS and university websites, social media accounts and press releases in collaboration with Cardiff and Vale and Cardiff University press offices. Our findings will be presented to the academic community via publication in open access peer reviewed academic journals and at an international conference. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/05/2023: The overall end date was changed from 31/05/2023 to 30/06/2023.
13/01/2023: The recruitment end date has been changed from 31/01/2023 to 28/02/2023.
07/12/2022: The recruitment end date was changed from 31/12/2022 to 31/01/2023.
17/10/2022: The recruitment end date was changed from 31/10/2022 to 31/12/2022.
04/08/2022: Internal review.
11/05/2022: Trial's existence confirmed by the London - Queen Square Research Ethics Committee.
