Wearable Technology for Promoting Physical Activity in Middle-Aged Adults With Chronic Musculoskeletal Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This protocol is for a pragmatic mixed methods randomized parallel-group exploratory feasibility trial to examine all facets of a proposed future phase III trial on the use of wearable device to increase physical activity and possibly reduce pain amongst middle-aged people with musculoskeletal (MSK) chronic pain. The feasibility study is intended to answer the following research questions: Question 1 Evaluate the acceptability of all aspect of the study design of wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain. Question 2: Is it feasible and acceptable to use wearable devices as an intervention to increase physical activity in middle-aged adults with musculoskeletal chronic pain? Question 3: How can using wearable device promote physical activity effectively in middle-aged adults with musculoskeletal chronic pain? Participants will be recruited from a National Health Service (NHS) pain clinic and randomised on a ratio1:3 into control group (standard care) and intervention group (standard care combined with wearable device). The feasibility study will last for 18 months, participants involvement will be for 24 weeks. Patients in both groups can participate in any physical activity, including planned, structured, and repetitive bodily movement exercise or occupational and recreational PA. Qualitative semi-structured interview will be conducted at baseline and week-12, while outcome measures will be conducted at baseline, 4-week, 8-week,12-week, and 24-week for all participants to examine their pain, physical activity, and their responses to the trial. Qualitative interview will be conducted for stakeholders which include clinicians and service managers after all patient data has been collected. This study has the potential to make an original contribution to provide key data on the feasibility, acceptability, and effectiveness of using wearable technology to support physical activity intervention for middle-aged adults with musculoskeletal chromic pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:

• Patient of any gender identity 40-65 years old.

• Willingness to participate in the trial.

• Able to understand and speak sufficient English to engage during interviews.

• They have self-reported persistent or recurrent musculoskeletal pain for three months or longer.

• Participants will be receiving treatment for musculoskeletal chronic pain.

Locations
Other Locations
United Kingdom
Royal London Hospital for Integrated Medicine, UCLH NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
John Hughes
John.Hughes@uwl.ac.uk
02034488883
Time Frame
Start Date: 2023-10-06
Estimated Completion Date: 2024-04
Participants
Target number of participants: 40
Treatments
Experimental: wearable device plus standard care
No_intervention: standard care
Related Therapeutic Areas
Sponsors
Leads: University of West London
Collaborators: Royal London Hospital for Integrated Medicine

This content was sourced from clinicaltrials.gov