Wearable Device to Increase Physical Activity Amongst Adults With Pain

Sponsor
University of West London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05860478
Collaborator
Royal London Hospital for Integrated Medicine (Other)
40
1
2
11
3.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wearable device
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Wearable Technology for Promoting Physical Activity in Middle-Aged Adults With Chronic Musculoskeletal Pain
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: wearable device plus standard care

Device: Wearable device
The wearable device includes a motion sensor, and is worn around the wrist, and the device records a participant's physical activity .

No Intervention: standard care

Outcome Measures

Primary Outcome Measures

  1. Change in Brief Pain Inventory [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  2. Change in Visual Analogue Scale (VAS) of Quality of Life [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  3. Change in Visual Analogue Scale (VAS) of pain [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  4. Change in Numerical Pain Rating Scale (NPRS) [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  5. Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  6. Change in Pain Catastrophising Scale [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  7. Change in The International Physical Activity Questionnaire (IPAQ) [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  8. Change in Chronic Pain Coping Inventory (CPCI) [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

  9. Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) [Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Palliative patient.

  • Patients of any gender identity younger than 40-year-old or older than 65-year-old.

  • Patients that are dependent on alcohol or drugs.

  • Involvement with other ongoing studies.

  • Patients unable to complete the questionnaires as judged by the researcher.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal London Hospital for Integrated Medicine, UCLH NHS Foundation Trust London United Kingdom WC1N 3HR

Sponsors and Collaborators

  • University of West London
  • Royal London Hospital for Integrated Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Hughes, Associate Professor, University of West London
ClinicalTrials.gov Identifier:
NCT05860478
Other Study ID Numbers:
  • 314666
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023