Wearable Device to Increase Physical Activity Amongst Adults With Pain

NCT05860478 | Recruiting

• 1 other identifier: 314666
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Chronic Pain Conditions

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

wearable device plus standard care

EXPERIMENTAL

Device: Wearable device

standard care

NO INTERVENTION

Interventions

Wearable device DEVICE

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

wearable device plus standard care

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of West London: lead
• Royal London Hospital for Integrated Medicine: collaborator

Study Sites (1)

Royal London Hospital for Integrated Medicine, UCLH NHS Foundation Trust

London, WC1N 3HR, United Kingdom

RECRUITING

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

John Hughes

CONTACT

02034488883; John.Hughes@uwl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 16, 2023
• Study Start: October 6, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

GB (1)