Wearable Device to Increase Physical Activity Amongst Adults With Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Chronic Pain Conditions
• Intervention / Treatment: Device: Wearable device

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Hughes; Phone Number: 02034488883; Email: John.Hughes@uwl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3HR
    • Recruiting
    • Royal London Hospital for Integrated Medicine, UCLH NHS Foundation Trust
    • Contact: John Hughes; Phone Number: 02034488883; Email: john.hughes8@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of West London
• Collaborators: Royal London Hospital for Integrated Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 314666

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No