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Wearable Device to Increase Physical Activity Amongst Adults With Pain

Primary Purpose

Musculoskeletal Chronic Pain Conditions

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Wearable device
Sponsored by
University of West London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Musculoskeletal Chronic Pain Conditions

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal London Hospital for Integrated Medicine, UCLH NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

wearable device plus standard care

standard care

Arm Description

Outcomes

Primary Outcome Measures

Change in Brief Pain Inventory
Change in Visual Analogue Scale (VAS) of Quality of Life
Change in Visual Analogue Scale (VAS) of pain
Change in Numerical Pain Rating Scale (NPRS)
Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)
Change in Pain Catastrophising Scale
Change in The International Physical Activity Questionnaire (IPAQ)
Change in Chronic Pain Coping Inventory (CPCI)
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

Secondary Outcome Measures

Full Information

First Posted
April 7, 2023
Last Updated
May 5, 2023
Sponsor
University of West London
Collaborators
Royal London Hospital for Integrated Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05860478
Brief Title
Wearable Device to Increase Physical Activity Amongst Adults With Pain
Official Title
Wearable Technology for Promoting Physical Activity in Middle-Aged Adults With Chronic Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West London
Collaborators
Royal London Hospital for Integrated Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Chronic Pain Conditions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
wearable device plus standard care
Arm Type
Experimental
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Wearable device
Intervention Description
The wearable device includes a motion sensor, and is worn around the wrist, and the device records a participant's physical activity .
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in Visual Analogue Scale (VAS) of Quality of Life
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in Visual Analogue Scale (VAS) of pain
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in Numerical Pain Rating Scale (NPRS)
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in Pain Catastrophising Scale
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in The International Physical Activity Questionnaire (IPAQ)
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in Chronic Pain Coping Inventory (CPCI)
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)
Title
Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Time Frame
Participants in both groups will complete outcome measures at baseline (T0), week 4 (T1), week 8 (T2), week 12 (T3), and week 24 (T4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Hughes
Phone
02034488883
Email
John.Hughes@uwl.ac.uk
Facility Information:
Facility Name
Royal London Hospital for Integrated Medicine, UCLH NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3HR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Hughes
Phone
02034488883
Email
john.hughes8@nhs.net

12. IPD Sharing Statement

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Wearable Device to Increase Physical Activity Amongst Adults With Pain

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