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Wearable Device to Increase Physical Activity Amongst Adults With Pain

U

University of West London

Status

Enrolling

Conditions

Musculoskeletal Chronic Pain Conditions

Treatments

Device: Wearable device

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

wearable device plus standard care
Experimental group
Treatment:
Device: Wearable device
standard care
No Intervention group

Trial contacts and locations

1

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Central trial contact

John Hughes

Data sourced from clinicaltrials.gov

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