Testing a new digital program to help reduce arm pain and improve movement in people with upper limb disorders

Development and evaluation of the Digital-My Arm Pain Programme for improving painful distal upper limb musculoskeletal disorders

Registry ID
ISRCTN13131384
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of Leeds
Enrollment
356
Start date
2025-02-24
Completion date
2028-02-28
Last update
2026-08-17

Conditions

Summary

Painful distal upper limb musculoskeletal disorders

Detailed description

Participants will be asked to complete a questionnaire booklet at baseline, prior to randomisation, and then follow-up questionnaires at 3-, 6-, 9- and finally 12-months post randomisation. Consent to access patient medical notes as required will be requested, for example if needed to investigate a reported event of interest during the 12-month follow-up period. Questionnaire booklets will be provided electronically via REDCap, but participants can choose to complete paper versions. The CTRU will be responsible for managing the electronic databases/questionnaire platforms and collection of paper questionnaires. Participants will be sent an electronic, followed by postal reminder if questionnaires are not completed. If required, a third reminder will be used where the participant will be asked to complete the questionnaire over the phone. The primary outcome measure is the participant reported QuickDASH at 6 months post randomisation. QuickDASH reports functional disability, symptoms, and participation levels experienced by people with upper limb disorders. Full details of the trial data analysis will be specified in a predetermined, approved, version-controlled statistical analysis plan. Participants allocated to the intervention arm (D-MAPP) will be sent instructions about how to download the web-app and will be asked to use D-MAPP for at least 12 weeks and to continue using the app during the 12 month follow up. The app contains accessible self-management resources (information/guidance), a symptoms diary, and a guided exercise programme tailored to the individual's distal upper limb condition. As part of the D-MAPP intervention participants will receive equipment (stress ball and resistance band) where required. The healthcare professional registering the participant will assign the user type based on their diagnosis and this will ensure they have access to resources and exercises relevant for their condition. The primary feature of the D-MAPP intervention is a

Interventions

Inclusion criteria

1. Age >=18 years 2. Clinician-diagnosed DUL-MSD 3. DUL-MSD symptom duration of at least 6 weeks 4. Ability to provide informed consent 5. At least moderate pain (> = 4 on numeric rating scale where 0=no pain and 10=pain as bad as it could be) for most days of the prior 4 weeks 6. No changes to patient’s usual use or type of analgesia taken for the DUL-MSD during the previous 4 weeks

Exclusion criteria

1. A patient who has distal upper limb pain/symptoms due to any of the following conditions: 1.1. Referred pain from the neck/spine 1.2. Systemic inflammatory conditions or inflammatory arthritis, including (but not limited to) gout, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, or polymyalgia rheumatica 1.3. Traumatic peripheral nerve injury or peripheral neuropathy due to systemic illness (e.g., diabetes). Mild carpal tunnel syndrome is NOT to be excluded 1.4. Neurological conditions (e.g., stroke, multiple sclerosis) 1.5. Ulnar nerve entrapment or trigger finger 2. Any upper limb fracture in the last 12 months 3. Diagnosis of complex regional pain syndrome 4. Any widespread body pain syndrome that in the view of the investigator would interfere with the assessment of upper limb pain 5. Any DUL condition (e.g., moderate to severe carpal tunnel syndrome) that in the opinion of the investigator warrants referral to surgery 6. Surgical intervention for any condition in either arm/shoulder in the previous six months 7. Any planned surgical intervention for any condition likely to take place in the next three months 8. Steroid injection in either arm/shoulder in the previous eight weeks or planned in the next 12 weeks 9. Any condition (e.g., moderate/severe asthma, inflammatory bowel disease, chronic obstructive pulmonary disease) where the participant has required the use of steroids in the last two years 10. Cancer within the last 3 years or currently receiving treatment for cancer 11. Unable to follow the study protocol and/or comply with or adhere to the intervention 12. Previously randomised to the D-MAPP trial 13. Currently pregnant or has given birth in the last 3 months 14. Ongoing litigation or work disputes relating to their DUL condition

Locations

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