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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13131384
Enrollment
356
Registered
2024-10-25
Start date
2025-02-24
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful distal upper limb musculoskeletal disorders Musculoskeletal Diseases

Interventions

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

Sponsors

University of Leeds
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Functional disability/symptoms are measured using QuickDASH (Disabilities of the Arm, Shoulder and Hand) at 6-months

Secondary

MeasureTime frame
1. Functional disability/symptoms are measured using QuickDASH (Disabilities of the Arm, Shoulder and Hand) at baseline, 3, 6, 9 and 12-months. 2. Pain is measured using a multi-joint pain questionnaire at baseline and the Numerical Pain Rating Scale (NPRS) at baseline, 3, 6, 9 and 12-months. 3. Anxiety and depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline. 4. Health-related quality-of-life is measured using EQ-5D-5L and a Patient Global Assessment question at baseline, 3, 6, 9 and 12-months. 5. Work limitation is measured using a Work Ability Numerical Rating Scale (NRS), the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and 3 questions from the iProductivity Cost Questionnaire (iPCQ). 6. Resource use and cost data will be measured using the Modified Client Service Receipt Inventory (CSRI) at baseline, 3, 6, 9 and 12-months. 7. Process outcomes will be measured using the Discrete Choice Experiment (DCE) at baseline, 3, 6, 9 and 12-months. 8. Confidence using the internet will be measured using a 5-point Likert scale at baseline. 9. Motivation to do exercises will be measured using a Numerical Rating Scale (NRS) at baseline, 3, 6, 9 and 12-months. 10. Data relating to the longer term usage of/adherence to D-MAPP will be collected over 12 months from routine monitoring of web-based exercise views & material downloads (intervention group only).

Countries

England, United Kingdom

Contacts

Public ContactDawn Groves-Williams
CTRU.D-MAPP@leeds.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026