drugset / Trial / NCT05980572

Effects of App-assisted Home Exercise Program in Patients With Frozen Shoulder

NCT05980572

Completed 21 enrolled Chang Gung Memorial Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Abstract Introduction Frozen shoulder is a common musculoskeletal disorder with reported lifetime prevalence to be 2%\~5% in the general population. Patients with frozen shoulders present with chronic pain and limited range of motion of affected shoulder and often cause an adverse impact on their daily activities and working ability. Shoulder exercises had been proven to be effective in treatment of frozen shoulders and the effects were even better after intraarticular corticosteroid injection. Strategies to enhance home exercise for patients with frozen shoulders are essential. Objective To compare the effects of home exercises delivered by a newly developed app named Defrozen app with that by convention home exercise for frozen shoulder patients after intra-articular corticosteroid injection. Methods and analysis This is a randomized, controlled, assessor-blinded clinical trial. Seventy-eight individuals diagnosed with frozen shoulders will be randomly divided into two groups. The primary outcome will be shoulder passive range of motion (measured with a universal goniometer). The secondary outcomes will include , shoulder pain evaluated by 11-point numeric rating scale , Oxford shoulder score and Disabilities of the arm, shoulder and hand questionnaire. Feasibility of the app includes including Technology Acceptance Model (TAM-2), System Usability Scale (SUS) and Usability, Satisfaction and Ease of Use (USE) questionnaire . The treatment will be conducted for 6 months (Defrozen app home exercise x conventional home exercise by instructions from printed pamphlets).All participants will receive outcome measurements assessment prior to randomization , 4 weeks , 12 weeks after injections interventions. Feasibility will be evaluated 4 weeks after intervention in the Defrozen app group. Ethics and dissemination The study protocol was approved by the Institutional Review Board. The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.

Timeline

Start
2022-09-11
Primary completion
2023-10-20
Completion
2023-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Aceclofenac Small molecule
Background Lidocaine Other / unclassified 1 % Other
Background Triamcinolone Acetonide Other / unclassified 40 mg/ml Other

Indications