NCT05980572Completed
Effects of App-assisted Home Exercise Program in Patients With Frozen Shoulder
Mobile Device Based Telerehabilitation for Frozen Shoulder-A Prospective Randomized Controlled Study.
Source: ClinicalTrials.gov · Last updated 3 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 21 Nov 2022
- Start date
- 11 Sept 2022
- Primary completion date
- 20 Oct 2023
- Lead sponsor
- Chang Gung Memorial Hospital
- NCT number
- NCT05980572
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 11 Sept 2022 to the primary completion date, 20 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Eligibility Criteria:
- Patients with frozen shoulder who are scheduled to receive intra-articular glucocorticosteroid injections, as determined by the physician investigator, will be consecutively enrolled in the study. To be included in the study, patients must meet the following criteria:
- Unilateral frozen shoulder.
- Suitability for treatment with intra-articular and subacromial glucocorticosteroid injection.
- Patients must fulfill the diagnostic criteria for frozen shoulder, as described by Bulgen et al. These criteria include shoulder pain persisting for at least 1 month, sleep disturbance (such as night pain or inability to lie on the affected side), restriction of all active and passive shoulder movements, and a reduction of passive glenohumeral external rotation by at least 50% compared to the unaffected side.
- Plain radiographs of the shoulder will be obtained to exclude other pathologies.
- Patients will be excluded from the study if they meet any of the following criteria:
- Age younger than 20 years old.
- Bilateral involvement of the shoulder.
- Secondary frozen shoulder resulting from trauma.
- History of shoulder joint injections or upper limb surgery within the past month.
- Presence of rheumatoid arthritis, central nervous system disorders, or cervical radiculopathy.
- Cognitive disorders or inability to understand exercise instructions.
- Contraindications for anesthesia or corticosteroid injection.
- Lack of familiarity with using smartphones.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.