NCT05980572Befejeződött
Effects of App-assisted Home Exercise Program in Patients With Frozen Shoulder
Mobile Device Based Telerehabilitation for Frozen Shoulder-A Prospective Randomized Controlled Study.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 21 (tényleges)
- Első benyújtás
- 2022. nov. 21.
- Kezdés
- 2022. szept. 11.
- Elsődleges befejezés
- 2023. okt. 20.
- Fő szponzor
- Chang Gung Memorial Hospital
- NCT-szám
- NCT05980572
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 21
- 2022. szept. 11. és az elsődleges befejezés (2023. okt. 20.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 20 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | Tajvan | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.