Frozen Shoulder Clinical Trial
Official title:
Mobile Device Based Telerehabilitation for Frozen Shoulder-A Prospective Randomized Controlled Study.
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 pain evaluated by 11-point numeric rating scale. The secondary outcomes will include shoulder passive range of motion (measured with a universal goniometer), , 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 | Recruiting |
Enrollment | 76 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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: 1. Unilateral frozen shoulder. 2. Suitability for treatment with intra-articular and subacromial glucocorticosteroid injection. 3. 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. 4. 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: 1. Age younger than 20 years old. 2. Bilateral involvement of the shoulder. 3. Secondary frozen shoulder resulting from trauma. 4. History of shoulder joint injections or upper limb surgery within the past month. Presence of rheumatoid arthritis, central nervous system disorders, or cervical radiculopathy. 5. Cognitive disorders or inability to understand exercise instructions. 6. Contraindications for anesthesia or corticosteroid injection. 7. Lack of familiarity with using smartphones. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Shoulder pain by Numeric Rating Scale (NRS) | To assess shoulder pain, investigators will utilize an 11-point NRS. Patients will be informed that a score of 0 represents no pain, while a score of 10 indicates the highest level of pain. | prior to randomization, 4-weeks after interventions and 12-weeks after intervention | |
Secondary | Change of Oxford shoulder score (OSS). | A patient-rated outcome measure of shoulder pain and function in patients with shoulder pain. OSS has twelve questions with five possible responses ranging from 0 (worst) to 4 (best). | prior to randomization, 4-weeks after interventions and 12-weeks after intervention | |
Secondary | Change shoulder active range of motion in degree | The range of motion of the shoulder will be assessed using a universal goniometer, which measures the angle of movement between specific bone landmarks. The investigator will evaluate the active range of motion of the affected shoulder, including flexion, abduction, internal rotation, and external rotation, using the goniometer to determine the degrees of movement in each direction. Active range of movement of the affected shoulder, including flexion, abduction, internal rotation, and external rotation, will be measured by goniometer in degree. | prior to randomization, 4-weeks after interventions and 12-weeks after intervention | |
Secondary | Change of Quick Disability of the Arm, Shoulder and Head (QuickDASH) score | The QuickDASH is a modified version of the original 30-item Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, consisting of 11 items. A minimum of 10 items must be completed by the participant. Each item has five response options.The total QuickDASH score ranges from 0 (indicating no disability) to 100 (representing the most severe disability) | prior to randomization, 4-weeks after interventions and 12-weeks after intervention | |
Secondary | Selected part of revised Technology Acceptance Model (TAM-2) | The selected part of revised Technology Acceptance Model(TAM-2) including intention to use, perceived usefulness and perceived ease of use. Participants will be asked to rate their agreement with each statement on a five-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree." | 4 weeks after intervention in App intervention group | |
Secondary | System Usability Scale (SUS) | he SUS is a standardized questionnaire that consists of ten statements related to the usability of the application. Participants will be asked to rate their agreement with each statement on a five-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree." | 4 weeks after intervention in App intervention group | |
Secondary | Usability, Satisfaction and Ease of Use (USE) questionnaire | The questionnaire consists of four statements related to the system or application being evaluated. Participants will be asked to rate their agreement with each statement on a five-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree." | 4 weeks after intervention in App intervention group |
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