Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.

Detailed Description
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After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double blind manner in a 1:1 (participant and investigator) to oral corticosteroids or exercise.

Official Title
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Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,

Conditions
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Frozen Shoulder

Intervention / Treatment
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* Drug: Corticosteroid
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between ages 18-60 years loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side The pain VAS more than 7 (10 in total) Exclusion Criteria: bilateral frozen shoulder rotator cuff tear previous corticosteroid injection at the affected shoulder within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid<br>The participants will receive prednisolone for four weeks. | Drug: Corticosteroid<br>* The treatment will initiate with a dose of 0.5 mg/kg/day prednisolone for two weeks and the dose will halve in the next two weeks.<br>|
| Active Comparator: Exercise<br>The participants will receive joint mobilization techniques, stretching and home exercise. | Other: Exercise<br>* The exercise program will be performed two times per week for six weeks for 12 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in function on DASH at 6th and 12th week | The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb. | Baseline,6th week and 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in function on ASES at 6th and 12th week | The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function. | Baseline,6th week and 12th week | 
| Change from baseline in range of motion (ROM) at 6th and 12th week | The joint's range of motion is the distance that the joint can extend. | Baseline,6th week and 12th week | 
| Change from baseline in depression and anxiety on HADS at 6th and 12th week | HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring. | Baseline,6th week and 12th week | 
| Change from baseline in pain on VAS at 6th and 12th week | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. | Baseline,6th week and 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frozen shoulder, adhesive capsulitis, corticosteroid, exercise