Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Corticosteroid The participants will receive prednisolone for four weeks. |
Drug: Corticosteroid
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.
|
| Active Comparator: Exercise The participants will receive joint mobilization techniques, stretching and home exercise. |
Other: Exercise
The exercise program will be performed two times per week for six weeks for 12 sessions.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in function on DASH at 6th and 12th week [Baseline,6th week 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.
Secondary Outcome Measures
- Change from baseline in function on ASES at 6th and 12th week [Baseline,6th week 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.
- Change from baseline in range of motion (ROM) at 6th and 12th week [Baseline,6th week and 12th week]
The joint's range of motion is the distance that the joint can extend.
- Change from baseline in depression and anxiety on HADS at 6th and 12th week [Baseline,6th week 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.
- Change from baseline in pain on VAS at 6th and 12th week [Baseline,6th week 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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between ages 18-60 years
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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
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The pain VAS more than 7 (10 in total)
Exclusion Criteria:
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bilateral frozen shoulder
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rotator cuff tear
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previous corticosteroid injection at the affected shoulder within 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istanbul Faculty Medicine | Istanbul | Fatih | Turkey | 34147 |
| 2 | İÜC Sağlık Bilimleri Fakültesi | Istanbul | Turkey |
Sponsors and Collaborators
- Istanbul University
Investigators
- Study Director: Derya Çelik, Istanbul University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Istanbul Unıversity-Cerrahpasa