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The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid | Experimental | The participants will receive prednisolone for four weeks. |
|
| Exercise | Active Comparator | The participants will receive joint mobilization techniques, stretching and home exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derya Çelik | Istanbul University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Faculty Medicine | Istanbul | Fatih | 34147 | Turkey (Türkiye) | ||
| İÜC Sağlık Bilimleri Fakültesi |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009043 | Motor Activity |
| D009068 | Movement |
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| Exercise | Other | The exercise program will be performed two times per week for six weeks for 12 sessions. |
|
| 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 |
| Istanbul |
| Turkey (Türkiye) |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |