Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis

Study Overview
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Brief Summary
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This study is to investigate whether combination of ultrasound-guided subdeltoidcorticosteroid injection and physiotherapy is more effective than either treatment alone in treatment of patients with chronic subacromial (or subdeltoid) bursitis (SAB).

Detailed Description
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Chronic subacromial bursitis (SAB) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, and/or pain on active or passive motions. The diagnosis of SAB requires confirmation by an infiltration with local anesthetic. Previous study showed that corticosteroid injection is more effective than hyaluronic acid in treatment of chronic SAB, however, some (about 20%) patients were not responsive to corticosteroid injection, and some responsive patients may have recurrence of symptoms. The purpose of this study is to investigate whether combination of corticosteroids SASD injections and physiotherapy is more effective than either treatment alone in chronic SAB.

Official Title
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Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis

Conditions
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Subacromial Bursitis, Subacromial Impingement Syndrome, Physical Therapy, Therapeutic Exercise, Rehabilitation

Intervention / Treatment
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* Drug: Triamcinolone SASD injection
* Procedure: Physiotherapy
* Drug: Triamcinolone injections & Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: shoulder pain for more than 1 month age ≥20 years old painful abduction or internal rotation with a visual analog scale (VAS) pain score ≥4 the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with an empty or soft end feel positive shoulder impingement test (Neer test and/or Hawkin test) a reduction in pain of ≥40% on active shoulder abduction or internal rotation at the terminal range after injection of 3ml of 1%lidocain into the SASD bursa under US guidance. Exclusion Criteria: a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and serious infection previous surgery of the affected shoulder any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests andsonographic findings calcification of the rotator cuff, demonstrated by x-ray or sonographic findings the presence of arthritis, such asinflammatory arthritis(e.g., rheumatoid arthritis, seronegativespondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion the presence of instability of the affected shoulder a previous fracture near the shoulder region the presence of cervical radiculopathy or myelopathy having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months.

Ages Eligible for Study
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Minimum Age: 20 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: Triamcinolone SASD injection<br>2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. | Drug: Triamcinolone SASD injection<br>* 2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.<br>|
| Experimental: Physiotherapy<br>The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. | Procedure: Physiotherapy<br>* The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.<br>|
| Experimental: Triamcinolone injections & Physiotherapy<br>2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. | Drug: Triamcinolone injections & Physiotherapy<br>* 2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain VAS score | The pain VAS score is obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain. | change between baseline and at 8 weeks after the beginning of the treatment. | 
| The scores of the Shoulder Pain and Disability Index (SPADI) | The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses. | change between baseline and at 8 weeks after the beginning of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The active ROM | The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction. | change between baseline and at 8 weeks after the beginning of the treatment. | 
| Change of the Shoulder Disability Questionnaire (SDQ) | The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation). | change between baseline and at 8 weeks after the beginning of the treatment. | 
| The Western Ontario Rotator Cuff Index (WORC). | It is composed of 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions. Each item has a score range of 0 to 100.Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life. | change between baseline and at 8 weeks after the beginning of the treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subacromial bursitis, subacromial impingement syndrome, corticosteroid, physical therapy, therapeutic exercise, rehabilitation