Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- The pain VAS score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Triamcinolone SASD injection
2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
干预措施: Triamcinolone SASD injection (Drug)
Physiotherapy
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.
干预措施: Physiotherapy (Procedure)
Triamcinolone injections & Physiotherapy
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.
干预措施: Triamcinolone injections & Physiotherapy (Drug)
结局指标
主要结局
The pain VAS score
时间窗: change between baseline and at 8 weeks after the beginning of the treatment.
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.
The scores of the Shoulder Pain and Disability Index (SPADI)
时间窗: change between baseline and at 8 weeks after the beginning of the treatment.
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
次要结局
- Change of the Shoulder Disability Questionnaire (SDQ)(change between baseline and at 8 weeks after the beginning of the treatment.)
- The active ROM(change between baseline and at 8 weeks after the beginning of the treatment.)
- The Western Ontario Rotator Cuff Index (WORC).(change between baseline and at 8 weeks after the beginning of the treatment.)
研究者
Lin-Fen Hsieh
Principal Investigator
Shin Kong Wu Ho-Su Memorial Hospital