The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index(SPADI)
研究概览
简要总结
The effect of combination of hydrodilatation, corticosteroid injection, and joint mobilization for treatment of frozen shoulder, compared with general physical therapy.
详细描述
Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and active range of motion (ROM) of glenohumeral joint, and leads to disability, functional limitation, and decreasing quality of life. FS is usually treated with conservative treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation, intra-articular steroid injection, etc.. The short-term effect of each treatment is variable, and the long-term effect is not established. Clinically combination of each treatment is common, but types of combination, and the effect of combination is still not well studied. We aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and general physiotherapy to treat frozen shoulder and compare the long-term effect with general physical therapy alone.
This is a prospective single-blind randomized controlled trial. 70 participants will be recruited from the outpatient clinic of the department of Physical Medicine and Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline) through both anterior and posterior shoulder joint in a two-weekly interval. In addition, joint mobilization and general physiotherapy (stretch exercise and physical modalities) will also be given, 2 times a week, for 8 weeks. The PT group will receive general physical therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36), and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations. We expect that the COMB group will recover sooner and better than the PT group.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. age between 20 to 80 years old;
- •. chronic shoulder pain for ≥ 3 months;
- •. > 30% loss of passive range of motion (ROM) of the affected shoulder in either external rotation or abduction, comparing with the sound side;
- •. visual analog scale for pain on maximal passive external rotation or abduction > 4.
排除标准
- •. Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
- •. Uncontrolled DM;
- •. Rotator cuff tear or calcification of the affected shoulder;
- •. Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
- •. a history of drug allergy to local anesthetics or corticosteroids;
- •. receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.
结局指标
主要结局
Shoulder Pain and Disability Index(SPADI)
时间窗: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
次要结局
- The 36-item Short Form Health Survey(SF-36)(change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.)
- Shoulder Disability Questionnaire(SDQ)(change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.)
- Visual analog scale(VAS)(change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.)
- Range of motion(ROM)(change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.)
研究者
Lin-Fen Hsieh
Principal Investigator
Shin Kong Wu Ho-Su Memorial Hospital
