Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
Frozen shoulder, adhesive capsulitis, shoulder, platelet-rich plasma, corticosteroid, injection.
详细描述
This is a prospective assessor-blinded randomized controlled trial. We plan to enroll 90 participants with frozen shoulder from the outpatient clinic of the Department of Physical Medicine and Rehabilitation in our hospital. The study protocol and consent form have been approved by our ethics committee. After detailed explanation about the content of this study, participant is asked to sign an informed consent. The patients will be randomly divided into three groups: 1). PRP injection (PRP group); 2). Corticosteroid injection (CS group); 3). Normal saline injection (NS group). Randomization will be assigned according to a random number from a computer program by a statistician. The patients and the evaluator are unknown which group the patients are allocated, but the physician who performs joint injection knows which group the patients are assigned.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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;
- •shoulder pain for ≥ 1 month;
- •> 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
- •visual analog scale for pain on maximal passive external rotation or abduction > 4;
- •an empty or soft end feel on passive external rotation, or abduction and/or presence of night pain or rest pain;
- •showing willing to attend regular physical therapy programs for 8 weeks.
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 hard end feel on passive external rotation or abduction of the affected shoulder;
- •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
The Shoulder Pain and Disability Index (SPADI)
时间窗: Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
The SPADI is a self-administered questionnaire that evaluate the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consists of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses.
次要结局
- The pain visual analog scale (VAS)(Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.)
- Range of motion（ROM）(Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.)
- Shoulder Disability Questionnaire（SDQ）(Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.)
- Self-assessment of the treatment effect(Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.)
- The 36-item Short Form Health Survey（SF-36）(Change between baseline and at 1 months, 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