Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Range of Motion (ROM) of the Glenohumeral Joint
研究概览
简要总结
The purpose of the study is to compare the efficacy of intra-articular hydraulic distension (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and capsule-preserving IHDs.
详细描述
The Painful stiff shoulder (PSS), or the adhesive capsulitis, involves stiff and contracted joint capsule from fibrosis in the glenohumeral joint. Intra-articular hydraulic distension (IHD) enlarges the stiffened capsule by deforming it with excessive volume and pressure within the joint space. Although IHD is one of the most common treatment options for the PSS, the diversity of the IHD technique spans wide range. Specifically, it is not generally agreed as for which, between capsule-rupturing and capsule-preserving IHDs, is superior for PSS treatment. Capsule-preserving IHD might fail to infuse sufficient amount of fluid to avoid rupture, thus producing less satisfactory outcomes. However, we devised in our previous study a novel technique that enabled a physician to infuse the possible largest volume without rupturing the capsule. By employing the technique, we aim to compare the clinical efficacy of capsule-rupturing versus capsule-preserving IHDs in patients with PSSs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •shoulder discomfort for at least one month
- •limited range of motion of the glenohumeral joint in at least two directions
排除标准
- •systemic inflammatory joint disease
- •radiological evidence of bony abnormality of the shoulder
- •full-thickness rotator cuff tear
- •acute systemic medical illness
- •history of major trauma or surgery involving the shoulder
- •contraindication to intra-articular, local anesthestic injection
结局指标
主要结局
Range of Motion (ROM) of the Glenohumeral Joint
时间窗: 1 month
1. before intervention for all participants 2. using a goniometer 3. patient sitting on a stool with the arm at anatomical position 4. worst: 0 degree 5. best: 360 degree
次要结局
- Pain Measured by Visual Analogue Scale (VAS)(1 month)
