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临床试验/NCT00992927
NCT00992927已完成不适用

Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2008年3月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (1)

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