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临床试验/NCT00160784
NCT00160784已完成4 期

Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis of the Shoulder - A Prospective Randomized Study

University of Florida2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 1997年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
58
试验地点
2
主要终点
At the end of two years, the SPADI test, Range of Motion test and Strength test will be used to determine the effect of the intervention.

研究概览

简要总结

The purpose of this study is to compare two treatments used for treating frozen shoulder which are arthroscopy and forceful stretching of the shoulder and home stretching therapy to see if one relives pain and improves shoulder motion more quickly. The other purpose is to try and understand what causes frozen shoulder. For this purpose, tissue will be taken from the shoulder during surgery and studied for the presence and level of a protein called cytokine (Connective Tissue Growth Factor)

详细描述

Adhesive capsulitis of the shoulder is a relatively common entity which is poorly understood and produces a significant amount of morbidity in afflicted patients. The natural history of adhesive capsulitis is only just beginning to be understood. It is a self-limiting disease, but may take 18 to 36 months to resolve. During that time, individuals can suffer a significant amount of pain and miss a large amount of work. Many surgeons have treated this process with early manipulation with the outcome never being reported in a prospective manner. Some authors have advocated conservative non-operative treatment, knowing the natural history in most of these shoulders will be near resolution. The primary purpose of this study is to examine in a prospective randomized manner the results of continuous non-operative management versus arthroscopic capsulectomy. This study will determine if operative intervention with an arthroscopic capsulectomy can shorten the natural history of adhesive capsulitis, and give comparable results with non-operative management at final follow-up of 2 years.

A second purpose of the study is to try and identify the mechanism(s) responsible for adhesive capsulitis. Recent research suggests that cytokines and connective tissue growth factor (CTGF) may be involved in the inflammatory and fibrotic processes. The second purpose of this study involves histological and immunohistochemical analysis of capsular and synovial tissue routinely removed during an arthroscopic capsulectomy. Tissue taken from subjects in the surgical treatment group will be compared to tissue from patients undergoing an arthroscopic capsulectomy for reasons other than adhesive capsulitis (control group). Location and concentration of CTGF will be compared between these groups. If levels of CTGF are elevated in the treatment group as hypothesized, development and testing of agents that specifically reduce the action of CTGF may be indicated. A specific agent blocking CTGF has been developed and is nearing clinical trials.

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
None

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

入选标准

  • frozen shoulder (pain and stiffness) experienced for at least four months and treatment has not helped.

排除标准

  • 未提供

结局指标

主要结局

At the end of two years, the SPADI test, Range of Motion test and Strength test will be used to determine the effect of the intervention.

时间窗: 2 years

次要结局

  • The SPADI, Range of Motion and Strength test will be taken at six weeks, three months, six months, one year and two years to evaluate the condition of the affected shoulder.(6 wk, 3 mo, 6 mo, 1 yr, 2yr)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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