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临床试验/NCT02001740
NCT02001740已完成4 期

Treatment of Adhesive Capsulitis: A Randomized Placebo-Controlled Trial Comparing Arthrographic Joint Distention With Steroid and Local Anesthetic Versus Arthrographic Joint Distention With Local Anesthetic Alone

Queen's University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
108
试验地点
1
主要终点
functional outcomes as determined by the SPADI

研究概览

简要总结

Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.

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
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range 19-70
  • Female and male
  • Ability to understand and give consent
  • Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.

排除标准

  • • Frozen shoulder secondary to trauma
  • Previous surgery on the affected shoulder
  • Age less than 19 or greater than 70
  • Systemic inflammatory joint disease such as Rheumatoid Arthritis
  • Radiographic evidence of osteoarthritis of the shoulder
  • Allergy to contrast material
  • Pregnant or breastfeeding women

研究组 & 干预措施

lidocaine

Placebo Comparator

frequency = once

干预措施: Lidocaine (Other)

Triamcinalone (steroid) and lidocaine

Experimental

frequency = once

干预措施: Triamcinalone (steroid) and lidocaine (Drug)

结局指标

主要结局

functional outcomes as determined by the SPADI

时间窗: change in baseline at 1 year.

次要结局

  • passive range of motion(baseline, 3 and 6 and 12 week post injection.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ryan Bicknell

Assistant Professor, Queen's University.

Queen's University

研究点 (1)

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