drugset / Trial / NCT02001740

An RCT in Treatment of Adhesive Capsulitis Arthrographic Joint Distention With Local Anesthetic Alone

NCT02001740

Phase 4 Completed 108 enrolled Queen's University
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2012-12
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinalone Small molecule
Background Lidocaine Other / unclassified

Indications