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

NCT02001740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2015-11-24

No results posted yet for this study

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.

Conditions

  • Adhesive Capsulitis

Interventions

DRUG

Triamcinalone (steroid) and lidocaine

receive once

OTHER

Lidocaine

receive once

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • Ryan Bicknell, MD · Queen's University and Kingston General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001740 on ClinicalTrials.gov