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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001740
• Other study ID #: SURG-246-12
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2013
• Last updated: November 21, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• • 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Triamcinalone (steroid) and lidocaine
receive once

Other:
• Lidocaine
receive once

Locations

Country	Name	City	State
Canada	Kingston General and Hotel Dieu Hospitals	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcomes as determined by the SPADI		change in baseline at 1 year.	No
Secondary	passive range of motion		baseline, 3 and 6 and 12 week post injection.	No