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

Phase 4

Completed

• Conditions: Adhesive Capsulitis
• Interventions: Other: Lidocaine; Drug: Triamcinalone (steroid) and lidocaine

• Registration Number: NCT02001740
• Lead Sponsor: Queen's University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-11-28
• Study First Posted: 2013-12-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-21
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine	Lidocaine	frequency = once
Triamcinalone (steroid) and lidocaine	Triamcinalone (steroid) and lidocaine	frequency = once

Primary Outcome Measures

Name	Time	Method
functional outcomes as determined by the SPADI	change in baseline at 1 year.

Secondary Outcome Measures

Name	Time	Method
passive range of motion	baseline, 3 and 6 and 12 week post injection.

Trial Locations

Locations (1)

Kingston General and Hotel Dieu Hospitals; 🇨🇦 Kingston, Ontario, Canada