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

NCT02001740 | Completed Phase 4

• 1 other identifier: SURG-246-12
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Keywords

shoulder

Outcome Measures

Primary Outcomes (1)

• functional outcomes as determined by the SPADI

  change in baseline at 1 year.

Secondary Outcomes (1)

• passive range of motion

  baseline, 3 and 6 and 12 week post injection.

Study Arms (2)

lidocaine

PLACEBO COMPARATOR

frequency = once

Other: Lidocaine

Triamcinalone (steroid) and lidocaine

EXPERIMENTAL

frequency = once

Drug: Triamcinalone (steroid) and lidocaine

Interventions

Triamcinalone (steroid) and lidocaine DRUG

receive once

Triamcinalone (steroid) and lidocaine

Lidocaine OTHER

receive once

lidocaine

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General and Hotel Dieu Hospitals

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Bursitis

Interventions

Steroids; Lidocaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ryan Bicknell, MD

  Queen's University and Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Queen's University.

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: December 5, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CA (1)