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

NCT ID: NCT02001740

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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lidocaine

frequency = once

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type OTHER

receive once

Triamcinalone (steroid) and lidocaine

frequency = once

Group Type EXPERIMENTAL

Triamcinalone (steroid) and lidocaine

Intervention Type DRUG

receive once

Interventions

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Triamcinalone (steroid) and lidocaine

receive once

Intervention Type DRUG

Lidocaine

receive once

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ryan Bicknell

Assistant Professor, Queen's University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Bicknell, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

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Kingston General and Hotel Dieu Hospitals

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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SURG-246-12

Identifier Type: -

Identifier Source: org_study_id