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

Primary Purpose

Adhesive Capsulitis

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Triamcinalone (steroid) and lidocaine

Lidocaine

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring shoulder

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kingston General and Hotel Dieu Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

lidocaine

Triamcinalone (steroid) and lidocaine

Arm Description

frequency = once

Outcomes

Primary Outcome Measures

functional outcomes as determined by the SPADI

Secondary Outcome Measures

passive range of motion

Full Information

NCT ID

NCT02001740

First Posted

August 20, 2013

Last Updated

November 21, 2015

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT02001740

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adhesive Capsulitis

Keywords

shoulder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lidocaine

Arm Type

Placebo Comparator

Arm Description

frequency = once

Arm Title

Triamcinalone (steroid) and lidocaine

Arm Type

Experimental

Arm Description

frequency = once

Intervention Type

Drug

Intervention Name(s)

Triamcinalone (steroid) and lidocaine

Intervention Description

receive once

Intervention Type

Other

Intervention Name(s)

Lidocaine

Intervention Description

receive once

Primary Outcome Measure Information:

Title

functional outcomes as determined by the SPADI

Time Frame

change in baseline at 1 year.

Secondary Outcome Measure Information:

Title

passive range of motion

Time Frame

baseline, 3 and 6 and 12 week post injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Bicknell, MD

Organizational Affiliation

Queen's University and Kingston General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kingston General and Hotel Dieu Hospitals

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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