NCT01029600
Unknown
Not Applicable
Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
Bergen Surgical Hospital1 site in 1 country100 target enrollmentDecember 2009
ConditionsAdhesive Capsulitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adhesive Capsulitis
- Sponsor
- Bergen Surgical Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Shoulder Function
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.
Detailed Description
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up
- •The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder.
- •External rotation 20 degrees or less
- •Abduction 45 degrees or less
- •The patients must not be in phase 1 (inflammation phase)
- •Diabetics may be included
- •MRI must be taken to exclude other reasons for stiffness
Exclusion Criteria
- •Other reasons for stiffness( cuff rupture, arthritis)
- •Posttraumatic or postoperative stiffness
- •Patients not suited for day surgery
- •Patients with a history of subacromial impingement before developing stiffness
Outcomes
Primary Outcomes
Shoulder Function
Time Frame: 2 years
Secondary Outcomes
- Shoulder range of motion(2 years)
Study Sites (1)
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