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Clinical Trials/NCT01029600
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

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
April 2012
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bergen Surgical Hospital

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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