Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?

Not Applicable

• Conditions: Adhesive Capsulitis

• Registration Number: NCT01029600
• Lead Sponsor: Bergen Surgical Hospital

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.

Study Timeline

• Status Verified: 2009-12
• Study Start: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Last Update Submitted: 2009-12-15
• Last Update Posted: 2009-12-16
• Primary Completion: 2012-03
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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

2. 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

3. The patients must not be in phase 1 (inflammation phase)

4. Diabetics may be included

5. MRI must be taken to exclude other reasons for stiffness

Exclusion Criteria

1. Other reasons for stiffness( cuff rupture, arthritis)
2. Posttraumatic or postoperative stiffness
3. Patients not suited for day surgery
4. Patients with a history of subacromial impingement before developing stiffness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder Function	2 years

Secondary Outcome Measures

Name	Time	Method
Shoulder range of motion	2 years

Trial Locations

Locations (1)

Haraldsplass Deaconess Hospital; 🇳🇴 Bergen, Hordaland, Norway