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

• Sponsor: Bergen Surgical Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01029600
• Collaborator: Haraldsplass Deaconess Hospital (Other), Haukeland University Hospital (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adhesive Capsulitis	Procedure: Arthroscopic capsular release; Procedure: Distention with steroid	N/A

Detailed Description

Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
• Study Start Date: Dec 1, 2009
• Anticipated Primary Completion Date: Mar 1, 2012
• Anticipated Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arthroscopic Capsulotomy Arthroscopic capsular release	Procedure: Arthroscopic capsular release; Surgical division of thickened capsule in the shoulder
Active Comparator: Distention with steroid Arthrographic distention with contrast, saline, steroid and local anaesthetic	Procedure: Distention with steroid; Intraarticular distention with steroid, saline, contrast and local anaesthetic

Outcome Measures

Primary Outcome Measures

1. Shoulder Function [2 years]

Secondary Outcome Measures

1. Shoulder range of motion [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

2. Diabetics may be included

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haraldsplass Deaconess Hospital	Bergen	Hordaland	Norway	5009

Sponsors and Collaborators

• Bergen Surgical Hospital
• Haraldsplass Deaconess Hospital
• Haukeland University Hospital

Investigators

• Study Chair: Eirik J Solheim, MD, PhD, University of Bergen, Surgical Dept.
• Study Director: Leiv Hove, MD, PhD, University of Bergen, Surgical Dept.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71.
• Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.
• Morén-Hybbinette I, Moritz U, Scherstén B. The clinical picture of the painful diabetic shoulder--natural history, social consequences and analysis of concomitant hand syndrome. Acta Med Scand. 1987;221(1):73-82.

• ClinicalTrials.gov Identifier: NCT01029600
• Other Study ID Numbers: 2009/870
• First Posted: Dec 10, 2009
• Last Update Posted: Dec 16, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Randomized study capsulotomy vs distention with steroid
• Additional relevant MeSH terms: Bursitis; Dilatation, Pathologic

Study Results

No Results Posted as of Dec 16, 2009