ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01029600
Recruitment Status : Unknown
Verified December 2009 by Bergen Surgical Hospital.
Recruitment status was:  Recruiting
First Posted : December 10, 2009
Last Update Posted : December 16, 2009
Sponsor:
Collaborators:
Haraldsplass Deaconess Hospital
Haukeland University Hospital
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Procedure: Arthroscopic capsular release Procedure: Distention with steroid Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : April 2012

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



Primary Outcome Measures :
  1. Shoulder Function [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Shoulder range of motion [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029600


Contacts
Contact: Ove K Austgulen, MD +4793232026 ovaust@gmail.com
Contact: Jannike Øyen, M Sc

Locations
Norway
Haraldsplass Deaconess Hospital Recruiting
Bergen, Hordaland, Norway, 5009
Contact: Jesper Blomquist, MD    +4755978500    jblo@haraldsplass.no   
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.

Publications of Results:
Other Publications:
Responsible Party: Dr. Ove Kr. Austgulen, Bergen Surgical Hospital
ClinicalTrials.gov Identifier: NCT01029600     History of Changes
Other Study ID Numbers: 2009/870
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: December 2009

Keywords provided by Bergen Surgical Hospital:
Randomized study capsulotomy vs distention with steroid

Additional relevant MeSH terms:
Bursitis
Dilatation, Pathologic
Joint Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical