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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Bergen Surgical Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Haraldsplass Deaconess Hospital
Haukeland University Hospital
Information provided by:
Bergen Surgical Hospital
ClinicalTrials.gov Identifier:
NCT01029600
First received: December 9, 2009
Last updated: December 15, 2009
Last verified: December 2009

December 9, 2009
December 15, 2009
December 2009
March 2012   (final data collection date for primary outcome measure)
Shoulder Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029600 on ClinicalTrials.gov Archive Site
Shoulder range of motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?
Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study

The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Adhesive Capsulitis
  • Procedure: Arthroscopic capsular release
    Surgical division of thickened capsule in the shoulder
  • Procedure: Distention with steroid
    Intraarticular distention with steroid, saline, contrast and local anaesthetic
  • Active Comparator: Arthroscopic Capsulotomy
    Arthroscopic capsular release
    Intervention: Procedure: Arthroscopic capsular release
  • Active Comparator: Distention with steroid
    Arthrographic distention with contrast, saline, steroid and local anaesthetic
    Intervention: Procedure: Distention with steroid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Ove K Austgulen, MD +4793232026 ovaust@gmail.com
Contact: Jannike Øyen, M Sc
Norway
 
NCT01029600
2009/870
No
Dr. Ove Kr. Austgulen, Bergen Surgical Hospital
Bergen Surgical Hospital
  • Haraldsplass Deaconess Hospital
  • Haukeland University Hospital
Study Chair: Eirik J Solheim, MD, PhD University of Bergen, Surgical Dept.
Study Director: Leiv Hove, MD, PhD University of Bergen, Surgical Dept.
Bergen Surgical Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP