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
  Purpose

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


Condition Intervention
Adhesive Capsulitis
Procedure: Arthroscopic capsular release
Procedure: Distention with steroid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study

Further study details as provided by Bergen Surgical Hospital:

Primary Outcome Measures:
  • Shoulder Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder range of motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Publications:
Responsible Party: Dr. Ove Kr. Austgulen, Bergen Surgical Hospital
ClinicalTrials.gov Identifier: NCT01029600     History of Changes
Other Study ID Numbers: 2009/870
Study First Received: December 9, 2009
Last Updated: December 15, 2009
Health Authority: Norway: Ethics Committee

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

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014