- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01029600
Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?
December 15, 2009 updated by: Bergen Surgical Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ove K Austgulen, MD
- Phone Number: +4793232026
- Email: ovaust@gmail.com
Study Contact Backup
- Name: Jannike Øyen, M Sc
Study Locations
-
-
Hordaland
-
Bergen, Hordaland, Norway, 5009
- Recruiting
- Haraldsplass Deaconess Hospital
-
Contact:
- Jesper Blomquist, MD
- Phone Number: +4755978500
- Email: jblo@haraldsplass.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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
- The patients must not be in phase 1 (inflammation phase)
- Diabetics may be included
- MRI must be taken to exclude other reasons for stiffness
Exclusion Criteria:
- Other reasons for stiffness( cuff rupture, arthritis)
- Posttraumatic or postoperative stiffness
- Patients not suited for day surgery
- Patients with a history of subacromial impingement before developing stiffness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arthroscopic Capsulotomy
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
|
Intraarticular distention with steroid, saline, contrast and local anaesthetic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder Function
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder range of motion
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.
- Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71. doi: 10.1136/ard.31.1.69. No abstract available.
- Moren-Hybbinette I, Moritz U, Schersten 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. doi: 10.1111/j.0954-6820.1987.tb01247.x.
- Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
- Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255.
- Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4. doi: 10.1136/ard.43.3.361.
- Duplay ES. De la periarthrite scapulo-humérale et des raideurs de l'épaule qui en sont la conséquence. Arch Gen Med 1872;20:513-42.
- Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
- Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.
- Pal B, Anderson J, Dick WC, Griffiths ID. Limitation of joint mobility and shoulder capsulitis in insulin- and non-insulin-dependent diabetes mellitus. Br J Rheumatol. 1986 May;25(2):147-51. doi: 10.1093/rheumatology/25.2.147.
- Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
March 1, 2012
Study Completion (Anticipated)
April 1, 2012
Study Registration Dates
First Submitted
December 9, 2009
First Submitted That Met QC Criteria
December 9, 2009
First Posted (Estimate)
December 10, 2009
Study Record Updates
Last Update Posted (Estimate)
December 16, 2009
Last Update Submitted That Met QC Criteria
December 15, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/870
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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