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

History of Changes

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:

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

Contacts and Locations

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:

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.

Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4.

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. Review. No abstract available.

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.

Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.

Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71. No abstract available.

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.

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
Bursitis
Pathological Conditions, Anatomical
Joint Diseases
Musculoskeletal Diseases
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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