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.

Study Overview

• Status: Unknown
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Procedure: Arthroscopic capsular release; Procedure: Distention with steroid

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

• Study Contact: Name: Ove K Austgulen, MD; Phone Number: +4793232026; Email: ovaust@gmail.com
• Study Contact Backup: Name: Jannike Øyen, M Sc

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5009
      • Recruiting
      • Haraldsplass Deaconess Hospital
      • Contact: Jesper Blomquist, MD; Phone Number: +4755978500; Email: jblo@haraldsplass.no

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Shoulder Function	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Shoulder range of motion	2 years

Collaborators and Investigators

• Sponsor: Bergen Surgical Hospital
• Collaborators: Haukeland University Hospital; Haraldsplass Deaconess 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 and helpful links

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

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

• Keywords: Randomized study capsulotomy vs distention with steroid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Dilatation, Pathologic; Bursitis
• Other Study ID Numbers: 2009/870