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

Adhesive Capsulitis Clinical Trial

Official title:

Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01029600
• Other study ID #: 2009/870
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2009
• Last updated: December 15, 2009
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: December 2009
• Source: Bergen Surgical Hospital
• Contact: Ove K Austgulen, MD
• Phone: +4793232026
• Email: ovaust[@]gmail.com
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis

Intervention

Procedure:
• Arthroscopic capsular release
Surgical division of thickened capsule in the shoulder
• Distention with steroid
Intraarticular distention with steroid, saline, contrast and local anaesthetic

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconess Hospital	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
Bergen Surgical Hospital	Haraldsplass Deaconess Hospital, Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (11)

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

Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71. — View Citation

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

Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.

Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. Review. — View Citation

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.

Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. — View Citation

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. — View Citation

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. — View Citation

Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. — View Citation

Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Function		2 years	No
Secondary	Shoulder range of motion		2 years	No