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

NCT01029600 | Unknown

• 1 other identifier: 2009/870
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adhesive Capsulitis

Keywords

Randomized study capsulotomy vs distention with steroid

Outcome Measures

Primary Outcomes (1)

• Shoulder Function

  2 years

Secondary Outcomes (1)

• Shoulder range of motion

  2 years

Study Arms (2)

Arthroscopic Capsulotomy

ACTIVE COMPARATOR

Arthroscopic capsular release

Procedure: Arthroscopic capsular release

Distention with steroid

ACTIVE COMPARATOR

Arthrographic distention with contrast, saline, steroid and local anaesthetic

Procedure: Distention with steroid

Interventions

Arthroscopic capsular release PROCEDURE

Surgical division of thickened capsule in the shoulder

Arthroscopic Capsulotomy

Distention with steroid PROCEDURE

Intraarticular distention with steroid, saline, contrast and local anaesthetic

Distention with steroid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bergen Surgical Hospital: lead
• Haraldsplass Deaconess Hospital: collaborator
• Haukeland University Hospital: collaborator

Study Sites (1)

Haraldsplass Deaconess Hospital

Bergen, Hordaland, 5009, Norway

RECRUITING

Related Publications (11)

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

  BACKGROUND

• 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.

  PMID: 5008469 BACKGROUND

• 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.

  PMID: 2436441 BACKGROUND

• Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.

  PMID: 670287 RESULT

• Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255.

  PMID: 1198072 RESULT

• 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.

  PMID: 6742896 RESULT

• 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.

  RESULT

• Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.

  PMID: 16356983 RESULT

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

  PMID: 1624489 RESULT

• 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.

  PMID: 3708230 RESULT

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

  PMID: 7559688 RESULT

MeSH Terms

Conditions

Bursitis

Interventions

Joint Capsule Release; Dilatation; Steroids

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Investigative Techniques; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Eirik J Solheim, MD, PhD

  University of Bergen, Surgical Dept.

  STUDY CHAIR

• Leiv Hove, MD, PhD

  University of Bergen, Surgical Dept.

  STUDY DIRECTOR

Central Study Contacts

Ove K Austgulen, MD

CONTACT

+4793232026; ovaust@gmail.com

Jannike Øyen, M Sc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 16, 2009

Record last verified: 2009-12

Locations

NO (1)