Clinical trial NCT01029600: Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?
Official title: Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Randomized study capsulotomy vs distention with steroid
Lead sponsor: Bergen Surgical Hospital
Sponsor class: OTHER
Collaborators: name: Haraldsplass Deaconess Hospital
name: Haukeland University Hospital
First posted: 2009-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Function
timeFrame: 2 years
Secondary outcomes:
measure: Shoulder range of motion
timeFrame: 2 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconess Hospital
state: Hordaland
Study officials:
affiliation: University of Bergen, Surgical Dept.
name: Eirik J Solheim, MD, PhD
role: STUDY_CHAIR
affiliation: University of Bergen, Surgical Dept.
name: Leiv Hove, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.
citation: 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.
citation: 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.
citation: Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
citation: Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255.
citation: 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.
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.
citation: Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
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.
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. doi: 10.1093/rheumatology/25.2.147.
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.