Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?
NCT ID: NCT01029600
Last Updated: 2009-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-12-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arthroscopic Capsulotomy
Arthroscopic capsular release
Arthroscopic capsular release
Surgical division of thickened capsule in the shoulder
Distention with steroid
Arthrographic distention with contrast, saline, steroid and local anaesthetic
Distention with steroid
Intraarticular distention with steroid, saline, contrast and local anaesthetic
Interventions
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Arthroscopic capsular release
Surgical division of thickened capsule in the shoulder
Distention with steroid
Intraarticular distention with steroid, saline, contrast and local anaesthetic
Eligibility Criteria
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Inclusion Criteria
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
2. Posttraumatic or postoperative stiffness
3. Patients not suited for day surgery
4. Patients with a history of subacromial impingement before developing stiffness
18 Years
70 Years
ALL
No
Sponsors
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Haraldsplass Deaconess Hospital
OTHER
Haukeland University Hospital
OTHER
Bergen Surgical Hospital
OTHER
Responsible Party
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Bergen Surgical Hospital
Principal Investigators
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Eirik J Solheim, MD, PhD
Role: STUDY_CHAIR
University of Bergen, Surgical Dept.
Leiv Hove, MD, PhD
Role: STUDY_DIRECTOR
University of Bergen, Surgical Dept.
Locations
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Haraldsplass Deaconess Hospital
Bergen, Hordaland, Norway
Countries
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Central Contacts
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Jannike Øyen, M Sc
Role: CONTACT
Facility Contacts
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Jesper Blomquist, MD
Role: primary
References
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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.
Other Identifiers
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2009/870
Identifier Type: -
Identifier Source: org_study_id