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| Name | Class |
|---|---|
| Haraldsplass Deaconess Hospital | OTHER |
| Haukeland University Hospital | OTHER |
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The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic Capsulotomy | Active Comparator | Arthroscopic capsular release |
|
| Distention with steroid | Active Comparator | Arthrographic distention with contrast, saline, steroid and local anaesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic capsular release | Procedure | Surgical division of thickened capsule in the shoulder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Function | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder range of motion | 2 years |
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Inclusion Criteria:
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.
The patients must not be in phase 1 (inflammation phase)
Diabetics may be included
MRI must be taken to exclude other reasons for stiffness
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ove K Austgulen, MD | Contact | +4793232026 | ovaust@gmail.com | |
| Jannike Øyen, M Sc | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Eirik J Solheim, MD, PhD | University of Bergen, Surgical Dept. | Study Chair |
| Leiv Hove, MD, PhD | University of Bergen, Surgical Dept. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haraldsplass Deaconess Hospital | Recruiting | Bergen | Hordaland | 5009 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934. | ||
| 5008469 | 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. | |
| 2436441 |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D057913 | Joint Capsule Release |
| D004106 | Dilatation |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Distention with steroid | Procedure | Intraarticular distention with steroid, saline, contrast and local anaesthetic |
|
| 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. |
| 670287 | Result | Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available. |
| 1198072 | Result | Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255. |
| 6742896 | 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. |
| 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. |
| 16356983 | Result | Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453. |
| 1624489 | 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. |
| 3708230 | 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. |
| 7559688 | 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. |
| D019637 | Orthopedic Procedures |
| D008919 | Investigative Techniques |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |