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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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Arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. Most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. It is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone.
The purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthrographic distention + intra-articular corticosteroid | Experimental | Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline. |
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| Arthrographic distention | Active Comparator | Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline. |
|
| Intra-articular corticosteroid | Active Comparator | Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrographic distention | Procedure | Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain and disability index(SPADI) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain and disability index (SPADI) | weekly for a period of 3 months plus at follow-up (4 months and 12 months) | |
| Overall pain score | Universal pain scale | weekly for a period of 3 months, plus at follow-up (4 months and 12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rolf Symons, MD | Contact | +32(0)15/50.62.31 | rolf.symons@imelda.be |
| Name | Affiliation | Role |
|---|---|---|
| Rolf Symons, MD | Imeldaziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Bonheiden | Antwerpen | 2820 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1855018 | Background | Jacobs LG, Barton MA, Wallace WA, Ferrousis J, Dunn NA, Bossingham DH. Intra-articular distension and steroids in the management of capsulitis of the shoulder. BMJ. 1991 Jun 22;302(6791):1498-501. doi: 10.1136/bmj.302.6791.1498. | |
| 1562888 | Background | Corbeil V, Dussault RG, Leduc BE, Fleury J. [Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension]. Can Assoc Radiol J. 1992 Apr;43(2):127-30. French. |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Intra-articular corticosteroid Depo Medrol | Drug | Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension) |
|
| Range of motion |
| 4 weeks, 4 months and 12 months |
| 9855212 | Background | Gam AN, Schydlowsky P, Rossel I, Remvig L, Jensen EM. Treatment of "frozen shoulder" with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial. Scand J Rheumatol. 1998;27(6):425-30. doi: 10.1080/030097498442244. |
| 14962967 | Background | Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655. |
| 15695959 | Background | Khan AA, Mowla A, Shakoor MA, Rahman MR. Arthrographic distension of the shoulder joint in the management of frozen shoulder. Mymensingh Med J. 2005 Jan;14(1):67-70. |