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The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.
The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | infiltration intra articular |
|
| 2 | Experimental | ARTHRO distension plus intensive mobilisation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infiltration intra articular | Procedure | infiltration intra articular at inclusion with XYLOCAINE 1% |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain and disability using SPADI score at 2 weeks | at 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johann Beaudreuil, PH MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology department of Lariboisiere hospital | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38824872 | Derived | Jacob L, Lasbleiz S, Sanchez K, Morchoisne O, Lefevre-Colau MM, Nguyen C, Rannou F, Feydy A, Portal JJ, Schnitzler A, Vicaut E, Laredo JD, Richette P, Orcel P, Beaudreuil J. Arthro-distension with early and intensive mobilization for shoulder adhesive capsulitis: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Sep;67(6):101852. doi: 10.1016/j.rehab.2024.101852. Epub 2024 Jun 1. |
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| ARTHRO distension plus intensive mobilisation | Procedure | ARTHRO distension plus intensive mobilisation |
|