A Phase 3 interventional study of infiltration intra articular and ARTHRO distension plus intensive mobilisation in Shoulder Capsulitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's enrollment of 66 is above the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
infiltration intra articular
Procedure: infiltration intra articular
ARTHRO distension plus intensive mobilisation
Procedure: ARTHRO distension plus intensive mobilisation
infiltration intra articular at inclusion with XYLOCAINE 1%
Also known as: infiltration intra articular at inclusion with XYLOCAINE 1%
ARTHRO distension plus intensive mobilisation
Pain and disability using SPADI score at 2 weeks
Time frame: at 2 weeks
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris