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Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00724113
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 3
Start date February 2009
Completion date July 2014

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