NCT00724113

ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Shoulder Capsulitis

Interventions

Type	Name	Description
PROCEDURE	infiltration intra articular	infiltration intra articular at inclusion with XYLOCAINE 1%
PROCEDURE	ARTHRO distension plus intensive mobilisation	ARTHRO distension plus intensive mobilisation

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-08-01
• Completion: 2014-07-01
• First posted: 2008-07-29
• Last updated: 2017-01-04

Locations

1 site across 1 country: France