ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Phase 3

Completed

• Conditions: Shoulder Capsulitis
• Interventions: Procedure: ARTHRO distension plus intensive mobilisation; Procedure: infiltration intra articular

• Registration Number: NCT00724113
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Study Start: 2009-02
• Primary Completion: 2013-08
• Status Verified: 2014-05
• Study Completion: 2014-07
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• age ≥ 18 years
• shoulder capsulitis
• duration of symptoms ≥ 3 months
• health insurance

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Exclusion Criteria

• cognitive disorders
• Hypo coagulation
• biological inflammatory syndrome
• uncontrolled diabetes
• XYLOCAINE allergy
• pregnancy
• unable to understand and to speak french
• previous surgery of shoulder
• shoulder infiltration or distension in the previous month
• local contraindication to shoulder infiltration

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ARTHRO distension plus intensive mobilisation	ARTHRO distension plus intensive mobilisation
1	infiltration intra articular	infiltration intra articular

Primary Outcome Measures

Name	Time	Method
Pain and disability using SPADI score at 2 weeks	at 2 weeks

Trial Locations

Locations (1)

Rheumatology department of Lariboisiere hospital; 🇫🇷 Paris, France