Overview

This trial is active, not recruiting.

Condition shoulder capsulitis
Treatments infiltration intra articular, arthro distension plus intensive mobilisation
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date February 2009
End date August 2013
Trial size 66 participants
Trial identifier NCT00724113, P051039

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
infiltration intra articular
infiltration intra articular infiltration intra articular at inclusion with XYLOCAINE 1%
infiltration intra articular at inclusion with XYLOCAINE 1%
(Experimental)
ARTHRO distension plus intensive mobilisation
arthro distension plus intensive mobilisation ARTHRO distension plus intensive mobilisation
ARTHRO distension plus intensive mobilisation

Primary Outcomes

Measure
Pain and disability using SPADI score at 2 weeks
time frame: at 2 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - age ≥ 18 years - shoulder capsulitis - duration of symptoms ≥ 3 months - health insurance 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

Additional Information

Official title Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
Principal investigator Johann Beaudreuil, PH MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.