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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00724113
Other study ID # P051039
Secondary ID
Status Completed
Phase Phase 3
First received April 9, 2008
Last updated January 3, 2017
Start date February 2009
Est. completion date July 2014

Study information

Verified date May 2014
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
infiltration intra articular
infiltration intra articular at inclusion with XYLOCAINE 1%
ARTHRO distension plus intensive mobilisation
ARTHRO distension plus intensive mobilisation

Locations

Country Name City State
France Rheumatology department of Lariboisiere hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain and disability using SPADI score at 2 weeks at 2 weeks No
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