ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Shoulder Capsulitis Clinical Trial

— CAPSULITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724113
• Other study ID #: P051039
• 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

• Periarthritis
• Rheumatic Diseases
• Shoulder Capsulitis

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