ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis (CAPSULITE)

January 3, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Rheumatology department of Lariboisiere hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
infiltration intra articular
Procedure: infiltration intra articular
infiltration intra articular at inclusion with XYLOCAINE 1%
Other Names:
  • infiltration intra articular at inclusion with XYLOCAINE 1%
EXPERIMENTAL: 2
ARTHRO distension plus intensive mobilisation
Procedure: ARTHRO distension plus intensive mobilisation
ARTHRO distension plus intensive mobilisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain and disability using SPADI score at 2 weeks
Time Frame: at 2 weeks
at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Johann Beaudreuil, PH MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (ESTIMATE)

July 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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