Physiotherapy and Capsulitis

April 19, 2016 updated by: Hopital Foch

Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis

Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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
      • Suresnes, France, 92150
        • Hopital Foch

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary idiopathic phase 2 capsulitis
  • Diagnosis of capsulitis confirmed by shoulder dilatation
  • Patients between 18 and 70 years of age
  • Exclusion Criteria:
  • Secondary capsulitis
  • Shoulder pain of other etiology
  • Cognitive disorders
  • Patients less than 18 years, and more than 70 years of age

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self rehabilitation
Other: Self rehabilitation
Experimental: Self rehabilitation plus physiotherapy
Other: Self rehabilitation plus physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Function of the shoulder joint (Score de Constant)
Time Frame: 12 months post shoulder dilatation
12 months post shoulder dilatation

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain Visual Analogue Scale (at evening, rest, and at movement)
Time Frame: 12 months post shoulder dilatation
12 months post shoulder dilatation

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

  • Study Chair: Bernard BOISAUBERT, MD, Hôpital FOCH 40, rue Worth 92150 Suresnes
  • Principal Investigator: Louis FRANCESCHI, MD, IMM - 42, boulevard Jourdan 75014 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

April 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/03

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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