Osteopathic Treatment in Adult Patients With Cystic Fibrosis (MUCOSTEO)

November 16, 2012 updated by: Assistance Publique - Hôpitaux de Paris

Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study

To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.

Study Type

Interventional

Enrollment (Actual)

32

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, 75014
        • Cochin 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 :

  • Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene
  • Age > 18 years
  • Patient with chronic chest , neck or back pain
  • Written Informed Consent
  • with health insurance

Exclusion criteria :

  • regular follow-up by an osteopathic physician in the previous 3 months
  • patients awaiting lung transplantation
  • history of lung transplantation
  • pregnancy
  • understanding disorders preventing the patient to apply the study
  • participation in another clinical interventional study protocol

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Osteopathic treatment
Procedure: Osteopathic treatment
Real treatment of osteopathy
Other Names:
  • Real treatment of osteopathy
Placebo Comparator: Placebo
Sham osteopathic treatment
Procedure: Sham Placebo
Sham treatment of osteopathy
Other Names:
  • Sham treatment of osteopathy
Active Comparator: Usual care
Classic treatment of cystic fibrosis patients
Procedure: Usual care
Classical treatment of pain in cystic fibrosis patients
Other Names:
  • Classical treatment of pain in cystic fibrosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain score
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life scores
Time Frame: at 6 months
at 6 months
Co-interventions
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Vaincre la Mucoviscidose

Investigators

  • Study Chair: Dominique Hubert, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

November 16, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 080701

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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