We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Osteopathic Treatment in Adult Patients With Cystic Fibrosis (MUCOSTEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01293019
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Back Pain Neck Pain Chest Pain Procedure: Osteopathic treatment Procedure: Sham Placebo Procedure: Usual care Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study
Study Start Date : November 2009
Primary Completion Date : April 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental
Osteopathic treatment
Procedure: Osteopathic treatment
Real treatment of osteopathy
Other Name: Real treatment of osteopathy
Placebo Comparator: Placebo
Sham osteopathic treatment
Procedure: Sham Placebo
Sham treatment of osteopathy
Other Name: 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 Name: Classical treatment of pain in cystic fibrosis patients

Outcome Measures

Primary Outcome Measures :
  1. Pain score [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. quality of life scores [ Time Frame: at 6 months ]
  2. Co-interventions [ Time Frame: at 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293019

Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose
Study Chair: Dominique Hubert, MD Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01293019     History of Changes
Other Study ID Numbers: P 080701
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Complementary and alternative medicine
Osteopathic treatment

Additional relevant MeSH terms:
Back Pain
Cystic Fibrosis
Neck Pain
Chest Pain
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases