Osteopathic Treatment in Adult Patients With Cystic Fibrosis (MUCOSTEO)

This study has been completed.
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01293019
First received: February 9, 2011
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pain score [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life scores [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
  • Co-interventions [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293019

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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: February 9, 2011
Last Updated: November 16, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 19, 2014