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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
History of Changes

February 9, 2011
November 16, 2012
November 2009
April 2011   (final data collection date for primary outcome measure)
Pain score [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Pain score [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01293019 on ClinicalTrials.gov Archive Site
  • 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 ]
  • quality of life scores [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Co-interventions [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Osteopathic Treatment in Adult Patients With Cystic Fibrosis
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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Back Pain
  • Neck Pain
  • Chest Pain
  • Procedure: Osteopathic treatment
    Real treatment of osteopathy
    Other Name: Real treatment of osteopathy
  • Procedure: Sham Placebo
    Sham treatment of osteopathy
    Other Name: Sham treatment of osteopathy
  • Procedure: Usual care
    Classical treatment of pain in cystic fibrosis patients
    Other Name: Classical treatment of pain in cystic fibrosis patients
  • Experimental: Experimental
    Osteopathic treatment
    Intervention: Procedure: Osteopathic treatment
  • Placebo Comparator: Placebo
    Sham osteopathic treatment
    Intervention: Procedure: Sham Placebo
  • Active Comparator: Usual care
    Classic treatment of cystic fibrosis patients
    Intervention: Procedure: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01293019
P 080701
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose
Study Chair: Dominique Hubert, MD AP-HP
Assistance Publique - Hôpitaux de Paris
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP