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MUCOSTEO: Osteopathic Treatment in Adult Patients With Cystic Fibrosis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01293019
Collaborator
Vaincre la Mucoviscidose (Other)
32
Enrollment
1
Location
3
Arms
25
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Nov 1, 2009
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain score [at 6 months]

    Secondary Outcome Measures

    1. quality of life scores [at 6 months]

    2. Co-interventions [at 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Cochin Hospital Paris France 75014

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • Vaincre la Mucoviscidose

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT01293019
    Other Study ID Numbers:
    • P 080701
    First Posted:
    Feb 10, 2011
    Last Update Posted:
    Nov 19, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Complementary and alternative medicine
    Osteopathic treatment
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis
    Neck Pain
    Chest Pain

    Study Results

    No Results Posted as of Nov 19, 2012