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Osteopathic Treatment in Adult Patients With Cystic Fibrosis (MUCOSTEO)

Primary Purpose

Cystic Fibrosis, Back Pain, Neck Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Osteopathic treatment
Sham Placebo
Usual care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Complementary and alternative medicine, Osteopathic treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Experimental

Placebo

Usual care

Arm Description

Osteopathic treatment

Sham osteopathic treatment

Classic treatment of cystic fibrosis patients

Outcomes

Primary Outcome Measures

Pain score

Secondary Outcome Measures

quality of life scores
Co-interventions

Full Information

First Posted
February 9, 2011
Last Updated
November 16, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Vaincre la Mucoviscidose
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1. Study Identification

Unique Protocol Identification Number
NCT01293019
Brief Title
Osteopathic Treatment in Adult Patients With Cystic Fibrosis
Acronym
MUCOSTEO
Official Title
Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Vaincre la Mucoviscidose

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Back Pain, Neck Pain, Chest Pain
Keywords
Complementary and alternative medicine, Osteopathic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Osteopathic treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sham osteopathic treatment
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Classic treatment of cystic fibrosis patients
Intervention Type
Procedure
Intervention Name(s)
Osteopathic treatment
Other Intervention Name(s)
Real treatment of osteopathy
Intervention Description
Real treatment of osteopathy
Intervention Type
Procedure
Intervention Name(s)
Sham Placebo
Other Intervention Name(s)
Sham treatment of osteopathy
Intervention Description
Sham treatment of osteopathy
Intervention Type
Procedure
Intervention Name(s)
Usual care
Other Intervention Name(s)
Classical treatment of pain in cystic fibrosis patients
Intervention Description
Classical treatment of pain in cystic fibrosis patients
Primary Outcome Measure Information:
Title
Pain score
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
quality of life scores
Time Frame
at 6 months
Title
Co-interventions
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hubert, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25029347
Citation
Hubert D, Soubeiran L, Gourmelon F, Grenet D, Serreau R, Perrodeau E, Zegarra-Parodi R, Boutron I. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study. PLoS One. 2014 Jul 16;9(7):e102465. doi: 10.1371/journal.pone.0102465. eCollection 2014.
Results Reference
derived

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Osteopathic Treatment in Adult Patients With Cystic Fibrosis

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