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Osteopathic Treatment in Adult Patients With Cystic Fibrosis

NCT ID: NCT01293019

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cystic Fibrosis Back Pain Neck Pain Chest Pain

Keywords

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Complementary and alternative medicine Osteopathic treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental

Osteopathic treatment

Group Type EXPERIMENTAL

Osteopathic treatment

Intervention Type PROCEDURE

Real treatment of osteopathy

Placebo

Sham osteopathic treatment

Group Type PLACEBO_COMPARATOR

Sham Placebo

Intervention Type PROCEDURE

Sham treatment of osteopathy

Usual care

Classic treatment of cystic fibrosis patients

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

Classical treatment of pain in cystic fibrosis patients

Interventions

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Osteopathic treatment

Real treatment of osteopathy

Intervention Type PROCEDURE

Sham Placebo

Sham treatment of osteopathy

Intervention Type PROCEDURE

Usual care

Classical treatment of pain in cystic fibrosis patients

Intervention Type PROCEDURE

Other Intervention Names

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Real treatment of osteopathy Sham treatment of osteopathy Classical treatment of pain in cystic fibrosis patients

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vaincre la Mucoviscidose

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique Hubert, MD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

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Cochin Hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25029347 (View on PubMed)

Other Identifiers

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P 080701

Identifier Type: -

Identifier Source: org_study_id