NCT01293019

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 19, 2012

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

February 9, 2011

Last Update Submit

November 16, 2012

Conditions

Cystic FibrosisBack PainNeck PainChest Pain

Keywords

Complementary and alternative medicineOsteopathic treatment

Outcome Measures

Primary Outcomes (1)

  • Pain score

    at 6 months

Secondary Outcomes (2)

  • quality of life scores

    at 6 months

  • Co-interventions

    at 6 months

Study Arms (3)

Experimental

EXPERIMENTAL

Osteopathic treatment

Procedure: Osteopathic treatment

Placebo

PLACEBO COMPARATOR

Sham osteopathic treatment

Procedure: Sham Placebo

Usual care

ACTIVE COMPARATOR

Classic treatment of cystic fibrosis patients

Procedure: Usual care

Interventions

Osteopathic treatmentPROCEDURE

Real treatment of osteopathy

Also known as: Real treatment of osteopathy
Experimental
Sham PlaceboPROCEDURE

Sham treatment of osteopathy

Also known as: Sham treatment of osteopathy
Placebo
Usual carePROCEDURE

Classical treatment of pain in cystic fibrosis patients

Also known as: Classical treatment of pain in cystic fibrosis patients
Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 25029347DERIVED

MeSH Terms

Conditions

Cystic FibrosisBack PainNeck PainChest Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Dominique Hubert, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

December 1, 2011

Last Updated

November 19, 2012

Record last verified: 2012-11

Locations

FR(1)