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Clinical Trials/NCT01293019
NCT01293019CompletedPhase 3

Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study

Assistance Publique - Hôpitaux de Paris2 sites in 1 country32 target enrollmentStarted: November 5, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Pain score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Experimental

Experimental

Osteopathic treatment

Intervention: Osteopathic treatment (Procedure)

Placebo

Placebo Comparator

Sham osteopathic treatment

Intervention: Sham Placebo (Procedure)

Usual care

Active Comparator

Classic treatment of cystic fibrosis patients

Intervention: Usual care (Procedure)

Outcomes

Primary Outcomes

Pain score

Time Frame: at 6 months

Secondary Outcomes

  • quality of life scores(at 6 months)
  • Co-interventions(at 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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