Osteopathic Treatment in Adult Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— MUCOSTEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293019
• Other study ID #: P 080701
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2011
• Last updated: November 16, 2012
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chest Pain
• Cystic Fibrosis
• Fibrosis
• Neck Pain

Intervention

Procedure:
• Osteopathic treatment
Real treatment of osteopathy
• Sham Placebo
Sham treatment of osteopathy
• Usual care
Classical treatment of pain in cystic fibrosis patients

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Vaincre la Mucoviscidose

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score		at 6 months	No
Secondary	quality of life scores		at 6 months	No
Secondary	Co-interventions		at 6 months	No