Osteopathic Treatment in Adult Patients With Cystic Fibrosis (MUCOSTEO)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Back Pain; Chest Pain; Cystic Fibrosis; Neck Pain

Treatments: Procedure: Sham Placebo; Procedure: Osteopathic treatment; Procedure: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01293019

P 080701

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 3 patient groups, including a placebo group

Experimental

Experimental group

Description:

Osteopathic treatment

Treatment:

Procedure: Osteopathic treatment

Placebo

Placebo Comparator group

Description:

Sham osteopathic treatment

Treatment:

Procedure: Sham Placebo

Usual care

Active Comparator group

Description:

Classic treatment of cystic fibrosis patients

Treatment:

Procedure: Usual care