Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

Early Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: sham osteopathic treatment (SOT+PR)

• Registration Number: NCT00637299
• Lead Sponsor: Fondazione Salvatore Maugeri

Brief Summary

The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary rehabilitation trial is able to improve the walking ability of COPD patients and if there is any influence on lung functionality.

Detailed Description

The investigators decided to perform an osteopathic manipulative treatment (OMT) in a population of COPD patients. OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Concerning the respiratory system, osteopathy considers a model that describes the interdependent functions among five body components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4: articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between the ilia. This model is the so called primary respiratory mechanism.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-17
• Primary Completion: 2008-07
• Study Completion: 2008-11
• Results First Submitted: 2009-01-05
• Results First Submitted QC: 2009-04-17
• Results First Posted: 2009-04-20
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-16
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients affected by COPD

Exclusion Criteria

• other diseases other than COPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOT + PR	sham osteopathic treatment (SOT+PR)	Sham osteopathic treatment (manipulation)

Primary Outcome Measures

Name	Time	Method
Walking Ability	4 weeks	6 minutes walking test (6MWT)

Secondary Outcome Measures

Name	Time	Method
Lung Function Test	4 weeks	residual volume (RV)

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri; 🇮🇹 Montescano, Pavia, Italy