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Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

NCT ID: NCT00637299

Last Updated: 2011-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active osteopathic treatment (OMT+PR)

The examination was performed by osteopathic practitioners with emphasis on the neuromusculoskeletal system including palpatory diagnosis for somatic dysfunction and viscerosomatic change, in the context of total patient care. The examination was concerned with range of motion of all parts of the body, performed with the patient in multiple positions to provide static and dynamic evaluation.

Group Type ACTIVE_COMPARATOR

Active osteopathic treatment (OMT+PR): Active Comparator

Intervention Type OTHER

The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).

SOT + PR

Sham osteopathic treatment (manipulation)

Group Type SHAM_COMPARATOR

sham osteopathic treatment (SOT+PR)

Intervention Type OTHER

Only soft manipulation was performed

Interventions

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Active osteopathic treatment (OMT+PR): Active Comparator

The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).

Intervention Type OTHER

sham osteopathic treatment (SOT+PR)

Only soft manipulation was performed

Intervention Type OTHER

Other Intervention Names

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OMT+PR SOT+PR

Eligibility Criteria

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Inclusion Criteria

* patients affected by COPD

Exclusion Criteria

* other diseases other than COPD
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Salvatore Maugeri

OTHER

Sponsor Role lead

Responsible Party

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Ercole Zanotti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ercole Zanotti, md

Role: PRINCIPAL_INVESTIGATOR

Fondazione Salvatore Maugeri

Locations

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Fondazione Salvatore Maugeri

Montescano, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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01/2008

Identifier Type: -

Identifier Source: org_study_id