Effects of Osteopathic Techniques on Residual Volume in Severe Chronic Obstructive Pulmonary Disease

NCT02755363 | Unknown

• 1 other identifier: WarsawMU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the selected osteopathic techniques have a positive impact on the residual volume decrease in patients with chronic obstructive pulmonary disease with severe and very severe airflow limitation in comparison to the manual therapy not aimed to decrease hyperinflation (placebo).

Conditions

COPD

Keywords

COPD; residual volume; osteopathy; hyperinflation

Outcome Measures

Primary Outcomes (1)

• Lung function tests (mainly residual volume) before and after selected osteopathic techniques in patients with COPD (III, IV degree of airway obstruction according to GOLD).

  40 minutes

Study Arms (2)

osteopathic manual therapy (OMT group)

ACTIVE COMPARATOR

patients who will undergo manual osteopathic therapy.

Other: osteopathic manual therapy

control group (C group)

PLACEBO COMPARATOR

patients who will undergo manual therapy not aimed to decrease hyperinflation.

Other: control group

Interventions

osteopathic manual therapy OTHER

* suboccipital decompression - atlanto-occipital joint relaxation technique. * deep cervical fascia release - the technique aims to improve mobility of the first and second ribs during expiration and to relaxation of the vagus and phrenic nerve course area. * thoracic lymphatic pump with activation is designed to reduce the tension of mediastinal structures, improve lymphatic flow, and thus reduce the breathing resistance. * stretching the diaphragm in order to relax and reduce adhesion within the fascial system between the diaphragm and abdominal organs.

osteopathic manual therapy (OMT group)

control group OTHER

* manual mobilization techniques of the slides in the shoulder joint toward the front, rear and bottom. * manual techniques to increase range of motion in the shoulder joints using the patient's breathing manoeuvres.

control group (C group)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a clinical diagnosis of COPD in accordance with GOLD,
• post-bronchodilator FEV1 \< 50% of predicted value,
• smoking history of ≥ 10 pack-years,
• the ability to remain in supine position for at least 25 minutes.

You may not qualify if:

• exacerbation in the past 6 weeks,

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Departament of Internal Medicine, Pneumonology and Allergology, Warsaw Medical University

Warsaw, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Katarzyna Górska, PhD, MD

  WMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Górska, PhD, MD

CONTACT

+48501077180; drkpgorska@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)