Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02030145
• Other study ID #: AOA Grant #06-04-545
• Secondary ID: 06-04-545
• Status: Withdrawn
• Phase: N/A
• First received: July 22, 2011
• Last updated: January 7, 2014
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary goal of this line of research is to see if realistic manipulative protocols can be developed to produce sustained reductions in residual volume and improve pulmonary function parameters in people with Chronic Obstructive Pulmonary Disease (COPD).

Description:

This study is a prospective randomized crossover study to evaluate the effects of two different manipulation techniques on pulmonary function parameters in persons with COPD. Thirty-six (36) subjects will be enrolled in the study in order to complete the study with at least 30 subjects. Pulmonary function measures will include spirometry and lung volume. The pulmonary function testing will be done baseline, 30 minutes post-treatment, and 3 hours post-treatment. The study protocol treatment consists of a five-minute treatment session of one of the two studied treatment techniques given in a random order. After a washout period of at least four weeks, the subject will return for a second treatment session using the other technique.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:All subjects must be age 50 or older, have a history consistent with the diagnosis of COPD, and have documented airflow obstruction and an increased residual volume on pulmonary function testing. Airflow obstruction is defined as an FEV1/FVC ratio of 70 percent or less of the predicted value and a RV of 120 percent or greater of the predicted value.

Exclusion Criteria:Subjects will be excluded if they have received any form of manipulative treatment in the 3 months prior to enrolling in the study. Subjects with acute respiratory illness, such as an exacerbation of COPD, acute bronchitis, or pneumonia will be excluded from the study. Persons unable to cooperate and follow instructions to complete pulmonary function testing due to dementia or other cognitive disorders will be excluded as will persons with spinal scoliosis greater than 25 degrees, significant chest wall deformity, and acute rib or compression fracture of the vertebra, unstable angina, or unstable congestive heart failure.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Compressive Thoracic Lymphatic Pump
This technique is a modification of the Classic Thoracic Lymphatic Pump where some pressure is maintained on the chest wall at the end of each exhalation and at the end of the third or fourth breathing cycle, during the inhalation phase, the hands are slowly removed from the chest wall, gradually releasing pressure on the chest without causing a sudden change in intrathoracic pressures.
• Classic Thoracic Lymphatic Pump
This technique is well described in Chapter 68 of the Foundations for Osteopathic Medicine, 2nd Edition.

Locations

Country	Name	City	State
United States	A.T. Still University of Health Sciences	Kirksville	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences	American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function tests	Tests will be conducted by body plethysmography utilizing the MedGraphics® 1085 Series™ to measure changes in pulmonary function.	30 minutes and 3 hours post-treatment	No