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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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
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