Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration. - Full Text View

Sponsored by:	Kansas City University of Medicine and Biosciences
Information provided by:	Kansas City University of Medicine and Biosciences
ClinicalTrials.gov Identifier:	NCT00742989

Purpose

The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes an increase in plasma volume, total plasma protein concentration, and albumin concentration. This is an important step in understanding the effects of OLT, specifically its effects on fluid in the body. The primary role of the lymph system is the return of fluid and proteins lost from the blood vessels. Despite this, no research has been done to see what effects an OLT has on fluid and protein levels in the blood.

Condition	Intervention
Healthy Volunteers	Other: OLT maneuver Other: Sham OLT

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Crossover Assignment
Official Title:	The Short-Term Effect of Osteopathic Lymphatic Treatment on Blood Cell Count, Plasma Protein, and Blood Pressure: A Pilot Study in a Cross-Over Design

Further study details as provided by Kansas City University of Medicine and Biosciences:

Primary Outcome Measures:

Baseline blood pressure [ Time Frame: 15 minute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma proteins [ Time Frame: 15 minute ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	May 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental OLT administration	Other: OLT maneuver direct myofascial release for the thoracic inlet for 30 seconds, supine rib raising for 1 minute on each side of the body, thoracic pumping for one minute, thoracic vacuum for 30 seconds, doming of the abdominal diaphragm for 30 seconds, abdominal pumping for 1 minute, pedal pumping for 1 minute, a second thoracic pump for 1 minute, a second thoracic vacuum for 30 seconds, and a final direct myofascial release for the thoracic inlet lasting 30 seconds
B: Sham Comparator placebo-OLT	Other: Sham OLT Therapeutic massage performed

Arms

Assigned Interventions

A: Experimental

OLT administration

Other: OLT maneuver

direct myofascial release for the thoracic inlet for 30 seconds, supine rib raising for 1 minute on each side of the body, thoracic pumping for one minute, thoracic vacuum for 30 seconds, doming of the abdominal diaphragm for 30 seconds, abdominal pumping for 1 minute, pedal pumping for 1 minute, a second thoracic pump for 1 minute, a second thoracic vacuum for 30 seconds, and a final direct myofascial release for the thoracic inlet lasting 30 seconds

B: Sham Comparator

placebo-OLT

Other: Sham OLT

Therapeutic massage performed

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal, healthy volunteers
Males
Age 20 to 40 years

Exclusion Criteria:

History of cardiovascular, kidney, or liver disease.
Cannot have taken medication or drugs or have been ill at the time of the study or for two weeks prior.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742989

Locations

United States, Missouri
Dybedal Clinical Research Center, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, United States, 64106

Sponsors and Collaborators

Kansas City University of Medicine and Biosciences

Investigators

Principal Investigator:	W. Evan Rivers, DO	Kansas City University of Medicine and Biosciences
Study Director:	Charlott L. Williiams, RN, CCRC	Kansas City University of Medicine and Biosciences
Study Director:	Alan G. Glaros, PhD	KCUMB
Study Chair:	Kevin Treffer, DO	KCUMB

More Information

Dybedal Clinical Research Center This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Rivers WE, Treffer KD, Glaros AG, Williams CL. Short-term hematologic and hemodynamic effects of osteopathic lymphatic techniques: a pilot crossover trial. J Am Osteopath Assoc. 2008 Nov;108(11):646-51.

Responsible Party:	Kansas City University of Medicine and Biosciences ( Patrick G. Clay, PharmD, Director, Dybedal Center for Clinical Research )
Study ID Numbers:	KCUMB-2005-01
Study First Received:	August 26, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00742989
Health Authority:	United States: Institutional Review Board

Keywords provided by Kansas City University of Medicine and Biosciences:

osteopathic
lymphatic
treatment
OLT
normal

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009