Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.

August 27, 2008 updated by: Kansas City University of Medicine and Biosciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Sham Comparator: B
placebo-OLT
Other: Sham OLT
Therapeutic massage performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline blood pressure
Time Frame: 15 minute
15 minute

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma proteins
Time Frame: 15 minute
15 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KCUMB-2005-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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