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

This study has been completed.
Sponsor:
Information provided by:
Kansas City University of Medicine and Biosciences
ClinicalTrials.gov Identifier:
NCT00742989
First received: August 26, 2008
Last updated: August 27, 2008
Last verified: August 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Kansas City University of Medicine and Biosciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick G. Clay, PharmD, Director, Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
ClinicalTrials.gov Identifier: NCT00742989     History of Changes
Other Study ID Numbers: KCUMB-2005-01
Study First Received: August 26, 2008
Last Updated: August 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Kansas City University of Medicine and Biosciences:
osteopathic
lymphatic
treatment
OLT
normal

ClinicalTrials.gov processed this record on August 28, 2014