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NCT00742989 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00742989
Other study ID # KCUMB-2005-01
Secondary ID
Status Completed
Phase N/A
First received August 26, 2008
Last updated August 27, 2008
Start date May 2005
Est. completion date July 2006

Study information
Verified date August 2008
Source Kansas City University of Medicine and Biosciences
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2006
Est. primary completion date July 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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 OLT
Therapeutic massage performed

Locations
Country Name City State
United States Dybedal Clinical Research Center, Kansas City University of Medicine and Biosciences Kansas City Missouri

Sponsors (1)
Lead Sponsor Collaborator
Kansas City University of Medicine and Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline blood pressure 15 minute No
Secondary Plasma proteins 15 minute No
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