NCT00742989

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2005

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
Last Updated

August 28, 2008

Status Verified

August 1, 2008

Enrollment Period

2 months

First QC Date

August 26, 2008

Last Update Submit

August 27, 2008

Conditions

Keywords

osteopathiclymphatictreatmentOLTnormal

Outcome Measures

Primary Outcomes (1)

  • Baseline blood pressure

    15 minute

Secondary Outcomes (1)

  • Plasma proteins

    15 minute

Study Arms (2)

A

EXPERIMENTAL

OLT administration

Other: OLT maneuver

B

SHAM COMPARATOR

placebo-OLT

Other: Sham OLT

Interventions

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

A

Therapeutic massage performed

B

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal, healthy volunteers
  • Males
  • Age 20 to 40 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dybedal Clinical Research Center, Kansas City University of Medicine and Biosciences

Kansas City, Missouri, 64106, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • W. Evan Rivers, DO

    Kansas City University of Medicine and Biosciences

    PRINCIPAL INVESTIGATOR
  • Charlott L. Williiams, RN, CCRC

    Kansas City University of Medicine and Biosciences

    STUDY DIRECTOR
  • Alan G. Glaros, PhD

    KCUMB

    STUDY DIRECTOR
  • Kevin Treffer, DO

    KCUMB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

May 1, 2005

Primary Completion

July 1, 2005

Study Completion

July 1, 2006

Last Updated

August 28, 2008

Record last verified: 2008-08

Locations