Healthy VolunteersNCT00742989
Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.
A study testing OLT maneuver in people with Healthy Volunteers, run by Kansas City University of Medicine and Biosciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- OLT maneuver
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy volunteers
- Males
- Age 20 to 40 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dybedal Clinical Research Center, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, 64106
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- OLT maneuver, Sham OLT
- Keywords
- osteopathic, lymphatic, treatment, OLT, normal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLT maneuverOther
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 OLTOther
Therapeutic massage performed
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | OLT administration Receives: Other: OLT maneuver |
| B | Sham comparator | placebo-OLT Receives: Other: Sham OLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline blood pressure
Measured: 15 minute
Secondary outcomes (1)
Plasma proteins
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startMay 2005
- Primary completionJul 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City University of Medicine and Biosciences
- Sponsor type
- University, hospital or other
- Investigators
- W. Evan Rivers, DO, Principal investigator, Kansas City University of Medicine and BiosciencesCharlott L. Williiams, RN, CCRC, Study director, Kansas City University of Medicine and BiosciencesAlan G. Glaros, PhD, Study director, KCUMBKevin Treffer, DO, Study chair, KCUMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742989
- Sponsor's protocol ID
- KCUMB-2005-01
- Status last verified
- Aug 2008
- First submitted
- 26 Aug 2008
- Last updated
- 28 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19011227
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00742989
- Acronym / sponsor ID
- KCUMB-2005-01
- Conditions
- Healthy Volunteers
- Keywords
- osteopathic, lymphatic, treatment, OLT, normal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kansas City University of Medicine and BiosciencesUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: OLT maneuverOLT administration |
| B | Sham comparator | Other: Sham OLTplacebo-OLT |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal, healthy volunteers
- Males
- Age 20 to 40 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLT maneuverdirect 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 | Other | A |
| Sham OLTTherapeutic massage performed | Other | B |
Primary outcome
Baseline blood pressure
Time frame: 15 minute
1 secondary outcome
Plasma proteins
Time frame: 15 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2008.
- Derived from this study: PubMed 19011227Rivers 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Evan Rivers, DO principal investigator
Kansas City University of Medicine and Biosciences
Charlott L. Williiams, RN, CCRC study director
Kansas City University of Medicine and Biosciences
Alan G. Glaros, PhD study director
KCUMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLT maneuver in people with Healthy Volunteers, run by Kansas City University of Medicine and Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline blood pressure (time frame: 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2008.