Biomarkers of the Response to Osteopathic Manipulation

July 12, 2011 updated by: West Virginia School of Osteopathic Medicine

Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment

The purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
    • West Virginia
      • Lewisburg, West Virginia, United States, 24901
        • West Virginia School of Osteopathic Medicine

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

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults between the ages of 21 and 60

Exclusion Criteria:

  • Eating or drinking anything but water or chewing gum within an hour of the appointment
  • Rib fracture
  • History of unstable cardiac arrhythmia or symptoms related to the chest cavity (difficulty breathing, chest pain)
  • Symptoms suggestive of bowel obstruction (abdominal bloating with pain, nausea and vomiting, diarrhea)
  • Pregnancy
  • History of Sjogren's Syndrome

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Osteopathic Manipulation
Standardized OMT procedure
Other: Osteopathic Manipulation
Standardized rib raising protocol
PLACEBO_COMPARATOR: Placebo
Light touch placebo procedure
Other: Placebo
Light touch control procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Salivary amylase levels
Time Frame: baseline, 10 minutes post procedure
baseline, 10 minutes post procedure

Collaborators and Investigators

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

Sponsor

West Virginia School of Osteopathic Medicine

Collaborators

American Osteopathic Association

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

August 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (ESTIMATE)

August 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2011

Last Update Submitted That Met QC Criteria

July 12, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KB081209
  • 09-12-580

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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