Biomarkers of the Response to Osteopathic Manipulation

This study has been completed.
Sponsor:
Collaborator:
American Osteopathic Association
Information provided by:
West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT00958646
First received: August 12, 2009
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention
Healthy
Other: Osteopathic Manipulation
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment

Further study details as provided by West Virginia School of Osteopathic Medicine:

Primary Outcome Measures:
  • Salivary amylase levels [ Time Frame: baseline, 10 minutes post procedure ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00958646

Locations
United States, West Virginia
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States, 24901
Sponsors and Collaborators
West Virginia School of Osteopathic Medicine
American Osteopathic Association
Investigators
Principal Investigator: Kristie G Bridges, PhD West Virginia School of Osteopathic Medicine
  More Information

No publications provided

Responsible Party: Kristie Grove Bridges, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT00958646     History of Changes
Other Study ID Numbers: KB081209, 09-12-580
Study First Received: August 12, 2009
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia School of Osteopathic Medicine:
OMT
biomarker
Manipulation, osteopathic

ClinicalTrials.gov processed this record on August 28, 2014