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Biomarkers of the Response to Osteopathic Manipulation

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ClinicalTrials.gov Identifier: NCT00958646
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : July 13, 2011
Sponsor:
Collaborator:
American Osteopathic Association
Information provided by:
West Virginia School of Osteopathic Medicine

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

Condition or disease Intervention/treatment Phase
Healthy Other: Osteopathic Manipulation Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : December 2010

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




Primary Outcome Measures :
  1. Salivary amylase levels [ Time Frame: baseline, 10 minutes post procedure ]


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011

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