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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2009

Last Updated Date

July 12, 2011

Start Date ^ICMJE

August 2009

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00958646 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biomarkers of the Response to Osteopathic Manipulation

Official Title ^ICMJE

Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Other: Osteopathic Manipulation
Standardized rib raising protocol
Other: Placebo
Light touch control procedure

Study Arm (s)

Experimental: Osteopathic Manipulation
Standardized OMT procedure

Intervention: Other: Osteopathic Manipulation
Placebo Comparator: Placebo
Light touch placebo procedure

Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00958646

Other Study ID Numbers ^ICMJE

KB081209, 09-12-580

Has Data Monitoring Committee

Responsible Party

Kristie Grove Bridges, West Virginia School of Osteopathic Medicine

Study Sponsor ^ICMJE

West Virginia School of Osteopathic Medicine

Collaborators ^ICMJE

American Osteopathic Association

Investigators ^ICMJE

Principal Investigator:

Kristie G Bridges, PhD

West Virginia School of Osteopathic Medicine

Information Provided By

West Virginia School of Osteopathic Medicine

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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