Biomarkers of the Response to Osteopathic Manipulation | NCT00958646

Studies
Biomarkers of the Response to Osteopathic Manipulation

NCT00958646

Sponsor

West Virginia School of Osteopathic Medicine

Status

Completed

Last Update Posted

Jul 13, 2011Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Osteopathic Manipulation
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
09-12-580

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 12, 2009

First Submission Date that Met QC Criteria

Aug 12, 2009

First Posted Date

Aug 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2011

Last Update Posted Date

Jul 13, 2011Estimated

Name	Class
American Osteopathic Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Osteopathic Manipulation	Experimental	Standardized OMT procedure	Other: Osteopathic Manipulation
Placebo	Placebo Comparator	Light touch placebo procedure	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Osteopathic Manipulation	Other	Standardized rib raising protocol	Osteopathic Manipulation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristie G Bridges, PhD	West Virginia School of Osteopathic Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West Virginia School of Osteopathic Medicine		Lewisburg	West Virginia	24901	United States

Intervention Browse Module

MeSH Terms

ID	Term
D026301	Manipulation, Osteopathic

Ancestor Terms

ID	Term
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities

Browse Leaves

Not provided

Browse Branches

Not provided