NCT00958646

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 13, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

August 12, 2009

Last Update Submit

July 12, 2011

Conditions

Healthy

Keywords

OMTbiomarkerManipulation, osteopathic

Outcome Measures

Primary Outcomes (1)

  • Salivary amylase levels

    baseline, 10 minutes post procedure

Study Arms (2)

Osteopathic Manipulation

EXPERIMENTAL

Standardized OMT procedure

Other: Osteopathic Manipulation

Placebo

PLACEBO COMPARATOR

Light touch placebo procedure

Other: Placebo

Interventions

Osteopathic ManipulationOTHER

Standardized rib raising protocol

Osteopathic Manipulation
PlaceboOTHER

Light touch control procedure

Placebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults between the ages of 21 and 60

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia School of Osteopathic Medicine

Lewisburg, West Virginia, 24901, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kristie G Bridges, PhD

    West Virginia School of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

July 13, 2011

Record last verified: 2011-07

Locations

US(1)