Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics

November 28, 2011 updated by: Joseph Vorro, Michigan State University

Three-dimensional Study of Cervical Kinematics

The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern changes that result from osteopathic manipulation treatment (OMT) in an experimental subject group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D motion trajectories of the head, resulting in range of motion (ROM) and angular data for the primary and secondary motions.

Study Overview

Status

Completed

Conditions

Detailed Description

Our primary hypothesis is that kinematic changes will be detected after OMT for motions in the primary direction of the passive diagnostic test motions (cervical side-bending right and left), as well as angular rotations (deviations) occurring around these motions. Our secondary hypothesis is that examination of the kinematic data will provide objective inter- and intra-examiner data to assess similarities/differences occurring during the passive clinical exam before and after OMT. Lastly, we hypothesize that significant differences in the kinematic patterns will result between the two subject groups.

This experiment is designed for the following clinical and biomechanical observations:

  • comparisons of diagnostic data between three osteopathic physicians,
  • comparisons of within-subject kinematic profiles pre- and post-treatment,
  • inter-examiner comparisons of kinematic motion paths occurring during diagnostic motions,
  • evaluate kinematic patterns between the two subject groups, and assess between group similarities/differences,
  • evaluate diagnostic and kinematic data relative to VAS, cervical disability, health status information, and SNF,
  • re-classify aspects of the kinematic data using a cluster (statistical) analysis procedure to compare with initial and secondary physician diagnostic data, and
  • to assess the stability of changes made by the OMT procedures and the kinematic response three days post-treatment.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Two study groups: Control = subjects with symmetric cervical motion; Experimental = subjects with asymmetric cervical motion.

Description

Inclusion Criteria:

  • Cervical motion symmetry and asymmetry

Exclusion Criteria:

  • Under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
Control group = functional symmetric cervical motion.
Experimental subject group
Experimental subject group = asymmetric cervical motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-D kinematic measurements of cervical motion
Time Frame: 9/2009 to 8/2011
9/2009 to 8/2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

American Osteopathic Association

Investigators

  • Principal Investigator: Joseph Vorro, Phd, Michigan State University Dept. Family Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (ESTIMATE)

August 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AOA 09-05-581

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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