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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186718
First Posted: August 23, 2010
Last Update Posted: November 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Osteopathic Association
Information provided by (Responsible Party):
Joseph Vorro, Michigan State University
  Purpose
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.

Condition
Human Cervical Motions

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Three-dimensional Study of Cervical Kinematics

Further study details as provided by Joseph Vorro, Michigan State University:

Primary Outcome Measures:
  • 3-D kinematic measurements of cervical motion [ Time Frame: 9/2009 to 8/2011 ]

Enrollment: 30
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Group
Control group = functional symmetric cervical motion.
Experimental subject group
Experimental subject group = asymmetric cervical motion

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Two study groups: Control = subjects with symmetric cervical motion; Experimental = subjects with asymmetric cervical motion.
Criteria

Inclusion Criteria:

  • Cervical motion symmetry and asymmetry

Exclusion Criteria:

  • Under 18 years of age
  Contacts and Locations
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): NCT01186718


Locations
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
American Osteopathic Association
Investigators
Principal Investigator: Joseph Vorro, Phd Michigan State University Dept. Family Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Vorro, Professor and PI, Michigan State University
ClinicalTrials.gov Identifier: NCT01186718     History of Changes
Other Study ID Numbers: AOA 09-05-581
First Submitted: August 20, 2010
First Posted: August 23, 2010
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Joseph Vorro, Michigan State University:
Cervical, motions, kinematics