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

Completed

• Conditions: Human Cervical Motions

• Registration Number: NCT01186718
• Lead Sponsor: Michigan State University

Brief Summary

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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-28
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Cervical motion symmetry and asymmetry

Exclusion Criteria

• Under 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-D kinematic measurements of cervical motion	9/2009 to 8/2011

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States