Clinical trial NCT01186718: Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics
Official title: Three-dimensional Study of Cervical Kinematics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Cervical Motions
Keywords: Cervical, motions, kinematics
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2010-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Two study groups: Control = subjects with symmetric cervical motion; Experimental = subjects with asymmetric cervical motion.

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.

Eligibility criteria: Inclusion Criteria:

* Cervical motion symmetry and asymmetry

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: 3-D kinematic measurements of cervical motion
timeFrame: 9/2009 to 8/2011
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University Dept. Family Medicine
name: Joseph Vorro, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vorro J, Bush TR, Rutledge B, Li M. Kinematic measures during a clinical diagnostic technique for human neck disorder: inter- and intraexaminer comparisons. Biomed Res Int. 2013;2013:950719. doi: 10.1155/2013/950719. Epub 2013 Feb 16.