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

NCT ID: NCT01186718

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Human Cervical Motions

Keywords

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Cervical, motions, kinematics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control Group

Control group = functional symmetric cervical motion.

No interventions assigned to this group

Experimental subject group

Experimental subject group = asymmetric cervical motion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Cervical motion symmetry and asymmetry

Exclusion Criteria

* Under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Joseph Vorro

Professor and PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Vorro, Phd

Role: PRINCIPAL_INVESTIGATOR

Michigan State University Dept. Family Medicine

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23509819 (View on PubMed)

Other Identifiers

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AOA 09-05-581

Identifier Type: -

Identifier Source: org_study_id