Interexaminer Reliability, Outcomes for Manipulation of C... | NCT01186718

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

NCT01186718

Sponsor

Michigan State University

Status

Completed

Last Update Posted

Nov 29, 2011Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Human Cervical Motions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 20, 2010

First Submission Date that Met QC Criteria

Aug 20, 2010

First Posted Date

Aug 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2011

Last Update Posted Date

Nov 29, 2011Estimated

Name	Class
American Osteopathic Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		Control group = functional symmetric cervical motion.
Experimental subject group		Experimental subject group = asymmetric cervical motion

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cervical motion symmetry and asymmetry

Exclusion Criteria:

Under 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Vorro, Phd	Michigan State University Dept. Family Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michigan State University		East Lansing	Michigan	48824	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23509819	Derived	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.