Human Cervical MotionsNCT01186718
Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics
An observational study of Human Cervical Motions, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Cervical Motions
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two study groups: Control = subjects with symmetric cervical motion; Experimental = subjects with asymmetric cervical motion.
Who may be able to join
- Cervical motion symmetry and asymmetry
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Three-dimensional Study of Cervical Kinematics
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.
Read the 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.
- Conditions
- Human Cervical Motions
- Keywords
- Cervical, motions, kinematics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Control group = functional symmetric cervical motion. | |
| Experimental subject group | Experimental subject group = asymmetric cervical motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-D kinematic measurements of cervical motion
Measured: 9/2009 to 8/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Cervical MotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Principal investigator, Joseph Vorro, Michigan State University
- Investigators
- Joseph Vorro, Phd, Principal investigator, Michigan State University Dept. Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186718
- Sponsor's protocol ID
- AOA 09-05-581
- Status last verified
- Nov 2011
- First submitted
- 20 Aug 2010
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23509819
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Study of Cervical Kinematics
- ClinicalTrials.gov ID
- NCT01186718
- Acronym / sponsor ID
- AOA 09-05-581
- Conditions
- Human Cervical Motions
- Keywords
- Cervical, motions, kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Control group = functional symmetric cervical motion. |
| Experimental subject group | – | –Experimental subject group = asymmetric cervical motion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two study groups: Control = subjects with symmetric cervical motion; Experimental = subjects with asymmetric cervical motion.
Key inclusion criteria (1 listed)
- Cervical motion symmetry and asymmetry
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-D kinematic measurements of cervical motion
Time frame: 9/2009 to 8/2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
- Derived from this study: PubMed 23509819Vorro 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Vorro, Phd principal investigator
Michigan State University Dept. Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Cervical Motions, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-D kinematic measurements of cervical motion (time frame: 9/2009 to 8/2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.