The Correlation of Myodural Bridges to Biomechanical Parameters in Patients Suffering From Primary Chronic Neck Pain

May 20, 2015 updated by: Hillel Yaffe Medical Center
In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. The physiologic function of these fibers is still unknown. Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers undergo changes in patients suffering from primary chronic neck pain. In addition, the biomechanical parameters of neck movements in these patients will be correlated with the imaging findings.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from Primary Chronic Neck Pain who have undergone MRI. Healthy volunteers who have undergone MRI of the cervical spine.

Description

Inclusion Criteria:

  • Chronic Neck Pain

Exclusion Criteria:

  • Have undergone cervical spine surgery
  • Known cerebral vascular disease of the carotid or vertebral arteries
  • Malignant disease of the cervical spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Chronic Neck Pain
Patients suffering for at least 3 years from neck pain without any underlying pathology who have undergone MRI. Biomechanical parameters of neck movements will be investigated.
MRI of cervical spine
Control
Patients without neck pain who have undergone MRI for any reason. Biomechanical parameters of neck movements will be investigated.
MRI of cervical spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume and Number of Muscle Fibers in Myodural Bridges
Time Frame: One hour
A composite outcome including the interpretation, counting and measurement of muscle fibers as found on MRI
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of cervical range of motion
Time Frame: Two hours
Measurements will be made using a cervical range of motion device (CROM Device)
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yaron River, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0034-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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