- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02452827
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
Intervention / Treatment
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.
Sponsor
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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