NCT02452827

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

May 18, 2015

Last Update Submit

May 20, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Volume and Number of Muscle Fibers in Myodural Bridges

    A composite outcome including the interpretation, counting and measurement of muscle fibers as found on MRI

    One hour

Secondary Outcomes (1)

  • Measurement of cervical range of motion

    Two hours

Study Arms (2)

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.

Other: Biomechanical parametersOther: MRI

Control

Patients without neck pain who have undergone MRI for any reason. Biomechanical parameters of neck movements will be investigated.

Other: Biomechanical parametersOther: MRI

Interventions

ControlPrimary Chronic Neck Pain
MRIOTHER

MRI of cervical spine

ControlPrimary Chronic Neck Pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Chronic Neck Pain

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yaron River, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Eden Afgin, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 25, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations