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Cervical Radiculopathy Imaging Using MRN With Electrodiagnostic Correlation

ConditionCervical Radiculopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorHospital for Special Surgery, New York

About this trial

This project will study patients with cervical radiculopathy. We will evaluate the combined diagnostic and prognostic value of magnetic resonance neurography (MRN), electrodiagnostic (EDX) studies, and historical and physical clinical elements. Specifically, this project will explore whether these data individually or in combination correlate with response to procedural and non-procedural treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients presenting with symptoms compatible with acute or subacute unilateral (one-sided) cervical radiculopathy and signs of clinical weakness

18-60 years old at the time of evaluation

Symptom onset of 2 to 12 weeks leading up to baseline visit

Diagnosis of unilateral cervical radiculopathy, with or without spinal cord compression, based on signs and symptoms, physical exam and supported by MRI findings of radiculopathy (as evidenced by foraminal stenosis/narrowing) based on standard-of-care cervical spine MRI

Disqualifiers

Prior cervical surgery or instrumentation

Those who have had a prior episode of cervical radiculopathy

History of peripheral neuropathy or another acute or chronic neurodegenerative condition

History of stroke, cerebellar disease, or central nervous system disease

Trial population

Patients with acute or subacute unilateral cervical radiculopathy and signs of clinical weakness

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic resonance neurography

    Diagnostic test

    Patients will undergo a cervical MRI with specialized magnetic resonance neurography sequences to evaluate the extraforaminal cervical nerve roots.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Cervical Radiculopathy Patients1 intervention

Trial outcomes

Primary outcomes

1

Presence of abnormalities on nerve (MRN) imaging

Presence of abnormalities on cervical MRN imaging that correspond to clinical findings of cervical radiculopathy. This includes abnormalities in extraforaminal cervical nerve root intraneural T2 signal and DTI values.

Time frame
Baseline
2

Relationship between abnormalities on imaging and electrodiagnostic assessment

The relationship between any abnormalities identified on nerve imaging (cervical MRN) and electrodiagnostic findings will be assessed.

Time frame
Baseline

Secondary outcomes

1

Numeric rating scale (NRS) pain

Current NRS pain will be assessed on 0-10 scales (10=worst pain).

Time frame
Baseline, 3 months, 6 months, 12 months
2

Neck Disability Index (NDI)

NDI is scored on a 0-100% scale, with 100% representing complete disability.

Time frame
Baseline, 3 months, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Source ClinicalTrials.gov
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