Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAnkara City Hospital Bilkent
About this trial
This prospective observational study aims to determine the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, among adult patients presenting to a tertiary pain clinic with cervical radicular pain.
A total of 400 consecutive patients will be enrolled. Clinical and neurological examination findings, including the Hoffmann sign and other findings suggestive of cervical spinal cord involvement, will be recorded together with cervical magnetic resonance imaging (MRI) findings obtained as part of routine clinical care.
The primary outcome is the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, on cervical MRI. Secondary outcomes include the treatment strategy selected during routine clinical care, clinical and radiological factors associated with treatment selection, the relationship between the Hoffmann sign and cervical spinal cord abnormalities, and referral for surgical evaluation.
This is an observational study. Participation in the study will not determine or alter diagnostic or treatment decisions, which will be made by the treating physician according to routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Presentation to the pain clinic with cervical radicular pain
Clinical symptoms and/or examination findings consistent with cervical nerve root involvement
Availability of a cervical magnetic resonance imaging (MRI) examination suitable for evaluation
Disqualifiers
Previous cervical spine surgery
Acute cervical spine trauma
Known cervical spinal malignancy
Active spinal infection
Trial population
The study population will consist of 400 consecutive adult patients presenting to the tertiary Pain Medicine Clinic of Ankara Bilkent City Hospital with cervical radicular pain. Participants will be prospectively enrolled during routine clinical evaluation. Clinical and neurological examination findings, cervical MRI characteristics, and the treatment strategy selected by the treating physician will be recorded. No diagnostic or therapeutic intervention will be assigned by the study protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical and Cervical MRI Assessment
Diagnostic testParticipants will undergo routine clinical and neurological evaluation, including assessment of the Hoffmann sign and other neurological findings, together with evaluation of cervical magnetic resonance imaging (MRI) findings. Cervical MRI findings, including spinal canal stenosis, spinal cord compression, intramedullary signal abnormalities, and myelomalacia, will be recorded. All assessments are performed as part of routine clinical care. No diagnostic procedure or treatment is assigned by the study protocol.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Patients With Cervical Radicular Pain1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia
The proportion of participants with cervical spinal cord signal abnormalities identified on cervical magnetic resonance imaging (MRI), including intramedullary T2-weighted signal abnormalities and findings consistent with myelomalacia, will be determined. The prevalence will be calculated as the number of participants with these MRI findings divided by the total number of enrolled participants with evaluable cervical MRI examinations.
Time frame
At the initial clinical evaluation (baseline)Secondary outcomes
1
Planned Treatment Strategy
The treatment strategy selected during routine clinical care will be recorded for each participant. Management will be categorized as interventional pain procedure, medical treatment without intervention, referral for surgical evaluation, or other clinically appropriate management.
Time frame
At the initial clinical evaluation (baseline)2
Clinical and Radiological Factors Associated With Interventional Treatment Selection
The association between predefined clinical and radiological variables and the decision to plan an interventional pain procedure will be evaluated. Variables will include Hoffmann sign, motor deficit, hyperreflexia, Babinski sign, clonus, gait abnormality, central canal stenosis, spinal cord compression, intramedullary signal abnormality, and myelomalacia.
Time frame
At the initial clinical evaluation (baseline)3
Association Between Hoffmann Sign and Cervical Spinal Cord Signal Abnormalities
The relationship between Hoffmann sign status and cervical spinal cord abnormalities on MRI will be evaluated. The frequency of spinal cord signal abnormalities and myelomalacia will be compared between participants with positive and negative Hoffmann signs.
Time frame
At the initial clinical evaluation (baseline)4
Referral for Surgical Evaluation
The proportion of participants referred for neurosurgical or spine surgical evaluation following clinical and radiological assessment will be determined, and factors associated with referral will be explored.
Time frame
At the initial clinical evaluation (baseline)Sponsors and contacts
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Source ClinicalTrials.gov
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