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NCT Number: NCT07823426

Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain

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.

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Key information

Conditions

Cervical Radiculopathy Central Nervous System Diseases Cervical Myelomalacia Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Spinal Cord Compression Spinal Cord Diseases Spinal Cord Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, 06680, Turkey (Türkiye)

Location contact

Ülkü Sabuncu, Assoc Prof

CONTACT

[email protected]

90312 5526000 ext. 102-103

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Completion of standardized neurological examination at the initial visit
  • Ability and willingness to provide written informed consent

Exclusion criteria

  • Previous cervical spine surgery
  • Acute cervical spine trauma
  • Known cervical spinal malignancy
  • Active spinal infection
  • Known inflammatory, demyelinating, or other non-degenerative spinal cord disease
  • Severe cognitive impairment or communication difficulty preventing reliable clinical assessment
  • Inadequate or non-diagnostic cervical MRI quality
  • Refusal to participate

Treatment and study plan

Clinical and Cervical MRI Assessment

Diagnostic Test

Participants 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.

Primary outcomes

  1. Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia

    Time frame: At the initial clinical evaluation (baseline)

    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.

Secondary outcomes

  1. Planned Treatment Strategy

    Time frame: At the initial clinical evaluation (baseline)

    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.

  2. Clinical and Radiological Factors Associated With Interventional Treatment Selection

    Time frame: At the initial clinical evaluation (baseline)

    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.

  3. Association Between Hoffmann Sign and Cervical Spinal Cord Signal Abnormalities

    Time frame: At the initial clinical evaluation (baseline)

    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.

  4. Referral for Surgical Evaluation

    Time frame: At the initial clinical evaluation (baseline)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ülkü Sabuncu, Assoc prof

CONTACT

[email protected]

905337085212

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Prevalence of Cervical Spinal Cord Signal Abnormalities and Determinants of Treatment Selection in Patients With Cervical Radicular Pain: A Prospective Cohort Study

Acronym: CSCS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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