Prevalence of Cervical Spinal Cord Signal Abnormalities and Determinants of Treatment Selection in Patients With Cervical Radicular Pain: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients With Cervical Radicular Pain
Patients With Cervical Radicular Pain
干预措施: Clinical and Cervical MRI Assessment (Diagnostic Test)
结局指标
主要结局
Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia
时间窗: 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.
次要结局
- Planned Treatment Strategy(At the initial clinical evaluation (baseline))
- Clinical and Radiological Factors Associated With Interventional Treatment Selection(At the initial clinical evaluation (baseline))
- Association Between Hoffmann Sign and Cervical Spinal Cord Signal Abnormalities(At the initial clinical evaluation (baseline))
- Referral for Surgical Evaluation(At the initial clinical evaluation (baseline))
研究者
Ülkü Sabuncu
Assoc Prof
Ankara City Hospital Bilkent