跳至主要内容
临床试验/NCT06001359
NCT06001359招募中不适用

Functional Limitation, Pain, Disability and Quality of Life in Patients With Cervical Spondylotic Radiculopathy

Karabuk University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
Funcitonal disability

研究概览

简要总结

Radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region [1]. Pain is the initial symptom and cervical radiculopathy should be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory complaints and motor weakness. It is most commonly caused by spondylotic changes, such as cervical disc herniation and bony prominences in this area, leading to nerve root compression and inflammatory changes. Stenotic changes in the spine, which are often observed with aging, can cause nerve damage and compression in individuals, causing radicular pain. However, there is insufficient study in which the relationship between pain caused by cervical spondylotic radiculopathy caused by stenosis and functional disability, disability and quality of life due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive outcome scale that evaluates the functional limitation caused by radicular pain has also led to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly developed scale used to evaluate functional limitation associated with radicular pain. In this context, in this study, it was aimed to examine the relationship between pain, functional disability, disability and quality of life in patients with cervical spondylotic radiculopathy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years of age
  • with lateral-foraminal spinal stenosis in the cervical region
  • with or without neck pain consistent with the diagnosis obtained from magnetic resonance imaging
  • with unilateral root symptoms such as pain, numbness, weakness in the affected limb, and diagnosis based on MRI and computerized tomography

排除标准

  • signs of increased ventral pressure, such as ventral osteophytes, disc calcification, and ligament hypertrophy
  • severe neurological deficits, pregnant women, spinal malignancies,
  • those who had undergone cervical surgery in the last 12 months
  • and those who could not cooperate

结局指标

主要结局

Funcitonal disability

时间窗: baseline

The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation.

Disability

时间窗: baseline

Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living

Neck/Arm Pain

时间窗: baseline

A numeric rating scale will be used to evaluate neck and arm pain severity.

life quality

时间窗: baseline

The EuroQol Five-Dimensions - 3-Level (EQ-5D-3L) General Quality of Life Scale will used to evaluate the quality of life of individuals

Severity of stenosis

时间窗: baseline

The severity of stenosis will be evaluated with MRI.

次要结局

未报告次要终点

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aydın Sinan Apaydin

Doctor

Karabuk University

研究点 (1)

Loading locations...

相似试验