跳至主要内容
临床试验/CTRI/2025/04/085400
CTRI/2025/04/085400尚未招募不适用

To evaluate the effectiveness of conservative treatment in patients with cervical disc prolapse.

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
VAS score

研究概览

简要总结

Neck pain represents a significant global public health concern, with a wide range of etiologies. Among the various causes, cervical prolapsed intervertebral discs are one of the most prevalent contributors. Cervical disc prolapse arises when the nucleus pulposus, the inner gel-like component of the intervertebral disc, herniates and exerts pressure on the cervical spinal cord or nerve roots. This compression can lead to a range of neurological symptoms. The incidence of cervical disc herniation is approximately 1.79 per 1000 individuals per year , with the highest frequency observed in individuals during the fourth or fifth decade of life. Clinically, patients typically present with symptoms such as neck pain, arm pain, and sensory deficits, which often correspond to the dermatome of the affected cervical nerve root(s) .

Although there is a lack of universally accepted diagnostic criteria for cervical radiculopathy , the diagnosis is primarily established through a combination of clinical examination, patient history, and imaging, particularly magnetic resonance imaging (MRI). MRI serves as a valuable diagnostic tool, aiding in the visualization of disc herniation and the extent of nerve root or spinal cord involvement.

Treatment for cervical disc prolapse typically begins with conservative management, which includes pharmacological interventions, physical therapy, immobilization, cervical traction, and epidural steroid injections. In cases where conservative treatment fails to provide relief or in the presence of significant neurological deficits, myelopathy, or radiological evidence of spinal cord injury, surgical intervention may be indicated. Surgical options may include discectomy, fusion, or more advanced procedures, depending on the severity and location of the disc herniation. Further studies are needed to refine diagnostic criteria, optimize conservative treatment protocols, and evaluate long-term outcomes associated with both non-surgical and surgical management.

There is limited literature concerning the duration of conservative therapy for cervical disc prolapse, largely due to the unclear natural history of this condition. In our study, we aim to evaluate the efficacy of conservative treatment in patients diagnosed with cervical disc prolapse.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age – 18 – 60 years 2.Presence of neck pain and radicular symptoms of a minimum duration of 1 month.
  • 3.Diagnosis of cervical disc prolapse with associated nerve root compression, as confirmed by magnetic resonance imaging (MRI), corresponding to the clinical presentation of radicular symptoms.

排除标准

  • 1.Presence of neurological impairments or clinical evidence of myelopathy.
  • 2.A documented history of prior cervical spine surgery.
  • 3.Individuals demonstrating neurological deficits.
  • 4.Individuals with a history of neuropsychiatric conditions.
  • 5.Individuals with a history of traumatic injury to the cervical spine.
  • 6.Individuals with significant comorbidities that may interfere with treatment outcomes (e.g., severe osteoporosis, malignancies, or systemic inflammatory disorders).

结局指标

主要结局

VAS score

时间窗: Visits at 3 months,6 months and 12 months

Kernofsky performance score

时间窗: Visits at 3 months,6 months and 12 months

NDI score

时间窗: Visits at 3 months,6 months and 12 months

次要结局

未报告次要终点

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验