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临床试验/NCT07593313
NCT07593313招募中不适用

Efficacy and Safety of Short-Term Spinal Cord Stimulation Combined With Pharmacotherapy for Central Post-Stroke Pain: A Single-Center, Randomized, Controlled Trial

Nanchong Central Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1

研究概览

简要总结

To evaluate the short-term analgesic efficacy of stSCS combined with pharmacotherapy compared with pharmacotherapy alone in patients with CPSP, measured by Numerical Rating Scale (NRS) score immediately after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Diagnosis of central post-stroke pain (CPSP) according to the International Association for the Study of Pain (IASP) criteria
  • Clear history of stroke confirmed by cranial CT or MRI
  • Pain occurring after stroke and distributed in body parts corresponding to central nervous system injury
  • Pain with neuropathic characteristics (e.g., burning sensation, electric shock sensation, needle prick sensation)
  • Pain not explained by other causes
  • Age ≥ 18 years
  • Pain duration ≥ 3 months
  • Baseline pain Numerical Rating Scale (NRS) score ≥ 4 points
  • Complete clinical data with follow-up time ≥ 6 months

排除标准

  • History of chronic pain before stroke
  • Severe cognitive impairment that prevents cooperation with pain assessment (Mini-Mental State Examination, MMSE < 15 points)
  • Contraindications to spinal cord stimulation (SCS), such as coagulation disorders, active infections, or mental diseases that prevent cooperation
  • Malignant tumors or other severe organic diseases with expected survival < 1 year

研究者

发起方
Nanchong Central Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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