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临床试验/NCT06410222
NCT06410222Enrolling By Invitation不适用

Risk Factor Analysis and Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Short-course Spinal Cord Electrical Stimulation: a Multicenter, Retrospective, Observational Study

Feng Gao1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
300
试验地点
1
主要终点
Pain recurrence

研究概览

简要总结

Shingles is a neuropathic disease caused by varicella-herpes virus(VZV) invading nerves and accompanying pain.Currently, the treatment of postherpetic neuralgia (PHN) includes medication and minimally invasive interventional therapy.In patients with herpes zoster neuralgia treated with spinal cord stimulation (SCS), some patients have satisfactory pain relief after surgery, but some patients have pain symptoms again some time after surgery. The reason for this difference in treatment effect is not clear.

详细描述

Shingles is a neuropathic disease caused by varicella-herpes virus(VZV) invading nerves and accompanying pain. About 3~5/1000 people suffer from shingles every year in the world, and 2.9~5.8/1000 people over the age of 50 in China suffer from shingles every year, with an annual growth rate of 2.5~5.0%. If acute herpes zoster can not be treated effectively, it will be transformed into postherpetic neuralgia (PHN), patients will suffer long-term knife, needle, burning pain as well as hyperalgesia, touch induced pain and skin paresthesia, which seriously affect the daily life of patients. It also causes a huge social and economic burden.Currently, the treatment of postherpetic neuralgia (PHN) includes medication and minimally invasive interventional therapy. The European Neurological Association has proposed guidelines for first - and second-line drug treatment of herpes zoster neuralgia with level A evidence. At the same time, some patients are relieved by interventional therapy, such as injection therapy (local injection, peripheral nerve block, stellar ganglion block), nerve stimulation therapy (percutaneous electrical nerve stimulation, peripheral nerve stimulation, pulsed radiofrequency), spinal cord stimulation (SCS), and spinal dorsal horn ganglion destruction.

In 1976, spinal cord stimulation (SCS) was first used to treat patients with nociceptive pain. It is to place the stimulation electrode around the diseased nerve for a certain time, frequency, and voltage adjustment, so as to relieve pain. At present, spinal cord stimulation (SCS) has been widely used and studied in the treatment of postherpetic neuralgia (PHN) at home and abroad, and its mechanism of action may be related to the "gate control theory of pain" : in the dorsal horn of the spinal cord, α fiber can inhibit the pain signal transmitted by C fiber, and spinal cord stimulation (SCS) may regulate the transmission of pain signal through this mechanism. At the same time, spinal cord stimulation (SCS) can also affect the levels of gamma-aminobutyric acid and adenosine in the dorsal horn, thereby reducing neuropathic pain.In patients with herpes zoster neuralgia treated with spinal cord stimulation (SCS), some patients have satisfactory pain relief after surgery, but some patients have pain symptoms again some time after surgery. The reason for this difference in treatment effect is not clear. Therefore, this study intends to retrospectively analyze the clinical data of patients with and the risk factors for recurrence after treatment, and then construct a prognostic prediction model to provide evidence and reference for clinical treatment of postherpetic neuralgia (PHN).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Age ≥18 years old.
  • •NRS score ≥4 points.
  • •The pain NRS of previous shingles area treated with SCS was ≤3, and the pain NRS was > 4 after recurrence.

排除标准

  • •Serious cardiovascular and cerebrovascular diseases, such as heart failure, intracranial aneurysm, hypertension (high risk, very high risk).
  • •Epilepsy, suffering from mental illness.
  • •And patients who were lost to follow-up.

结局指标

主要结局

Pain recurrence

时间窗: up to 1 year

The diagnostic criteria for pain recurrence at the site of postherpetic neuralgia were Numeric Rating Scales(NRS) score \> 4.

次要结局

  • Surgical safety indicators(after the surgery 3 days)
  • Albumin(Day 1 in the hospital)
  • systolic blood pressure(Day 1 in the hospital)
  • numeric rating scale(NRS)(the day before the spinal cord stimulation surgical)
  • eosinophilic granulocyte(Day 1 in the hospital)
  • red blood cell count(Day 1 in the hospital)
  • C-reactive protein(Day 1 in the hospital)
  • diastolic blood pressure(Day 1 in the hospital)
  • hemoglobin(Day 1 in the hospital)
  • The time of electrodes placed in patients(immediately after the surgery)
  • erythrocyte sedimentation rate (ESR)(Day 1 in the hospital)
  • neutrophilic granulocyte percentage(Day 1 in the hospital)

研究者

发起方
Feng Gao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Gao

Professor

Tongji Hospital

研究点 (1)

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