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The Efficacy of High-frequency Short-time Spinal Cord Stimulation in the Treatment of Herpes Zoster-associated Neuralgia

Recruitingn/aAges 40 Years - 85 YearsAllLi Zhao
NCT06942806 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Zoster-associated neuralgia (ZAN) is a type of neuropathic pain caused by the reactivation of the varicella-zoster virus (VZV). The global annual incidence is approximately 3-5 per 1,000 individuals, and in China, the incidence is around 4.89 per 1,000 individuals, increasing with age. The underlying mechanisms of ZAN involve neuroinflammation, peripheral and central sensitization, and other factors, ultimately leading to anxiety, depression, and significant reductions in quality of life. Treating ZAN remains challenging. Spinal cord stimulation (SCS) alleviates pain via multiple mechanisms, including the gate control theory, modulation of neurotransmitters (e.g., gamma-aminobutyric acid), suppression of neuroinflammation (e.g., reduced levels of IL-1ฮฒ and TNF-ฮฑ), and promotion of autophagy. However, traditional low-frequency SCS (30-100 Hz) is limited by incomplete pain coverage, reduc

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients with inadequate response to non-surgical treatments such as pharmacotherapy; 2. Patients with major organ dysfunction intolerant to drug therapy; 3. Patients with systemic comorbidities (e.g., hypertension, diabetes mellitus); 4. Patients with moderate to severe pain intensity (Numerical Rating Scale \[NRS\] score โ‰ฅ 4). Exclusion Criteria: 1. Patients with severe psychiatric disorders; 2. Patients with severe local or systemic infections at the puncture site; 3. Patients with severe coagulopathies (platelet count \< 80ร—10โน/L during puncture) or those requiring uninterrupted anticoagulation therapy without bridging protocol; 4. Patients with end-stage organ failure who cannot maintain prone positioning or tolerate the procedure; 5. Patients with severe spinal stenosis, vertebral ankylosis, or scoliosis; 6. Patients with language barrier or impaired communication abilities.ion
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What it tests

  • HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 ฮผs, amplitude 0.5-3.0 V
  • LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 ฮผs, amplitude 0.5-5.0 V
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Where

1 site
149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province
Zunyi, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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