The Efficacy of High-frequency Short-time Spinal Cord Stimulation in the Treatment of Herpes Zoster-associated Neuralgia
Li Zhao
74 participants
Feb 1, 2024
OBSERVATIONAL
Conditions
Summary
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-1β and TNF-α), and promotion of autophagy. However, traditional low-frequency SCS (30-100 Hz) is limited by incomplete pain coverage, reduced long-term efficacy, and side effects such as paresthesia (e.g., tingling sensations). High-frequency SCS (HF-SCS, 1,000 Hz) offers pain relief without inducing paresthesia. Studies have suggested that it may be superior to traditional SCS. However, clinical data on the use of HF-SCS in ZAN are limited, and no such studies have been conducted in China. This study aims to compare the efficacy of short-term high-frequency (1 kHz) SCS with traditional low-frequency SCS in the treatment of ZAN. By evaluating outcomes such as pain relief (NRS scores), improvements in anxiety and depression (HADS), sleep quality (PSQI), patient-reported experience, and complication rates, this research seeks to assess the safety and efficacy of short-term HF-SCS, thereby potentially providing a novel therapeutic strategy for patients with ZAN.
Eligibility
Inclusion Criteria4
- Patients with inadequate response to non-surgical treatments such as pharmacotherapy;
- Patients with major organ dysfunction intolerant to drug therapy;
- Patients with systemic comorbidities (e.g., hypertension, diabetes mellitus);
- Patients with moderate to severe pain intensity (Numerical Rating Scale \[NRS\] score ≥ 4).
Exclusion Criteria6
- Patients with severe psychiatric disorders;
- Patients with severe local or systemic infections at the puncture site;
- Patients with severe coagulopathies (platelet count \< 80×10⁹/L during puncture) or those requiring uninterrupted anticoagulation therapy without bridging protocol;
- Patients with end-stage organ failure who cannot maintain prone positioning or tolerate the procedure;
- Patients with severe spinal stenosis, vertebral ankylosis, or scoliosis;
- Patients with language barrier or impaired communication abilities.ion
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Interventions
HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V
LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V
Locations(1)
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NCT06942806