An observational study in Herpes Zoster Pain, sponsored by Li Zhao. Recruiting at 1 site in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Li Zhao · Observational
Among 51 studies in Herpes Zoster with a site in China — 26 open to participants now, 31 under way, 3 of them phase 3. Herpes Zoster · China.
Among the 51 studies in Herpes Zoster with a site in China, this one is one of 9 that started in 2024, is one of 6 observational ones, reaches primary completion later than 2 of the 30 other live ones, and was the 32nd registered.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
Browse Herpes Zoster studies →26 of the 51 studies in Herpes Zoster with a site in China are open now. Recruiting first, the newest first:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Sites in China
Ages 40+ · Healthy volunteers
Jiangsu Province Centers for Disease Control and Prevention · Sites in China
Ages 40+ · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 40+ · Healthy volunteers
Beijing Tiantan Hospital · Sites in China
Ages 18+
Beijing Tiantan Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 11 · Phase 3 7 · Phase 4 6
First in 2011; this study’s year is marked. 9 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 74 is below the median of 290 across 42 observational studies indexed under Herpes Zoster.
Median enrollment 519 across the 45 interventional studies, 187 across the 6 observational. Of the 16 that completed or were terminated, 1 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 51 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Li Zhao as lead sponsor.
Li Zhao has 1 study filed under Herpes Zoster — fewer than ten, so there is no comparison to draw.
10 of the studies in Herpes Zoster with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06851832Ab&B Bio-tech Co., Ltd.JSClinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older | 2026-11-28 |
| NCT07099157Peking University Third HospitalEfficacy and Safety of Brivudine in the Treatment of Herpes Zoster | 2026-12-31 |
| NCT07361796Beijing Tiantan HospitalThe Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster | 2027-09-30 |
| NCT07378046Beijing Tiantan HospitalThe Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster | 2027-09-30 |
| NCT07378059Beijing Tiantan HospitalThe Analgesic Efficacy and Safety of Loxoprofen Sodium Patch in Patients With Herpes Zoster | 2027-09-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 51 studies in Herpes Zoster with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Zoster-associated neuralgia (ZAN) refers to neuropathic pain resulting from herpes zoster (HZ) infection. Based on the duration of symptoms, ZAN is classified into three stages: acute herpetic neuralgia (AHN, less than 1 month), subacute herpetic neuralgia (SHN, 1 to 3 months), and postherpetic neuralgia (PHN, more than 3 months).The global annual incidence of HZ is approximately 3 to 5 per 1,000 individuals, with higher rates observed among individuals aged 50 years and older, and among females. In China, the annual incidence is approximately 4.89 per 1,000 individuals, with a notable increase observed with advancing age.
Pain is the most common clinical symptom of HZ, and its severity correlates with age, immune status, and initial pain intensity. Older adults and immunocompromised patients are more prone to developing PHN . HZ may also lead to complications such as ocular herpes zoster, meningitis, and motor nerve damage, particularly in immunocompromised individuals, where the risk and severity of these complications are significantly elevated . The pathogenesis of PHN remains incompletely understood and may involve inflammatory responses, ion channel alterations, and peripheral/central sensitization . Chronic pain severely impacts patients' quality of life and can lead to psychological issues such as anxiety, depression, and sleep disturbances, imposing substantial burdens on families and society .
ZAN is challenging to treat, with current approaches including pharmacotherapy, nerve blocks, pulsed radiofrequency, and spinal cord stimulation (SCS) . SCS is a minimally invasive neuromodulation technique widely used for chronic pain. It involves implanting electrodes in the epidural space to deliver electrical pulses to the dorsal columns and dorsal horn structures, thereby modulating pain signal transmission. Although the analgesic mechanism of SCS is not fully elucidated, its theoretical basis dates back to the 1965 "gate control theory" proposed by Melzack and Wall. This theory posits that activating large-diameter Aβ afferent fibers inhibits nociceptive signals mediated by small-diameter Aδ and C fibers, reducing spinal sensitization .
Recent studies suggest that SCS also regulates neurotransmitters, suppresses neuroinflammation, and modulates autophagy . At the neurotransmitter level, SCS enhances the release of γ-aminobutyric acid (GABA), reduces glutamate concentrations, amplifies endogenous opioid signaling, and activates the endocannabinoid system, thereby rebalancing dorsal horn activity and inhibiting pain transmission. In neuroinflammatory regulation, SCS elevates anti-inflammatory resolvin D1, reduces pro-inflammatory cytokines (IL-1β, TNF-α), suppresses microglial overactivation, and modulates the p38MAPK pathway, thereby attenuating neuroinflammation and pain hypersensitivity . Additionally, SCS promotes neuronal autophagy, accelerating the clearance of damaged cellular components to restore function and mitigate neural injury, further alleviating pain . These mechanisms collectively support SCS as a multimodal analgesic strategy, driving its clinical adoption.
SCS has shown efficacy in ZAN treatment, particularly for patients refractory to medications or other minimally invasive therapies. However, traditional low-frequency SCS (30-100 Hz), which relies on high-intensity pulses to modulate spinal and ascending pain pathways, often induces paresthesia (e.g., tingling) as a side effect. Clinical limitations include incomplete pain coverage, diminishing efficacy over time, and discomfort in non-target areas, necessitating novel SCS paradigms with improved efficacy and tolerability .
High-frequency spinal cord stimulation (HF-SCS) is an emerging neuromodulation technique that alleviates chronic neuropathic pain without paresthesia and may benefit patients unresponsive to traditional SCS. In China, HF-SCS research remains exploratory, with no clinical studies on ZAN. International studies, though advanced, lack systematic data on ZAN, with heterogeneous parameters (indications, frequency, pulse width, etc.). This study compares short-term 1 kHz HF-SCS with traditional low-frequency SCS in ZAN treatment, evaluating pain relief, psychological status (anxiety/depression), sleep quality, patient experience, and complication rates. The findings aim to establish the safety and efficacy of short-term HF-SCS for ZAN, offering a novel therapeutic option for this challenging condition.
Patients diagnosed with herpes zoster-associated neuralgia undergoing spinal cord electrical stimulation (SCS) surgery.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V
Other: 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
Other: LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V
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
Numerical scale pain score
An NRS score of 0 indicates no pain; scores ≥1 and \<4 indicate mild pain; scores ≥4 and \<6 indicate moderate pain; scores ≥7 indicate severe pain.
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Hamilton Anxiety Rating Scale
A 5-point Likert scale ranging from 0 to 4 is used. A total score ≥29 may indicate severe anxiety; ≥21 indicates definite marked anxiety; ≥14 indicates definite anxiety; a score above 7 may suggest anxiety; a score below 7 indicates no symptoms of anxiety.
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Hamilton Depression Rating Scale
A total HAMD score of less than 7 indicates no depression; a score of 7-17 indicates mild depression; a score of 18-24 indicates moderate depression; and a score above 24 indicates severe depression.
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Pittsburgh sleep quality index
The total PSQI score ranges from 0 to 20, with lower scores indicating better sleep quality. It is used to assess overall sleep quality.
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Started Feb 2024 (actual). Primary completion is estimated for May 2025, 15 months after the start.
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