ClinicalTrials.gg
RecruitingNCT06942806Updated Apr 30, 2025

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

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

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
40 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Started
2024
with 8 others
Observational
6 of 51
4 open now
Primary completion
2025-05
later than 2 of 30 live
Registered
32nd of 51
by date

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.

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

Browse Herpes Zoster studies →

Open to participants now

26 of the 51 studies in Herpes Zoster with a site in China are open now. Recruiting first, the newest first:

20 more — sign in →

All 26 open studies →

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 →

Who these studies take

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.

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02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Herpes Zoster Pain

Keywords

  • Spinal cord stimulation
  • Herpes zoster-associated neuralgia
  • Neuromodulation
  • High-frequency spinal cord electrical stimulation
04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with herpes zoster-associated neuralgia undergoing spinal cord electrical stimulation (SCS) surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ≥ 4).

Exclusion criteria

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 ( count \< 80×10⁹/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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (estimated)
Patient registry
No

Groups and cohorts

  • HF group

    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

  • LF group

    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

Interventions

  • OtherHF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V

    HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V

  • OtherLH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V

    LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

07

Study locations

1 of 1 sites recruiting
  • 149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province
    Zunyi, Guizhou 563000, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2024 (actual). Primary completion is estimated for May 2025, 15 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2025
First posted
Apr 24, 2025
StartActual
Feb 1, 2024
Primary completionEst.
May 31, 2025
CompletionEst.
May 31, 2025
Last update
Apr 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06942806
Lead sponsor
Li Zhao
Responsible party
Li Zhao (Attending Physician, Zunyi Medical College) — Sponsor-investigator
First posted
Apr 24, 2025
Start date
Feb 1, 2024
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Apr 30, 2025

Study contacts

梨 赵
Contact
1287802477@qq.com
+8615285410762

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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