Herpes Zoster PainNCT06942806
The Efficacy of High-frequency Short-time Spinal Cord Stimulation in the Treatment of Herpes Zoster-associated Neuralgia
An observational study of Herpes Zoster Pain, run by Li Zhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Herpes Zoster Pain
- What is being tested?
- HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V and LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with herpes zoster-associated neuralgia undergoing spinal cord electrical stimulation (SCS) surgery.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province
Zunyi, Guizhou, 563000
梨 赵, +8615285410762, 1287802477@qq.com
About this study
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).
Read more
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.
- Conditions
- Herpes Zoster Pain
- Being tested
- 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
- Keywords
- Spinal cord stimulation, Herpes zoster-associated neuralgia, Neuromodulation, High-frequency spinal cord electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 VOther
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 VOther
LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V
| Study group | Role | What they receive |
|---|---|---|
| HF group | HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V Receives: 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 Receives: Other: LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Feb 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Zoster PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Zhao, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942806
- Sponsor's protocol ID
- 20241212
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of High-frequency Short-time Spinal Cord Stimulation in the Treatment of Herpes Zoster-associated Neuralgia
- ClinicalTrials.gov ID
- NCT06942806
- Acronym / sponsor ID
- 20241212
- Conditions
- Herpes Zoster Pain
- Keywords
- Spinal cord stimulation, Herpes zoster-associated neuralgia, Neuromodulation, High-frequency spinal cord electrical stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Li ZhaoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF group | – | Other: HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 VHF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V |
| LF group | – | Other: LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 VLH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with herpes zoster-associated neuralgia undergoing spinal cord electrical stimulation (SCS) surgery.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 VHF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V | Other | HF group |
| LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 VLH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V | Other | LF group |
Primary outcome
Numerical scale pain score
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
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.
3 secondary outcomes
Hamilton Anxiety Rating Scale
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Hamilton Depression Rating Scale
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Pittsburgh sleep quality index
Time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Zoster Pain, run by Li Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 梨 赵 (+8615285410762, 1287802477@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical scale pain score (time frame: Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.