Herpes Zoster PainPhase 4NCT06959147
High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia
A Phase 4 study testing High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group and High-Voltage Long-Duration Pulsed Radiofrequency in people with Herpes Zoster Pain and Neuralgia, Postherpetic, run by Shirong Tan at 1 site in China.
Trial summary
Research Objectives Background and Significance: Zoster-associated neuralgia (ZAN) refers to neuropathic pain experienced by herpes zoster (HZ) patients before, during, and after rash resolution, characterized by paroxysmal, lightning-like, or knife-like sensations. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Herpes Zoster Pain, Neuralgia, Postherpetic
- What is being tested?
- High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group and High-Voltage Long-Duration Pulsed Radiofrequency
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to 31 May 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:
- Voluntarily provided written informed consent.
- Inadequate response to pharmacological or other non-surgical therapies OR intolerable drug-related adverse effects.
- Herpes zoster (HZ) lesions involving cranial/cervicocephalic, cervical, thoracic, or lumbar dermatomes.
- Moderate-to-severe pain intensity, defined as a Numerical Rating Scale (NRS) score ≥4 at baseline.
- Aged between 40 and 85 years.
- Body weight: Male ≥50 kg; female ≥45 kg.
Who cannot join
- Severe cardiovascular diseases or life-threatening arrhythmias (e.g., heart failure, third-degree atrioventricular block without pacemaker implantation).
- Contraindications to minimally invasive interventions (e.g., coagulation disorders, active infections).
- Allergy to local anesthetics or lipid emulsions; Severe dysfunction of vital organs (cardiac, pulmonary, hepatic, or renal) rendering the patient unfit for the procedure.
- Severe endocrine disorders or long-term use of corticosteroids/immunosuppressive agents.
- Cognitive impairment or inability to cooperate with treatment protocols.
- Prior history of neuromodulation therapies (e.g., spinal cord stimulation or pulsed radiofrequency (PRF) treatment).
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
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Shirong Tan, +8615085046515, 15085046515@163.com
About this study
Research Objectives Background and Significance: Zoster-associated neuralgia (ZAN) refers to neuropathic pain experienced by herpes zoster (HZ) patients before, during, and after rash resolution, characterized by paroxysmal, lightning-like, or knife-like sensations. Postherpetic neuralgia (PHN), a common type of chronic pain, is often accompanied by physical-psychological impairments, social dysfunction, and anxiety-depression. While high-voltage long-term pulsed radiofrequency (HL-PRF) has become a conventional treatment for ZAN, it is limited by residual postoperative localized pain and suboptimal efficacy for refractory cases. Liposomal bupivacaine (LB), a sustained-release analgesic providing up to 72 hours of pain relief, offers potential for combined subcutaneous injection to enhance symptomatic control.
Study Process:
Read more
This clinical study focuses on evaluating the efficacy of HL-PRF combined with LB subcutaneous injection in treating ZAN. The trial will be conducted from December 16, 2024, to December 14, 2026, with an anticipated enrollment of 92 participants. Patients will be randomized into two groups:
HL-PRF group: Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG).
HL-PRF+LB group: HL-PRF treatment followed by LB subcutaneous injection at the painful lesion site 2 hours post-procedure.
Clinical data will be collected preoperatively, and inflammatory factors will be assessed on the first postoperative day. Follow-up evaluations via telephone will occur at 1 week, 1 month, 3 months, and 6 months postoperatively. By analyzing changes in observed indicators before and after treatment, this study aims to determine the clinical efficacy of combining HL-PRF with LB subcutaneous injection for ZAN.
- Conditions
- Herpes Zoster Pain, Neuralgia, Postherpetic
- Being tested
- High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group, High-Voltage Long-Duration Pulsed Radiofrequency
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine groupDrug
High-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block
High-Voltage Long-Duration Pulsed RadiofrequencyOther
High-Voltage Long-Duration Pulsed Radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| HL-PRF+LB group | Experimental | After high-voltage pulsed radiofrequency (HL-PRF) treatment targeting the dorsal root ganglion (DRG), a local anesthetic (Liposomal bupivacaine) was administered via subcutaneous injection at the painful lesion site 2 hours post-procedure. Receives: Drug: High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group |
| HL-PRF group | Other | Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG). Receives: Other: High-Voltage Long-Duration Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
0 indicates no pain,1-3 indicate mild pain,4-6 indicate moderate pain, 7-10indicate severe pain.
Measured: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions
Secondary outcomes (5)
The Zoster Brief Pain Inventory
The instrument comprises two validated domains: pain intensity quantification and pain-related functional interference assessment. With higher composite scores (range: 0-20) indicating greater multidimensional health impairment.
Measured: Baseline and on days 7, 30, 90 ,180 post-interventions
Pittsburgh Sleep Quality Index Scale
Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 20, with lower scores indicating better sleep quality, thereby assessing overall sleep status.
Measured: Baseline and on days 7, 30, 90 ,180 post-interventions
Use of analgesics (tramadol, gabapentin, or pregabalin)
Analgesic consumption metrics, including frequency of use and morphine equivalent daily dose (MEDD), were recorded to evaluate longitudinal changes in pain intensity."
Measured: Baseline and on days 7, 30, 90,180 post-interventions
Adverse event rate
Adverse events include:
Surgery-related complications (e.g., pneumothorax, hematoma, wound infection); Complications associated with bupivacaine liposome subcutaneous block, such as: Cardiac adverse events (e.g., arrhythmias, hypotension); Local tissue toxicity (e.g., myonecrosis, neuropathy).
Measured: Day 1 post-interventions
Expression levels of interleukin-6 (IL-6)
Interleukin-6 (IL-6) levels are positively correlated with the severity of postherpetic neuralgia (PHN) pain.
Measured: Baseline and day 1 post-interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start17 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirong Tan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shirong Tan, Zunyi Medical College
- Investigators
- Jie Yuan, Principal investigator, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959147
- Sponsor's protocol ID
- KLLY-2024-236
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via email (15085046515@163.com)
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia
- ClinicalTrials.gov ID
- NCT06959147
- Acronym / sponsor ID
- KLLY-2024-236
- Conditions
- Herpes Zoster Pain, Neuralgia, Postherpetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Shirong TanUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 6 May 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.
Research Objectives Background and Significance: Zoster-associated neuralgia (ZAN) refers to neuropathic pain experienced by herpes zoster (HZ) patients before, during, and after rash resolution, characterized by paroxysmal, lightning-like, or knife-like sensations. Postherpetic neuralgia (PHN), a common type of chronic pain, is often accompanied by physical-psychological impairments, social dysfunction, and anxiety-depression. While high-voltage long-term pulsed radiofrequency (HL-PRF) has become a conventional treatment for ZAN, it is limited by residual postoperative localized pain and suboptimal efficacy for refractory cases. Liposomal bupivacaine (LB), a sustained-release analgesic providing up to 72 hours of pain relief, offers potential for combined subcutaneous injection to enhance symptomatic control.
Study Process:
This clinical study focuses on evaluating the efficacy of HL-PRF combined with LB subcutaneous injection in treating ZAN. The trial will be conducted from December 16, 2024, to December 14, 2026, with an anticipated enrollment of 92 participants. Patients will be randomized into two groups:
HL-PRF group: Under CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG).
HL-PRF+LB group: HL-PRF treatment followed by LB subcutaneous injection at the painful lesion site 2 hours post-procedure.
Clinical data will be collected preoperatively, and inflammatory factors will be assessed on the first postoperative day. Follow-up evaluations via telephone will occur at 1 week, 1 month, 3 months, and 6 months postoperatively. By analyzing changes in observed indicators before and after treatment, this study aims to determine the clinical efficacy of combining HL-PRF with LB subcutaneous injection for ZAN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL-PRF+LB group | Experimental | Drug: High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine groupAfter high-voltage pulsed radiofrequency (HL-PRF) treatment targeting the dorsal root ganglion (DRG), a local anesthetic (Liposomal bupivacaine) was administered via subcutaneous injection at the painful lesion site 2 hours post-procedure. |
| HL-PRF group | Other | Other: High-Voltage Long-Duration Pulsed RadiofrequencyUnder CT-guided localization, high-voltage pulsed radiofrequency (HL-PRF) therapy was precisely delivered to the pathologically compromised dorsal root ganglion (DRG). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:
- Voluntarily provided written informed consent.
- Inadequate response to pharmacological or other non-surgical therapies OR intolerable drug-related adverse effects.
- Herpes zoster (HZ) lesions involving cranial/cervicocephalic, cervical, thoracic, or lumbar dermatomes.
- Moderate-to-severe pain intensity, defined as a Numerical Rating Scale (NRS) score ≥4 at baseline.
Key exclusion criteria (6 listed)
- Severe cardiovascular diseases or life-threatening arrhythmias (e.g., heart failure, third-degree atrioventricular block without pacemaker implantation).
- Contraindications to minimally invasive interventions (e.g., coagulation disorders, active infections).
- Allergy to local anesthetics or lipid emulsions; Severe dysfunction of vital organs (cardiac, pulmonary, hepatic, or renal) rendering the patient unfit for the procedure.
- Severe endocrine disorders or long-term use of corticosteroids/immunosuppressive agents.
- Cognitive impairment or inability to cooperate with treatment protocols.
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 |
|---|---|---|
| High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine groupHigh-Voltage Long-Duration Pulsed Radiofrequency Combined with Liposomal Bupivacaine Subcutaneous Block | Drug | HL-PRF+LB group |
| High-Voltage Long-Duration Pulsed RadiofrequencyHigh-Voltage Long-Duration Pulsed Radiofrequency | Other | HL-PRF group |
Primary outcome
NRS
Time frame: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions
0 indicates no pain,1-3 indicate mild pain,4-6 indicate moderate pain, 7-10indicate severe pain.
5 secondary outcomes
The Zoster Brief Pain Inventory
Time frame: Baseline and on days 7, 30, 90 ,180 post-interventions
Pittsburgh Sleep Quality Index Scale
Time frame: Baseline and on days 7, 30, 90 ,180 post-interventions
Use of analgesics (tramadol, gabapentin, or pregabalin)
Time frame: Baseline and on days 7, 30, 90,180 post-interventions
Adverse event rate
Time frame: Day 1 post-interventions
Expression levels of interleukin-6 (IL-6)
Time frame: Baseline and day 1 post-interventions
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 6 May 2025.
- Individual participant dataSharing planned: Yes. Via email (15085046515@163.com)
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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.
Jie Yuan principal investigator
Zunyi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-Voltage Long-Duration Pulsed Radiofrequency plus Liposomal Bupivacaine group and High-Voltage Long-Duration Pulsed Radiofrequency in people with Herpes Zoster Pain and Neuralgia, Postherpetic, run by Shirong Tan 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 7 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 6 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shirong Tan (+8615085046515, 15085046515@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Baseline and on days 1, 3, 7, 30, 90 ,180 post-interventions). 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 6 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.