Herpes ZosterNCT06914206
Esketamine Combined With PRF of DRG for Acute/Subacute Zoster-associated Pain
A study testing esketamine group and PRF group in people with Herpes Zoster, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To assess the 1-month effects and safety of esketamine - PRF -standardized drug treatment against PRF -standardized drug treatment acute/subacute zoster-associated pain (ZAP) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- esketamine group and PRF group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Jul 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages more than 18 years;
- Patients with onset of herpes zoster (HZ) rash less than 90 days;
- HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
- Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；
- Planned to perform CT-guided PRF treatment of the dorsal root ganglion(DRG).
Who cannot join
- Obstructive sleep apnoea syndrome;
- Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
- A history of systemic immune diseases, organ transplantation, or cancers;
- A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- Comorbid hyperthyroidism or phaeochromocytoma;
Show all 10Show fewer
- Recent history of drug abuse;
- Having contraindications to esketamine;
- Communication difficulties.
- Women who are preparing for pregnancy, in the pregnancy or lactation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Esketamine Intravenous Infusion Combined With Pulsed Radiofrequency of Dorsal Root Ganglion for Acute and Subacute Herpes Zoster Neuralgia: A Randomized Controlled Trial
To assess the 1-month effects and safety of esketamine - PRF -standardized drug treatment against PRF -standardized drug treatment acute/subacute zoster-associated pain (ZAP) patients.
Read the detailed description
This study aims to determine whether the addition of esketamine to PRF - standardized drug treatment can improve 1 - month pain control and safety profiles in acute/subacute ZAP patients. The findings may help optimize current treatment strategies for refractory ZAP patients.
- Conditions
- Herpes Zoster
- Being tested
- esketamine group, PRF group
- Keywords
- Herpes Zoster Neuralgia, Esketamine
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamine groupDrug
Also called esketamine+PRF+ standardized drug treatment
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
PRF groupDrug
Also called PRF+standardized drug treatment
In the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. The standardized drug treatment will include antiviral therapy, anticonvulsant treatment, three-step analgesic therapy
| Study group | Role | What they receive |
|---|---|---|
| Esketamine group | Experimental | Esketamine+ PRF group Receives: Drug: esketamine group |
| control group | Active comparator | PRF group Receives: Drug: PRF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the NRS score at 1 month after treatment.
The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain
Measured: 1-month period
Secondary outcomes (7)
the NRS score after treatment
Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain.
Measured: at 1 week, 2 weeks, 2 months, 3 months after treatment
the 12-item Short-Form Health Survey (SF-12) score
Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status)
Measured: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).
Measured: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
The Patient Global Impression of Change scale (PGIC)
The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC
Measured: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
the type of analgesics and analgesics consumption
Measured: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Safety assessments
intraoperative complications, PRF-related complications, esketamine-related complications
Measured: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
success rate
The success rate is defined as more than a 50% reduction in NRS-11 score
Measured: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Xiaotangshan Hospital, The First Hospital of Fangshan District,Beijing, Beijing Ditan Hospital, Hengshui People's Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914206
- Sponsor's protocol ID
- KY-2024-332-02-04
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine Intravenous Infusion Combined With Pulsed Radiofrequency of Dorsal Root Ganglion for Acute and Subacute Herpes Zoster Neuralgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06914206
- Acronym / sponsor ID
- KY-2024-332-02-04
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster Neuralgia, Esketamine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Xiaotangshan Hospital, The First Hospital of Fangshan District,Beijing, Beijing Ditan Hospital, Hengshui People's Hospital
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 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.
To assess the 1-month effects and safety of esketamine - PRF -standardized drug treatment against PRF -standardized drug treatment acute/subacute zoster-associated pain (ZAP) patients.
Detailed description
This study aims to determine whether the addition of esketamine to PRF - standardized drug treatment can improve 1 - month pain control and safety profiles in acute/subacute ZAP patients. The findings may help optimize current treatment strategies for refractory ZAP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine group | Experimental | Drug: esketamine groupEsketamine+ PRF group |
| control group | Active comparator | Drug: PRF groupPRF group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages more than 18 years;
- Patients with onset of herpes zoster (HZ) rash less than 90 days;
- HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
- Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；
- Planned to perform CT-guided PRF treatment of the dorsal root ganglion(DRG).
Key exclusion criteria (10 listed)
- Obstructive sleep apnoea syndrome;
- Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
- A history of systemic immune diseases, organ transplantation, or cancers;
- A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
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 |
|---|---|---|
| esketamine groupAlso: esketamine+PRF+ standardized drug treatmentin addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine. | Drug | Esketamine group |
| PRF groupAlso: PRF+standardized drug treatmentIn the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. The standardized drug treatment will include antiviral therapy, anticonvulsant treatment, three-step analgesic therapy | Drug | control group |
Primary outcome
the NRS score at 1 month after treatment.
Time frame: 1-month period
The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain
7 secondary outcomes
the NRS score after treatment
Time frame: at 1 week, 2 weeks, 2 months, 3 months after treatment
the 12-item Short-Form Health Survey (SF-12) score
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
The Patient Global Impression of Change scale (PGIC)
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Safety assessments
Time frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
success rate
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
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 9 Apr 2025.
- Individual participant dataSharing planned: No. not yet decided
Related trials for Herpes Zoster
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
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?
A study testing esketamine group and PRF group in people with Herpes Zoster, run by Beijing Tiantan Hospital 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 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 Fang Luo (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the NRS score at 1 month after treatment. (time frame: 1-month period). 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 9 Apr 2025.