Zoster; Herpes, Trigeminal Neuralgia (Etiology)NCT06890897
Esketamine Combined Pulsed Radiofrequency for Acute/Subacute Zoster-associated Trigeminal Neuralgia
A study testing Esketamine group and PRF group in people with Zoster; Herpes, Trigeminal Neuralgia (Etiology), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zoster; Herpes, Trigeminal Neuralgia (Etiology)
- 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
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Sep 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
- Age >18 years;
- History of HZ within the last three months;
- Lesions located in the trigeminal nerve or its branches innervated regions；
- Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
- Planned to perform CT-guided PRF treatment of the Gasserian ganglion .
Who cannot join
- Obstructive sleep apnoea syndrome;
- Those who receive other invasive treatments, such as spinal cord stimulation;
- A history of systemic immune diseases, organ transplantation, or cancers;
- A history of severe cardiopulmonary, hepatic or renal dysfunction;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- Comorbid hyperthyroidism or phaeochromocytoma;
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- Recent history of drug abuse;
- Having contraindications to esketamine;
- Communication difficulties.
- Withdrawal criteria
- Lost to follow-up during the study;
- Not perform the planned operation;
- Receiving other treatment regimes during the study period;
- Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study;
- Voluntary withdrawal from the study.
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
Beijing Tiantan Hospital
Beijing, 100050
Fang Luo, M.D, +86 13611326978, 13611326978@163.com
Lu Liu, +86 18618418228, emmaliulu@163.com
About this study
Official title: Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia
To assess the 1-month effects and safety of esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).
Read the detailed description
The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment for refractory patients with ZRTN
- Being tested
- Esketamine group, PRF group
- Keywords
- acute/subacute zoster-associated trigeminal neuralgia, esketamine, pulsed radiofrequency
- Medical subject headings
- Herpes Zoster, Herpes Simplex, Trigeminal Neuralgia
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 treatment
Patients in the esketamine group will receive intravenous infusion of esketamine besides PRF+standardized treatment.The formula will be intravenous infusion of 0.5mg/kg of esketamine diluted in 50 mL normal saline, starting with intravenous injection of 10 mg of esketamine for 1 minute, and maintaining a dose 8 mg/h.The infusion rate will be adjusted the parameter according to the tolerance of the patients
PRF groupDrug
Also called PRF + standardized group
Patients in the control group will receive PRF+standardized treatment
| Study group | Role | What they receive |
|---|---|---|
| Esketamine group | Experimental | Besides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ; Receives: Drug: Esketamine group |
| control group | Active comparator | Patients will only receive PRF plus standardized treatment 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 (5)
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 day, 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 day, 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 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
the type of analgesics and analgesics consumption
Measured: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Safety assessments
intraoperative complications, PRF-related complications, Eskatamine-related complications
Measured: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zoster; Herpes, Trigeminal Neuralgia (Etiology)Studies 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
- 174 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
- Investigators
- Fang Luo, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890897
- Sponsor's protocol ID
- KY-2024-332-02-01
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT06890897
- Acronym / sponsor ID
- KY-2024-332-02-01
- Keywords
- acute/subacute zoster-associated trigeminal neuralgia, esketamine, pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 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 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Mar 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 combined PRF and standardized treatment to relieve pain in patients with acute/subacute zoster-related trigeminal neuralgia(ZRTN).
Detailed description
The investigators aim to investigate whether or not esketamine combined PRF and standardized treatment to relieve pain in patients with acute/subacute ZRTN , and seek a safe, and effective treatment for refractory patients with ZRTN
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 groupBesides PRF plus standardized treatment, patients will also receive intravenous infusion of Esketamine ; |
| control group | Active comparator | Drug: PRF groupPatients will only receive PRF plus standardized treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years;
- History of HZ within the last three months;
- Lesions located in the trigeminal nerve or its branches innervated regions；
- Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy;
- Planned to perform CT-guided PRF treatment of the Gasserian ganglion .
Key exclusion criteria (15 listed)
- Obstructive sleep apnoea syndrome;
- Those who receive other invasive treatments, such as spinal cord stimulation;
- A history of systemic immune diseases, organ transplantation, or cancers;
- A history of severe cardiopulmonary, hepatic or renal dysfunction;
- 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 treatmentPatients in the esketamine group will receive intravenous infusion of esketamine besides PRF+standardized treatment.The formula will be intravenous infusion of 0.5mg/kg of esketamine diluted in 50 mL normal saline, starting with intravenous injection of 10 mg of esketamine for 1 minute, and maintaining a dose 8 mg/h.The infusion rate will be adjusted the parameter according to the tolerance of the patients | Drug | Esketamine group |
| PRF groupAlso: PRF + standardized groupPatients in the control group will receive PRF+standardized treatment | 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
5 secondary outcomes
the 12-item Short-Form Health Survey (SF-12) score
Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Patient Global Impression of Change scale (PGIC)
Time frame: at 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
Time frame: at 1 day, 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
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 27 Apr 2025.
- Individual participant dataSharing planned: No. Not yet
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.
Fang Luo, M.D. principal investigator
Beijing Tiantan Hospital
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 Zoster; Herpes, Trigeminal Neuralgia (Etiology), 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 15 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 27 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, M.D. (+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 27 Apr 2025.