Postherpetic; Neuralgia, Trigeminal (Etiology)NCT06914180
Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia
A study testing esketamine group in people with Postherpetic; Neuralgia, Trigeminal (Etiology), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic; Neuralgia, Trigeminal (Etiology)
- What is being tested?
- esketamine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 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;
- Pain persisting for over three months following the onset of the herpes zoster skin rash;
- Lesions located in the trigeminal nerve or its branches innervated regions；
- 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 gasserian ganglion(GG).
Who cannot join
- Obstructive sleep apnoea syndrome;
- Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of GG.
- 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;
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- 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: Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency for Trigeminal Postherpetic Neuralgia
This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN).
Read the detailed description
This study aims to determine whether the addition of esketamine to the PRF regimen can relieve pain in TPHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory TPHN patients
- Being tested
- esketamine group, control group
- Keywords
- trigeminal postherpetic neuralgia, esketamine
- Medical subject headings
- 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
In the esketamine group, in addition to receiving PRF treatment+pregabalin for rescue analgesia, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.
control groupDrug
Also called PRF
In the control group, patients will receive PRF+pregabaline treatment. Pulsed radiofrequency (PRF) will be performed on GG by a designated physician in each participating center. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to GG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes.
| Study group | Role | What they receive |
|---|---|---|
| esketamine group | Experimental | In addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine Receives: Drug: esketamine group |
| control group | Placebo comparator | patients will receive PRF treatment+pregabalin Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point Numeric Rating Scale（NRS）
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: 7-day period
Secondary outcomes (7)
average weekly NRS score
average weekly NRS score of each participants for rescue analgesia.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: up to 12 weeks
averaged weekly analgesic consumption
averaged weekly consumption per analgesic of each participant
Measured: up to 12 weeks
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 the end of weeks 1, 2, 4, 8, and 12 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 the end of weeks 1, 2, 4, 8, and 12 after treatment
the Patient Global Impression of Change scale (PGIC)
The Patient Global Impression of Change (PGIC) is usually a 7 - point scale. The scale title is "Patient Global Impression of Change". The minimum value is 1 and the maximum value is 7.In summary, for the PGIC scale, lower scores (from 1 to 3) mean a better outcome, indicating improvement in the patient's condition, while higher scores (from 5 to 7) mean a worse outcome, suggesting a deterioration of the condition. Score 4 represents a neutral state of no change.
Measured: At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Hospital Anxiety and Depression Scale (HADS)
It 6.consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.
Measured: At the end of weeks 1, 2, 4, 8, and 12 after treatment
Safety assessments
intraoperative complications, PRF-related complications, Eskatamine-related complications, Pregabaline-related complications
Measured: Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 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 Postherpetic; Neuralgia, Trigeminal (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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914180
- Sponsor's protocol ID
- KY-2024-332-02-03
- Status last verified
- Apr 2025
- First submitted
- 25 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
- Intravenous Infusion of Esketamine in Combination With Pulsed Radiofrequency for Trigeminal Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT06914180
- Acronym / sponsor ID
- KY-2024-332-02-03
- Keywords
- trigeminal postherpetic neuralgia, esketamine
- Study type
- Interventional
- Recruitment status
- Not yet 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 (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.
This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN).
Detailed description
This study aims to determine whether the addition of esketamine to the PRF regimen can relieve pain in TPHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory TPHN 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 groupIn addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine |
| control group | Placebo comparator | Drug: control grouppatients will receive PRF treatment+pregabalin |
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;
- Pain persisting for over three months following the onset of the herpes zoster skin rash;
- Lesions located in the trigeminal nerve or its branches innervated regions；
- 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 gasserian ganglion(GG).
Key exclusion criteria (10 listed)
- Obstructive sleep apnoea syndrome;
- Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of GG.
- 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+PRFIn the esketamine group, in addition to receiving PRF treatment+pregabalin for rescue analgesia, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels. | Drug | esketamine group |
| control groupAlso: PRFIn the control group, patients will receive PRF+pregabaline treatment. Pulsed radiofrequency (PRF) will be performed on GG by a designated physician in each participating center. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to GG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes. | Drug | control group |
Primary outcome
1.the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point Numeric Rating Scale（NRS）
Time frame: 7-day period
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
average weekly NRS score
Time frame: up to 12 weeks
averaged weekly analgesic consumption
Time frame: up to 12 weeks
the 12-item Short-Form Health Survey (SF-12) score
Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Patient Global Impression of Change scale (PGIC)
Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
the Hospital Anxiety and Depression Scale (HADS)
Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
Safety assessments
Time frame: Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 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
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 in people with Postherpetic; Neuralgia, Trigeminal (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 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. Some participants in this study may receive a placebo. 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?
1.the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point Numeric Rating Scale（NRS） (time frame: 7-day 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.