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
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.
- 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