Esketamine and pulsed radiofrequency for treating trigeminal neuralgia from shingles
Effect of Intravenous Infusion of Esketamine Combined Pulsed Radiofrequency on Acute/Subacute Zoster-associated Trigeminal Neuralgia
This study is testing whether combining esketamine with pulsed radiofrequency treatment can help people with severe facial pain from shingles feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06890897 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of combining esketamine with pulsed radiofrequency (PRF) treatment for patients suffering from acute or subacute zoster-associated trigeminal neuralgia. Participants will receive standardized treatment alongside these interventions to assess pain relief over a one-month period. The goal is to find a safe and effective option for patients who have not responded to conventional therapies. The study focuses on individuals with significant pain levels and recent herpes zoster infections affecting the trigeminal nerve.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a recent history of herpes zoster and moderate to severe pain despite pharmacotherapy.
Not a fit: Patients with severe comorbid conditions or contraindications to esketamine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief for patients suffering from zoster-related trigeminal neuralgia.
How similar studies have performed: While the combination of esketamine and PRF is a novel approach, similar studies have shown promise in pain management, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years; 2. History of HZ within the last three months; 3. Lesions located in the trigeminal nerve or its branches innervated regions； 4. Numeric Rating Scale (NRS) pain score≥4 (NRS, 0 = no pain, 10= worst possible pain) with pharmacotherapy; 5. Planned to perform CT-guided PRF treatment of the Gasserian ganglion . Exclusion Criteria: 1. Obstructive sleep apnoea syndrome; 2. Those who receive other invasive treatments, such as spinal cord stimulation; 3. A history of systemic immune diseases, organ transplantation, or cancers; 4. A history of severe cardiopulmonary, hepatic or renal dysfunction; 5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium; 6. Comorbid hyperthyroidism or phaeochromocytoma; 7. Recent history of drug abuse; 8. Having contraindications to esketamine; 9. Communication difficulties. Withdrawal criteria 1. Lost to follow-up during the study; 2. Not perform the planned operation; 3. Receiving other treatment regimes during the study period; 4. Not suitable for continuing the study for emerging severe comorbidities or special physiological changes during the study; 5. Voluntary withdrawal from the study.
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Fang Luo, M.D. — Beijing Tiantan Hospital
- Study coordinator: Fang Luo, M.D.
- Email: 13611326978@163.com
- Phone: +86 13611326978
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.