Esketamine Combined With PRF of DRG for Acute/Subacute Zoster-associated Pain

Not Applicable

Not yet recruiting

• Conditions: Herpes Zoster
• Interventions: Drug: esketamine group; Drug: PRF group

• Registration Number: NCT06914206
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-04-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Ages more than 18 years;
2. Patients with onset of herpes zoster (HZ) rash less than 90 days;
3. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
4. Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；
5. Planned to perform CT-guided PRF treatment of the dorsal root ganglion(DRG).

Exclusion Criteria

1. Obstructive sleep apnoea syndrome;
2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
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.
10. Women who are preparing for pregnancy, in the pregnancy or lactation period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine group	esketamine group	Esketamine+ PRF group
control group	PRF group	PRF group

Primary Outcome Measures

Name	Time	Method
the NRS score at 1 month after treatment.	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

Secondary Outcome Measures

Name	Time	Method
the NRS score after treatment	at 1 week, 2 weeks, 2 months, 3 months after treatment	Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain.
the 12-item Short-Form Health Survey (SF-12) score	at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment	Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status)
the Pittsburgh Sleep Quality Index (PSQI) score	at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment	Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).
The Patient Global Impression of Change scale (PGIC)	at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment	The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC
Analgesics consumption	at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment	the type of analgesics and analgesics consumption
Safety assessments	at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months	intraoperative complications, PRF-related complications, esketamine-related complications
success rate	at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment	The success rate is defined as more than a 50% reduction in NRS-11 score

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China