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

April 5, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

Esketamine Intravenous Infusion Combined With Pulsed Radiofrequency of Dorsal Root Ganglion for Acute and Subacute Herpes Zoster Neuralgia: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esketamine group
Esketamine+ PRF group
Drug: esketamine group
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
Other Names:
  • esketamine+PRF+ standardized drug treatment
Active Comparator: control group
PRF group
Drug: PRF group
In the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. The standardized drug treatment will include antiviral therapy, anticonvulsant treatment, three-step analgesic therapy
Other Names:
  • PRF+standardized drug treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 12-item Short-Form Health Survey (SF-12) score
Time Frame: 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)
at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time Frame: 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).
at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
The Patient Global Impression of Change scale (PGIC)
Time Frame: 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
at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
Time Frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the type of analgesics and analgesics consumption
at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
success rate
Time Frame: 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
at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the NRS score after treatment
Time Frame: 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.
at 1 week, 2 weeks, 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
intraoperative complications, PRF-related complications, esketamine-related complications
at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Ditan Hospital
Beijing Xiaotangshan Hospital
Beijing Fangshan District of First Hospital
Halison International Peace Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-332-02-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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