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Not yet recruiting NCT06914206

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

No phase Interventional Herpes Zoster

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: esketamine group, PRF group.
Who it may be relevant to
Registry conditions: Herpes Zoster. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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

Primary outcome measures

  • the NRS score at 1 month after treatment. [Time frame: 1-month period]
Secondary outcome measures (7)
  • the NRS score after treatment [Time frame: at 1 week, 2 weeks, 2 months, 3 months after treatment]
  • 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]
  • the Pittsburgh Sleep Quality Index (PSQI) score [Time frame: 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]
  • Analgesics consumption [Time frame: at 1 week, 2 weeks, 1 month, 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]
  • success rate [Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment]

Eligibility criteria

Inclusion criteria

  • Ages more than 18 years;
  • Patients with onset of herpes zoster (HZ) rash less than 90 days;
  • HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
  • 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 dorsal root ganglion(DRG).

Exclusion criteria

  • Obstructive sleep apnoea syndrome;
  • Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
  • 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;
  • Recent history of drug abuse;
  • Having contraindications to esketamine;
  • Communication difficulties.
  • Women who are preparing for pregnancy, in the pregnancy or lactation period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06914206 · KY-2024-332-02-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗