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

NCT06914206 | Not Yet Recruiting DMC

• 1 other identifier: KY-2024-332-02-04
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

Herpes Zoster Neuralgia; Esketamine

Outcome Measures

Primary Outcomes (1)

• 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

  1-month period

Secondary Outcomes (7)

• the NRS score after treatment

  at 1 week, 2 weeks, 2 months, 3 months after treatment

• the 12-item Short-Form Health Survey (SF-12) score

  at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

• the Pittsburgh Sleep Quality Index (PSQI) score

  at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

• The Patient Global Impression of Change scale (PGIC)

  at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

• Analgesics consumption

  at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

Study Arms (2)

Esketamine group

EXPERIMENTAL

Esketamine+ PRF group

Drug: esketamine group

control group

ACTIVE COMPARATOR

PRF group

Drug: PRF group

Interventions

esketamine group DRUG

in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.

Also known as: esketamine+PRF+ standardized drug treatment

Esketamine group

PRF group DRUG

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

Also known as: PRF+standardized drug treatment

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Xiaotangshan Hospital: collaborator
• The First Hospital of Fangshan District,Beijing: collaborator
• Beijing Ditan Hospital: collaborator
• Hengshui People's Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day surgery and Pain Management

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)