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NCT Number: NCT06914206

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: esketamine+PRF+ standardized drug treatment

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

Other names: PRF+standardized drug treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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).

  4. 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

  5. Analgesics consumption

    Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

    the type of analgesics and analgesics consumption

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing Xiaotangshan Hospital
  • Hengshui People's Hospital
  • The First Hospital of Fangshan District,Beijing

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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