Actively Recruiting

Phase 2
Age: 40Years - 85Years
All Genders
ID06978192

Clinical Efficacy of Long-Duration High-Voltage Pulsed Radiofrequency Combined with Dexmedetomidine Nasal Spray for Herpes Zoster Pain

Led by Fenghui Deng · Updated on 2025-05-18

92

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial focuses on adults aged 40 to 85 years suffering from herpes zoster-associated neuropathic pain that has not responded well to conventional drug treatment. The study aims to evaluate the effects of combining dexmedetomidine nasal spray with long-duration high-voltage pulsed radiofrequency therapy compared to pulsed radiofrequency therapy alone. It is a randomized, controlled, phase 2 study designed to explore new treatment methods that may help reduce pain and improve patients' quality of life. Participants will be randomly assigned to one of two groups. The experimental group will receive dexmedetomidine nasal spray before the pulsed radiofrequency treatment, specifically before bedtime on the day of the procedure and for three nights afterward, in addition to standard drug treatment. The control group will receive only the long-duration high-voltage pulsed radiofrequency therapy along with conventional drug treatment. Heart rate, blood pressure, and blood oxygen levels will be closely monitored before, during, and after the procedure. During the study, participants will be evaluated using the Numerical Pain Rating Scale and the Hamilton Anxiety Scale at several time points: before treatment, and then 7, 30, 90, and 180 days afterward. Additional assessments include sleep quality, inflammation markers, and blood pressure measurements. Follow-up contacts will be conducted by phone at 1 week, 1 month, 3 months, and 6 months after treatment. Participants will provide medical history details and report any discomfort or issues during the study. Privacy and confidentiality of participant information will be maintained throughout the trial.

CONDITIONS

Brief Title

Clinical Study on the Treatment of Herpes Zoster Pain With Dexmedetomidine Combined With Long-term High Voltage

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 40 to 85 years with herpes zoster-related pain
  • Pain not effectively controlled by conventional drug treatments
  • Pain located in the corresponding nerve area
  • Pain affects daily life or work
  • Diagnostic nerve block provides effective pain relief
  • Patients with recurrent herpes zoster pain
Not Eligible

You will not qualify if you...

  • Infection at the puncture site or systemic infection that may spread
  • Malignant tumors near the puncture area
  • Contraindications to minimally invasive interventional therapy such as coagulation or platelet disorders
  • Allergies to local anesthetics or inhalants
  • Heart, lung, liver, kidney, or other major organ failure preventing surgery
  • Severe endocrine diseases or long-term hormone or immunosuppressive therapy
  • Presence of cardiac pacemakers
  • Pregnant or breastfeeding women
  • Cognitive dysfunction or poor coordination
  • Previous treatment with electrical stimulation or pulsed radiofrequency therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 days

Participants receive long-duration high-voltage pulsed radiofrequency therapy. Those in the dexmedetomidine nasal spray group also use the nasal spray before the treatment and on the three subsequent nights.

1 treatment day and 3 days of nasal spray administration (in-person and at home)

Follow-up

Duration - 6 months

Participants are evaluated for pain, anxiety, and sleep quality at multiple time points after treatment to monitor outcomes and recovery.

Visits on Day 7, Day 30, Day 90, and Day 180 after treatment (in-person)

Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China, 563000

Actively Recruiting

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Research Team

F

Fenghui Deng

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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