Combining high-voltage pulsed radiofrequency with liposomal bupivacaine for treating herpes zoster pain

High-Voltage Long-Duration Pulsed Radiofrequency Combined With Liposomal Bupivacaine Subcutaneous Block for Herpes Zoster-Associated Neuralgia

This study is testing if a combination of a special type of radiofrequency treatment and a pain relief injection can help people aged 40 to 85 who have severe pain from shingles feel better when other treatments haven't worked.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Zunyi Medical College (other)
• Locations: 1 site (Zunyi, Guizhou)
• Trial ID: NCT06959147 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of high-voltage long-duration pulsed radiofrequency (HL-PRF) combined with liposomal bupivacaine (LB) for patients suffering from zoster-associated neuralgia (ZAN). The study aims to improve pain management in individuals who have not responded adequately to other treatments or have experienced intolerable side effects. Participants will receive HL-PRF and LB subcutaneous injections to assess their pain relief over time. The trial is designed for patients aged 40 to 85 with moderate to severe pain levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 85 with moderate to severe zoster-associated neuralgia who have not found relief from other treatments.

Not a fit: Patients with severe cardiovascular diseases, contraindications to minimally invasive procedures, or allergies to local anesthetics may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance pain relief for patients suffering from herpes zoster-associated neuralgia.

How similar studies have performed: While HL-PRF has been used in similar contexts, the combination with liposomal bupivacaine is a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Patients diagnosed with zoster-associated neuralgia (ZAN) who meet ALL of the following conditions:

* Voluntarily provided written informed consent.
* Inadequate response to pharmacological or other non-surgical therapies OR intolerable drug-related adverse effects.
* Herpes zoster (HZ) lesions involving cranial/cervicocephalic, cervical, thoracic, or lumbar dermatomes.
* Moderate-to-severe pain intensity, defined as a Numerical Rating Scale (NRS) score ≥4 at baseline.
* Aged between 40 and 85 years.
* Body weight: Male ≥50 kg; female ≥45 kg.

Exclusion Criteria:

* Severe cardiovascular diseases or life-threatening arrhythmias (e.g., heart failure, third-degree atrioventricular block without pacemaker implantation).
* Contraindications to minimally invasive interventions (e.g., coagulation disorders, active infections).
* Allergy to local anesthetics or lipid emulsions; Severe dysfunction of vital organs (cardiac, pulmonary, hepatic, or renal) rendering the patient unfit for the procedure.
* Severe endocrine disorders or long-term use of corticosteroids/immunosuppressive agents.
* Cognitive impairment or inability to cooperate with treatment protocols.
* Prior history of neuromodulation therapies (e.g., spinal cord stimulation or pulsed radiofrequency (PRF) treatment).

Where this trial is running

Zunyi, Guizhou

• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (RECRUITING)

Study contacts

• Principal investigator: Jie Yuan — Zunyi Medical College
• Study coordinator: Shirong Tan

Conditions: Herpes Zoster Pain, Neuralgia, Postherpetic