NCT06942806

The Efficacy of High-frequency Short-time Spinal Cord Stimulation in the Treatment of Herpes Zoster-associated Neuralgia

Recruiting now Last updated 30 April 2025

What this trial tests

trial testing HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V in Herpes Zoster Pain in 74 participants. Currently enrolling.

Timeline

1 February 2024

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	Li Zhao
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	74
Start date	1 February 2024
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	1 location across China

Drugs / interventions tested

• HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V
• LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V

Conditions studied

• Herpes Zoster Pain — all drugs for Herpes Zoster Pain →

Sponsor

Li Zhao — full company profile →

Who can join

Adults 40 to 85, any sex, with Herpes Zoster Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Zoster-associated neuralgia (ZAN) is a type of neuropathic pain caused by the reactivation of the varicella-zoster virus (VZV). The global annual incidence is approximately 3-5 per 1,000 individuals, and in China, the incidence is around 4.89 per 1,000 individuals, increasing with age. The underlying mechanisms of ZAN involve neuroinflammation, peripheral and central sensitization, and other factors, ultimately leading to anxiety, depression, and significant reductions in quality of life. Treating ZAN remains challenging.

Spinal cord stimulation (SCS) alleviates pain via multiple mechanisms, including the gate control theory, modulation of neurotransmitters (e.g., gamma-aminobutyric acid), suppression of neuroinflammation (e.g., reduced levels of IL-1β and TNF-α), and promotion of autophagy. However, traditional low-frequency SCS (30-100 Hz) is limited by incomplete pain coverage, reduced long-term efficacy, and side effects such as paresthesia (e.g., tingling sensations).

High-frequency SCS (HF-SCS, 1,000 Hz) offers pain relief without inducing paresthesia. Studies have suggested that it may be superior to traditional SCS. However, clinical data on the use of HF-SCS in ZAN are limited, and no such studies have been conducted in China.

This study aims to compare the efficacy of short-term high-frequency (1 kHz) SCS with traditional low-frequency SCS in the treatment of ZAN. By evaluating outcomes such as pain relief (NRS scores), improvements in anxiety and depression (HADS), sleep quality (PSQI), patient-reported experience, and complication rates, this research seeks to assess the safety and efficacy of short-term HF-SCS, thereby potentially providing a novel therapeutic strategy for patients with ZAN.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.