Actively Recruiting

Age: 40Years - 85Years
All Genders
NCT06942806

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

Led by Li Zhao · Updated on 2025-04-30

74

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Patients with inadequate response to non-surgical treatments such as pharmacotherapy;
  2. Patients with major organ dysfunction intolerant to drug therapy;
  3. Patients with systemic comorbidities (e.g., hypertension, diabetes mellitus);
  4. Patients with moderate to severe pain intensity (Numerical Rating Scale [NRS] score ≥ 4).
Not Eligible

You will not qualify if you...

  1. Patients with severe psychiatric disorders;
  2. Patients with severe local or systemic infections at the puncture site;
  3. Patients with severe coagulopathies (platelet count < 80×10⁹/L during puncture) or those requiring uninterrupted anticoagulation therapy without bridging protocol;
  4. Patients with end-stage organ failure who cannot maintain prone positioning or tolerate the procedure;
  5. Patients with severe spinal stenosis, vertebral ankylosis, or scoliosis;
  6. Patients with language barrier or impaired communication abilities.ion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

Zunyi, Guizhou, China, 563000

Actively Recruiting

Loading map...

Research Team

梨 赵

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here