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

NCT06942806 | Recruiting

• 1 other identifier: 20241212
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Herpes Zoster Pain

Keywords

Spinal cord stimulation; Herpes zoster-associated neuralgia; Neuromodulation; High-frequency spinal cord electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Numerical scale pain score

  An NRS score of 0 indicates no pain; scores ≥1 and \<4 indicate mild pain; scores ≥4 and \<6 indicate moderate pain; scores ≥7 indicate severe pain.

  Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.

Secondary Outcomes (3)

• Hamilton Anxiety Rating Scale

  Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.

• Hamilton Depression Rating Scale

  Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.

• Pittsburgh sleep quality index

  Preoperative, postoperative day 7, postoperative day 30, postoperative day 90, postoperative day 180.

Study Arms (2)

HF group

HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V

Other: HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V

LF group

LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V

Other: LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V

Interventions

HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V OTHER

HF-SCS parameter settings: Frequency 1000 Hz, pulse width 60-180 μs, amplitude 0.5-3.0 V

HF group

LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V OTHER

LH-SCS parameter settings: Frequency 30-100 Hz, pulse width 100-300 μs, amplitude 0.5-5.0 V

LF group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with herpes zoster-associated neuralgia undergoing spinal cord electrical stimulation (SCS) surgery.

You may qualify if:

• Patients with inadequate response to non-surgical treatments such as pharmacotherapy;
• Patients with major organ dysfunction intolerant to drug therapy;
• Patients with systemic comorbidities (e.g., hypertension, diabetes mellitus);
• Patients with moderate to severe pain intensity (Numerical Rating Scale \[NRS\] score ≥ 4).

You may not qualify if:

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

Sponsors & Collaborators

• Li Zhao: lead

Study Sites (1)

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

Zunyi, Guizhou, 563000, China

RECRUITING

Central Study Contacts

梨 赵

CONTACT

+8615285410762; 1287802477@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: February 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)