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Sponsor study identifier
observational
74
1 country
1
Study Start
February 1, 2024
Actual (reported)Primary Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2024
Actual (reported)April 16, 2025
Actual (reported)April 24, 2025
Actual (reported)May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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
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
Patients diagnosed with herpes zoster-associated neuralgia undergoing spinal cord electrical stimulation (SCS) surgery.
149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province
Zunyi, Guizhou, 563000, China
First Submitted
April 16, 2025
First Posted
April 24, 2025
Study Start
February 1, 2024
Actual (reported)Primary Completion
May 31, 2025
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 30, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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