{"title":"千赫兹频率交流电无创电极治疗脊髓损伤后神经性疼痛的有效性和安全性：一项随机、单盲、假对照研究。","authors":"Niannian Shuai, Yuyao Zhu, Yao Xiao, Bin Yu","doi":"10.2147/JPR.S528057","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the effectiveness and safety of noninvasive kilohertz frequency alternating current (KHFAC) therapy for neuropathic pain in patients following spinal cord injury.</p><p><strong>Methods: </strong>In this randomized, single-blind, sham-controlled trial conducted from June 1, 2023, to January 31, 2024, 50 patients suffering from neuropathic pain post-spinal cord injury were assigned to receive either KHFAC or sham stimulation for 7 days, complemented by twice-daily oral administration of 75 mg pregabalin. Outcomes were assessed using the Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), and Brief Pain Inventory (BPI) at baseline, at the end of treatment, and 30 days post-treatment. The primary outcome was the effective rate at the end of treatment, defined as a decrease in VAS score of 30% or more.</p><p><strong>Results: </strong>At the end of the 7-day treatment period, the experimental group demonstrated a significantly higher response rate, with 60% of participants achieving a 30% or greater reduction in VAS scores compared to 28% in the control group (X²=5.195, P<0.05). During this initial period, KHFAC effectively decreased pain intensity, reduced the frequency of paroxysmal pain, and lessened the need for additional analgesics. It also improved sleep quality and overall quality of life relative to sham stimulation. However, at the 30-day follow-up, no statistically significant differences were observed between the groups.</p><p><strong>Conclusion: </strong>KHFAC is effective and safe for short-term neuropathic pain relief and quality of life enhancement in spinal cord injury patients, without an increase in adverse events versus sham stimulation. However, while reductions in analgesic use suggest potential lasting benefits, the long-term effectiveness remains uncertain. Further studies are required to assess the persistence of these effects.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry, ChiCTR2300068114.</p>","PeriodicalId":16661,"journal":{"name":"Journal of Pain Research","volume":"18 ","pages":"3321-3330"},"PeriodicalIF":2.5000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12228514/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Kilohertz Frequency Alternating Current with Non-Invasive Electrodes for Treatment of Neuropathic Pain After Spinal Cord Injury: A Randomized, Single-Blind, Sham-Controlled Study.\",\"authors\":\"Niannian Shuai, Yuyao Zhu, Yao Xiao, Bin Yu\",\"doi\":\"10.2147/JPR.S528057\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the effectiveness and safety of noninvasive kilohertz frequency alternating current (KHFAC) therapy for neuropathic pain in patients following spinal cord injury.</p><p><strong>Methods: </strong>In this randomized, single-blind, sham-controlled trial conducted from June 1, 2023, to January 31, 2024, 50 patients suffering from neuropathic pain post-spinal cord injury were assigned to receive either KHFAC or sham stimulation for 7 days, complemented by twice-daily oral administration of 75 mg pregabalin. Outcomes were assessed using the Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), and Brief Pain Inventory (BPI) at baseline, at the end of treatment, and 30 days post-treatment. The primary outcome was the effective rate at the end of treatment, defined as a decrease in VAS score of 30% or more.</p><p><strong>Results: </strong>At the end of the 7-day treatment period, the experimental group demonstrated a significantly higher response rate, with 60% of participants achieving a 30% or greater reduction in VAS scores compared to 28% in the control group (X²=5.195, P<0.05). During this initial period, KHFAC effectively decreased pain intensity, reduced the frequency of paroxysmal pain, and lessened the need for additional analgesics. It also improved sleep quality and overall quality of life relative to sham stimulation. However, at the 30-day follow-up, no statistically significant differences were observed between the groups.</p><p><strong>Conclusion: </strong>KHFAC is effective and safe for short-term neuropathic pain relief and quality of life enhancement in spinal cord injury patients, without an increase in adverse events versus sham stimulation. However, while reductions in analgesic use suggest potential lasting benefits, the long-term effectiveness remains uncertain. Further studies are required to assess the persistence of these effects.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry, ChiCTR2300068114.</p>\",\"PeriodicalId\":16661,\"journal\":{\"name\":\"Journal of Pain Research\",\"volume\":\"18 \",\"pages\":\"3321-3330\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12228514/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pain Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/JPR.S528057\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pain Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/JPR.S528057","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Efficacy and Safety of Kilohertz Frequency Alternating Current with Non-Invasive Electrodes for Treatment of Neuropathic Pain After Spinal Cord Injury: A Randomized, Single-Blind, Sham-Controlled Study.
Objective: To evaluate the effectiveness and safety of noninvasive kilohertz frequency alternating current (KHFAC) therapy for neuropathic pain in patients following spinal cord injury.
Methods: In this randomized, single-blind, sham-controlled trial conducted from June 1, 2023, to January 31, 2024, 50 patients suffering from neuropathic pain post-spinal cord injury were assigned to receive either KHFAC or sham stimulation for 7 days, complemented by twice-daily oral administration of 75 mg pregabalin. Outcomes were assessed using the Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), and Brief Pain Inventory (BPI) at baseline, at the end of treatment, and 30 days post-treatment. The primary outcome was the effective rate at the end of treatment, defined as a decrease in VAS score of 30% or more.
Results: At the end of the 7-day treatment period, the experimental group demonstrated a significantly higher response rate, with 60% of participants achieving a 30% or greater reduction in VAS scores compared to 28% in the control group (X²=5.195, P<0.05). During this initial period, KHFAC effectively decreased pain intensity, reduced the frequency of paroxysmal pain, and lessened the need for additional analgesics. It also improved sleep quality and overall quality of life relative to sham stimulation. However, at the 30-day follow-up, no statistically significant differences were observed between the groups.
Conclusion: KHFAC is effective and safe for short-term neuropathic pain relief and quality of life enhancement in spinal cord injury patients, without an increase in adverse events versus sham stimulation. However, while reductions in analgesic use suggest potential lasting benefits, the long-term effectiveness remains uncertain. Further studies are required to assess the persistence of these effects.
Trial registration: Chinese Clinical Trial Registry, ChiCTR2300068114.
期刊介绍：
Journal of Pain Research is an international, peer-reviewed, open access journal that welcomes laboratory and clinical findings in the fields of pain research and the prevention and management of pain. Original research, reviews, symposium reports, hypothesis formation and commentaries are all considered for publication. Additionally, the journal now welcomes the submission of pain-policy-related editorials and commentaries, particularly in regard to ethical, regulatory, forensic, and other legal issues in pain medicine, and to the education of pain practitioners and researchers.
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