10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial
BackgroundDiabetic peripheral neuropathic pain (DPNP), affecting ~50% of diabetes patients, imposes major burdens on quality of life and healthcare systems, while current therapies including pharmacotherapy and conventional spinal cord stimulation remain limited by insufficient efficacy and adverse...
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Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2025.1611970/full |
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| author | Chen Li Chen Li Chun-Hua Liu Chun-Hua Liu Yi-Fan Li Hui-Min Hu Hui-Min Hu Qing Shi Qing Shi An-Xiang Liu An-Xiang Liu Wen-Hui Liu Wen-Hui Liu Yi Zhang Peng Mao Bi-Fa Fan |
| author_facet | Chen Li Chen Li Chun-Hua Liu Chun-Hua Liu Yi-Fan Li Hui-Min Hu Hui-Min Hu Qing Shi Qing Shi An-Xiang Liu An-Xiang Liu Wen-Hui Liu Wen-Hui Liu Yi Zhang Peng Mao Bi-Fa Fan |
| author_sort | Chen Li |
| collection | DOAJ |
| description | BackgroundDiabetic peripheral neuropathic pain (DPNP), affecting ~50% of diabetes patients, imposes major burdens on quality of life and healthcare systems, while current therapies including pharmacotherapy and conventional spinal cord stimulation remain limited by insufficient efficacy and adverse effects. Our study aims to evaluate the clinical efficacy and safety of 10 kHz high-frequency spinal cord stimulation (HF-SCS) compared to traditional low-frequency SCS (T-SCS) in alleviating DPNP.MethodsThis prospective, randomized, controlled, multicenter trial will enroll 100 participants with DPNP. Patients aged 18–80 with chronic (≥6-month) lower limb pain will be randomly assigned to HF-SCS (10 kHz) vs. T-SCS (40–60 Hz). The primary outcome is the treatment efficacy rate, defined as ≥50% reduction in numeric rating scale (NRS) scores at 3 months post-intervention. Secondary outcomes include improvements in quality of life (Short Form 12), sleep quality (Athens Insomnia Scale), psychological status (Beck Depression Inventory), neuropathy severity (Michigan Neuropathy Screening Instrument), and microcirculatory parameters assessed via infrared thermography. Safety evaluations encompass adverse events, laboratory tests, and imaging findings.DiscussionThis study seeks to provide robust evidence on the superiority of HF-SCS in pain relief, functional improvement, and microcirculatory benefits, potentially establishing it as a preferred neuromodulation strategy for DPNP. Findings may advance clinical practice by addressing unmet needs in chronic pain management through targeted, mechanism-driven interventions.Clinical trial registrationhttps://www.chictr.org.cn/indexEN.html, identifier: ChiCTR2300078291. |
| format | Article |
| id | doaj-art-ccd728cc79164b568ba351ccbb8dba06 |
| institution | DOAJ |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj-art-ccd728cc79164b568ba351ccbb8dba062025-08-20T03:19:17ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-06-011610.3389/fneur.2025.1611970161197010 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trialChen Li0Chen Li1Chun-Hua Liu2Chun-Hua Liu3Yi-Fan Li4Hui-Min Hu5Hui-Min Hu6Qing Shi7Qing Shi8An-Xiang Liu9An-Xiang Liu10Wen-Hui Liu11Wen-Hui Liu12Yi Zhang13Peng Mao14Bi-Fa Fan15Graduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaGraduate School, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaDepartment of Pain Medicine, China-Japan Friendship Hospital, Beijing, ChinaBackgroundDiabetic peripheral neuropathic pain (DPNP), affecting ~50% of diabetes patients, imposes major burdens on quality of life and healthcare systems, while current therapies including pharmacotherapy and conventional spinal cord stimulation remain limited by insufficient efficacy and adverse effects. Our study aims to evaluate the clinical efficacy and safety of 10 kHz high-frequency spinal cord stimulation (HF-SCS) compared to traditional low-frequency SCS (T-SCS) in alleviating DPNP.MethodsThis prospective, randomized, controlled, multicenter trial will enroll 100 participants with DPNP. Patients aged 18–80 with chronic (≥6-month) lower limb pain will be randomly assigned to HF-SCS (10 kHz) vs. T-SCS (40–60 Hz). The primary outcome is the treatment efficacy rate, defined as ≥50% reduction in numeric rating scale (NRS) scores at 3 months post-intervention. Secondary outcomes include improvements in quality of life (Short Form 12), sleep quality (Athens Insomnia Scale), psychological status (Beck Depression Inventory), neuropathy severity (Michigan Neuropathy Screening Instrument), and microcirculatory parameters assessed via infrared thermography. Safety evaluations encompass adverse events, laboratory tests, and imaging findings.DiscussionThis study seeks to provide robust evidence on the superiority of HF-SCS in pain relief, functional improvement, and microcirculatory benefits, potentially establishing it as a preferred neuromodulation strategy for DPNP. Findings may advance clinical practice by addressing unmet needs in chronic pain management through targeted, mechanism-driven interventions.Clinical trial registrationhttps://www.chictr.org.cn/indexEN.html, identifier: ChiCTR2300078291.https://www.frontiersin.org/articles/10.3389/fneur.2025.1611970/fulldiabetic peripheral neuropathic painhigh-frequency spinal cord stimulationrandomized controlled trialneuromodulationprotocol |
| spellingShingle | Chen Li Chen Li Chun-Hua Liu Chun-Hua Liu Yi-Fan Li Hui-Min Hu Hui-Min Hu Qing Shi Qing Shi An-Xiang Liu An-Xiang Liu Wen-Hui Liu Wen-Hui Liu Yi Zhang Peng Mao Bi-Fa Fan 10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial Frontiers in Neurology diabetic peripheral neuropathic pain high-frequency spinal cord stimulation randomized controlled trial neuromodulation protocol |
| title | 10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial |
| title_full | 10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial |
| title_fullStr | 10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial |
| title_full_unstemmed | 10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial |
| title_short | 10 kHz spinal cord stimulation vs. traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial |
| title_sort | 10 khz spinal cord stimulation vs traditional low frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain study protocol for a multi center randomized controlled clinical trial |
| topic | diabetic peripheral neuropathic pain high-frequency spinal cord stimulation randomized controlled trial neuromodulation protocol |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2025.1611970/full |
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