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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 林啟萬 | zh_TW |
dc.contributor.advisor | Chii-Wann Lin | en |
dc.contributor.author | 陳孟超 | zh_TW |
dc.contributor.author | Meng-Chao Chen | en |
dc.date.accessioned | 2024-01-03T16:14:46Z | - |
dc.date.available | 2024-01-04 | - |
dc.date.copyright | 2024-01-03 | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-12-19 | - |
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dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/91353 | - |
dc.description.abstract | 腕隧道症候群是因正中神經在手腕部位被壓迫所引起的一種常見周圍神經病變。傳統治療方法像是配戴護腕,類固醇注射,用藥,復健或手術,但療效和副作用都有所限制。脈衝射頻刺激已經成為一種嶄新療法,用於治療各種慢性神經病理性疼痛。本論文的目的,是要從動物實驗到人體臨床試驗,開發並評估一種創新經皮脈衝射頻治療裝置,用以治療腕隧道症候群。
在動物實驗部分,首先利用矽膠管壓迫正中神經,建立大白鼠腕隧道症候群模型。治療前後量測其前足的機械性疼痛閾值。接著給予±5伏特、±10伏特與±22.5伏特的經皮脈衝射頻刺激。結果顯示,單次經皮射頻刺激使手術組大白鼠的疼痛耐受度回復到手術前的80%。利用纖維蕊絲刺激測試檢視射頻治療12週後的疼痛反應,高強度射頻刺激相較於低強度,呈現更持久的止痛效果。 基於此研究,及避免太高強度經皮電刺激產生的副作用,我們開發設計出一種低強度、可攜式經皮脈衝射頻治療裝置,將其命名為腕部刺激器 Carpal Stim。它能產生500千赫頻率、25毫秒脈衝寬度、2赫茲脈衝頻率的雙相正弦波。這小型裝置使用CR2430鋰電池供電,並由低功率MSP430微控制器控制。此一嶄新裝置將運用於後續的臨床試驗當中。 第一代腕部刺激器進行了初次人體臨床試驗,共14位腕隧道症候群病患參與。它輸出500千赫頻率、25毫秒脈衝寬度、2赫茲脈衝頻率、10伏特峰值電壓之刺激訊號。治療15分鐘後,病患的疼痛視覺評量表評分從6.7降至3.1。透過重複刺激能維持兩週的止痛效果。整個治療過程安全,無併發症或副作用發生。 最後,進行一項隨機、雙盲、對照組控制的臨床試驗,共58位腕隧道症候群病患參與,比較腕部刺激器與對照組的療效。刺激參數設定為500千赫頻率、25毫秒脈衝寬度、2赫茲脈衝頻率、±6.6伏特峰值電壓。主要療效指標雖無顯著差異,但相較對照組,腕部刺激器在兩週時的疼痛與麻痺感評分有顯著改善及統計上意義。整體而言,此療法安全有效。 綜合以上,本論文從動物實驗到人體臨床試驗,開發並評估了一種經皮脈衝射頻治療裝置,用於腕隧道症候群。腕部刺激器是一種前景看好的非侵入性、非藥物療法,在兩週內可有效紓解病患疼痛。後續研究可持續優化參數,以提升療效。 | zh_TW |
dc.description.abstract | Carpal tunnel syndrome (CTS) is a common peripheral neuropathy caused by compression of the median nerve at the wrist. Conventional treatments include splinting, medication, steroid injection, physical therapy and surgery. These, however, have limitations in terms of efficacy and side effects. Pulsed radiofrequency (PRF) stimulation has emerged as a novel therapy for chronic neuropathic pain conditions. The purpose of this dissertation was to develop and evaluate an innovative transcutaneous PRF device for CTS from preclinical studies to clinical trials.
In the animal studies, a rat model of CTS was established by compressing the median nerve with a silicone tube. Mechanical pain sensitivity of the paw was quantified before and after PRF. Transcutaneous pulsed radiofrequency stimulations at voltage amplitudes of ±5V, ±10V, and ±22.5V were applied. Results showed that single transcutaneous PRF application increased pain tolerance to 80% of baseline compared with sham surgery rats. Pain behaviors were assessed up to 12 weeks after PRF treatment using von Frey filaments. High voltage PRF produced sustained antinociception compared to low voltage PRF. Next, a low voltage and portable transcutaneous PRF device named Carpal Stim was designed and developed. Carpal Stim delivered biphasic sinusoidal waves at 500kHz frequency and 25ms pulse width, along with pulse frequency (2Hz). The small device was powered by a CR2430 lithium coin cell battery and controlled by a low power MSP430 microcontroller. This novel device was used for the following clinical trials. A first-in-human preliminary clinical trial was conducted in 14 CTS patients using first generation Carpal Stim. It generated a 500 kHz signal delivered in 25 ms pulses width at 2 Hz frequency and 10volt amplitude. The mean visual analog scale (VAS) for pain reduced from 6.7 to 3.1 after 15 minutes of PRF treatment in Day 1. Repeated PRF stimulation could maintain pain relief for 2 weeks. No complications or side effects occurred. Finally, a randomized, double-blind, sham-controlled trial was performed in 58 CTS subjects using current Carpal Stim device versus sham device. It generated a 500 kHz signal delivered in 25 ms pulses width at 2 Hz frequency and ± 6.6volt amplitude Although the primary endpoint of responder rate was not significantly different, Carpal Stim resulted in statistically significantly greater pain reduction on the numeric rating scale and GSS numbness score at 2 weeks. Carpal Stim was also safe and well-tolerated. In conclusion, this dissertation presents the development and evaluation of a novel transcutaneous PRF device for CTS from preclinical studies to clinical trials. Carpal Stim is a promising non-invasive, non-pharmacological treatment option that can produce pain relief in CTS patients in 2 weeks. Further studies on parameters and treatment protocol optimization are warranted to improve efficacy. | en |
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dc.description.tableofcontents | 誌謝 i
中文摘要 ii ABSTRACT iv CONTENTS vi LIST OF FIGURES xv LIST OF TABLES xix Chapter 1 Introduction 1 1.1 Background 1 1.2 Declaration of Materials and Methods Presentation 1 1.3 Rationale 2 1.4 Goal and Objectives 2 1.5 Chapter Summary and Overview 3 Chapter 2 Background Literature and Theoretical Basis 5 2.1 Carpal tunnel syndrome (CTS) 5 2.1.1 Introduction 5 2.1.2 Epidemiology and Risk Factors 7 2.1.3 Diagnosis 7 2.1.4 Treatment 8 2.1.5 Conclusions 10 2.2 The Complex Mechanism of Pain Perception: A Review of Physiological Processes and Psychological Influences 11 2.2.1 Introduction 11 2.2.2 Foundational Concepts in Pain Processing 12 2.2.3 Peripheral Mechanisms of Nociception 14 2.2.4 Ascending Pain Pathway Transmission 14 2.2.5 Central Pain Processing Mechanisms 15 2.2.6 Theoretical Frameworks of Pain 16 2.2.7 Modulatory Processes and Influences 17 2.2.8 Pathological Pain States 18 2.2.9 Translational Impacts on Clinical Practice 19 2.2.10 Future Directions and Conclusion 20 2.3 Transcutaneous Electrical Nerve Stimulation (TENS) 21 2.3.1 Mechanisms of Action 21 2.3.2 Clinical Applications 22 2.3.3 Efficacy of TENS Across Acute and Chronic Pain Conditions 23 2.3.4 Specific TENS Parameters Target Different Neural Mechanisms 25 2.3.5 TENS Electrode Placement and Clinical Applications 26 2.3.6 Electrical Stimulation Waveforms 27 2.3.7 Treatment Procedures 30 2.3.8 Recent Research and Advances 31 2.3.9 Technical Treatment Parameters and Dosing Considerations 32 2.4 Pulsed Radiofrequency (PRF) 33 2.4.1 Pulsed Radiofrequency (PRF) in The Clinical Setting 33 2.4.2 Introduction 34 2.4.3 Basic Theory of Pulsed Radiofrequency Actions 35 2.4.4 Molecular Mechanisms 36 2.4.5 Modulation of Neural Signaling 37 2.4.6 Structural Alterations 37 2.4.7 Conclusions 38 2.5 Pulsed Radiofrequency (PRF) for Carpal Tunnel Syndrome 38 2.6 Transcutaneous Pulsed Radiofrequency (TPRF) 42 2.6.1 Review of Comparative Clinical Trials 43 2.6.2 Mechanistic Insights 44 2.6.3 Clinical Implications and Limitations 45 2.6.4 The potentials of TPRF 46 2.6.5 Conclusion 47 Chapter 3 Preclinical Studies on a Rat Model of CTS 48 3.1 Introduction 49 3.1.1 Types and Differences of Pain 49 3.1.2 Carpal Tunnel Syndrome 49 3.1.3 Clinical Applications of Transcutaneous Electrical Stimulation 51 3.1.4 Gate Control Theory of Analgesia by Electrical Stimulation 51 3.1.5 Transcutaneous Electrical Stimulation 52 3.1.6 Clinical Use of Radiofrequency Stimulation 53 3.1.7 Analgesic Effect of Spinal Nerve Ligation Model after Pulsed Radiofrequency 54 3.1.8 Effect of Pulsed Radiofrequency on Dorsal Root Ganglion 54 3.1.9 Effect of Pulsed Radiofrequency on Neurotransmitters 55 3.1.10 Mechanism of Pulsed Radiofrequency Analgesia 55 3.1.11 Parameter Selection of Pulsed Radiofrequency 56 3.2 Animal Models of Peripheral Neuropathic Pain 56 3.2.1 Chronic Constriction Injury Model 56 3.2.2 Partial Sciatic Nerve Ligation Model 57 3.2.3 Spinal Nerve Ligation Model 57 3.2.4 Assessment of Pain Behaviors in Animals 57 3.3 Prior Studies on Low-Voltage Pulsed RF Stimulation in Animal Neuropathic Pain Models 58 3.3.1 Validation of Low Voltage Pulsed Radiofrequency Stimulation in a Model of Pathologic Neuropathic Pain 58 3.3.2 Behavioral Assessment of Pathological Neuropathic Pain Induced by Spinal Nerve Ligation Models 59 3.3.3 Spinal Dorsal Horn Nociceptive Mediators 60 3.3.4 Neurotransmitter Validation of Peripheral Neuropathic Pain 64 3.3.5 Behavioral Assessment of Low Voltage Pulsed Radiofrequency Stimulation for Chronic Pain 67 3.3.6 Observation of Pulse Waveform Differences in Behavioral Assessment 68 3.3.7 Animal Models of Carpal Tunnel Syndrome 70 3.4 Finite Element Analysis (FEA) and Electric Field 70 3.5 Clinical Evaluation and Goal of Applying Transcutaneous Pulsed Radiofrequency for Neuropathic Pain 74 3.6 Objectives and Motivation 75 3.7 Methods and Materials 76 3.7.1 Carpal Tunnel Syndrome Model and Surgery 76 3.7.2 Paw Withdrawal Test for Assessing Mechanical Sensitivity 76 3.7.3 PRF Stimulation Parameters and Device Design 77 3.7.4 Animal Studies 78 3.8 Results 81 3.8.1 Behavioral Assessment of Neuropathic Pain in The Rat Forepaw Model 81 3.8.2 Comparison of Transcutaneous PRF Voltages on Analgesic Effects 81 3.8.3 Long-Term Effects of High Voltage Transcutaneous PRF 82 3.8.4 Results Summary 83 3.9 Discussion 84 3.9.1 Efficacy of TPRF in a rat model of CTS 84 3.9.2 Optimal Stimulation Parameters 85 3.9.3 Median Nerve Size 86 3.9.4 Different Electric Field Distribution with Transcutaneous and DRG PRF Stimulations. 87 3.9.5 Potential Mechanisms of TPRF Neuromodulation 88 3.9.6 Limitations and Future Research 91 3.10 Conclusion 92 Chapter 4 Design and Development of the Carpal Stim Device 93 4.1 Introduction 93 4.2 Design Concept and Background 95 4.3 Design of A Portable Low-Voltage Pulsed Radiofrequency Stimulator 96 4.4 Prototype Device Design Requirements 99 4.5 Results 100 4.5.1 Proposed Device Concept 103 4.5.2 Miniaturized Design 103 4.5.3 Manufacturing and Assembly of The Carpal Stim Device 106 4.6 Discussion 112 4.6.1 Importance of Frequency and Pulse Width Control 112 4.6.2 Miniaturization and Portability 112 4.6.3 Potential Clinical Impact 113 4.6.4 Future Directions 113 4.7 Conclusion 114 Chapter 5 A First-in-Human Pilot Feasibility Study 115 5.1 Introduction 115 5.1.1 Background on carpal tunnel syndrome 115 5.1.2 Pathophysiology of CTS 116 5.1.3 Introduction to pulsed radiofrequency (PRF) 116 5.1.4 Rationale for investigating transcutaneous PRF for CTS 116 5.1.5 Limitations of Current Treatments 116 5.1.6 Experimental studies on PRF for neuropathic pain 117 5.1.7 Clinical applications of PRF for chronic pain 117 5.1.8 Potential advantages of transcutaneous approach 117 5.2 Methods 118 5.2.1 Background on Participant Information and Consent 118 5.2.2 Study design 119 5.2.3 Description of intervention 120 5.2.4 Repeat stimulation 121 5.2.5 Finite Element Analysis Model and Device Design 121 5.2.6 Administration of TPRF Treatment 123 5.2.7 Follow-Up Process 124 5.3 Results 125 5.4 Discussion 127 5.4.1 Implications and Future Directions of This Study 127 5.4.2 Study Design Considerations 128 5.4.3 The Value of This Initial Pilot Study 130 5.5 Conclusion 131 Chapter 6 A Multi-Center Double-Blind Randomized Controlled Trial 133 6.1 Introduction 134 6.1.1 Management of Carpal Tunnel Syndrome 134 6.1.2 Electrical Nerve Stimulation for Pain Control 136 6.1.3 Pulsed Radiofrequency Stimulation 137 6.1.4 Non- Portable TENS-PRF 138 6.1.5 Gimer Portable TENS-PRF (Carpal Stim) 139 6.1.6 Rationale for Study 140 6.2 Methods 142 6.2.1 Study Design 142 6.2.2 Study Device 143 6.2.3 Study Subjects 146 6.2.4 Study Procedures 147 6.2.5 Study Assessments 149 6.2.6 Statistical Analysis 150 6.3 Results 151 6.3.1 Subject Disposition and Baseline Characteristics 151 6.3.2 Medical History 153 6.3.3 Protocol Deviations 154 6.3.4 Treatment Compliance and Blinding 155 6.3.5 Efficacy Outcomes 155 6.3.6 Secondary Outcome Analysis 157 6.3.7 Safety Outcomes 162 6.4 Discussion 164 6.4.1 General Discussions 164 6.4.2 Efficacy 171 6.4.3 Safety 173 6.4.4 Subject Follow-up and Adherence 174 6.4.5 Qualitative Feedback 175 6.4.6 Subgroup Analysis 176 6.4.7 Individual Subject Outcomes 176 6.4.8 Interpretation of Outcomes 177 6.4.9 Limitations 178 6.5 Conclusions 182 Chapter 7 Discussion 184 7.1 Preclinical Animal Models of Carpal Tunnel Syndrome 184 7.2 Computational Modeling of The Electric Fields 186 7.3 Miniaturized and Portable Design of Carpal Stim 188 7.4 Pilot Feasibility Study 190 7.5 Multicenter Randomized Controlled Trial 192 7.6 Clinical Research Organizations Play a Significant Role 194 7.7 Regulatory Process for The Carpal Stim Device 196 7.8 The Impedance of The Skin-Electrode Interface 197 7.9 Bipolar Pulsed Radiofrequency 199 7.10 Optimal PRF Parameters 199 7.11 Why Median Nerve Was Selected as The Target For TPRF? 202 7.12 Potential Applications of Targeted Transcutaneous Pulsed Radiofrequency Stimulation for Peripheral Neuropathic Pain Syndromes 203 Chapter 8 Conclusions and Prospects 205 Reference 207 | - |
dc.language.iso | en | - |
dc.title | 新型經皮脈衝射頻電刺激器於腕隧道症候群之應用:從實驗室到臨床 | zh_TW |
dc.title | A Novel Transcutaneous Pulsed Radiofrequency Stimulation Device for Carpal Tunnel Syndrome: From Bench to Bedside | en |
dc.type | Thesis | - |
dc.date.schoolyear | 112-1 | - |
dc.description.degree | 博士 | - |
dc.contributor.oralexamcommittee | 溫永銳;彭志維;許昇峰;方文良 | zh_TW |
dc.contributor.oralexamcommittee | Yeong-Ray Wen;Chih-Wei Peng;Sheng-Feng Hsu ;Wen-Liang Fang | en |
dc.subject.keyword | 腕隧道症候群,經皮脈衝射頻電刺激,病理性神經疼痛,人體試驗,新型經皮神經電刺激裝置,腕部刺激器, | zh_TW |
dc.subject.keyword | Carpal tunnel syndrome,transcutaneous pulsed radiofrequency stimulation,neuropathic pain,clinical trial,novel transcutaneous electrical nerve stimulator,Carpal Stim, | en |
dc.relation.page | 235 | - |
dc.identifier.doi | 10.6342/NTU202304527 | - |
dc.rights.note | 同意授權(限校園內公開) | - |
dc.date.accepted | 2023-12-19 | - |
dc.contributor.author-college | 工學院 | - |
dc.contributor.author-dept | 醫學工程學系 | - |
顯示於系所單位: | 醫學工程學研究所 |
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