耳穴指压治疗化疗引起的神经病变
2026年7月9日 更新者：Jennifer Kawi、The University of Texas Health Science Center, Houston
拟议的随机对照试验将评估耳穴穴位按摩 (APA) 对化疗引起的神经病变 (CIN) 的影响，通过整合自我报告措施、心理物理措施 (QST)、内源性生物标志物（细胞因子）和神经元，严格考虑穴位特异性和安慰剂效应-成像以研究 APA 的功效和潜在机制。
研究人员将使用随机对照试验，三组设计：(1) APA 组，(2) 假 APA 对照，和 (3) 常规护理对照。 用于生态瞬时评估 (EMA) 的智能手机应用程序将用于监测 APA 依从性并捕获瞬时 CIN 严重程度和镇痛剂使用情况。
研究概览
详细说明
化疗引起的神经病 (CIN)——分布在手脚的疼痛、麻木或刺痛——会产生持续的症状，影响癌症幸存者的感觉和平衡。 高达 50% 的癌症幸存者在治疗 6 年后仍然患有 CIN。 美国临床肿瘤学会唯一推荐的药物度洛西汀被发现优于安慰剂，但仅将 CIN 改善了 0.73 分（0-10 级）。 除运动外，尚未确定 CIN 的有效治疗方法，效果大小 <0.508。 阿片类药物可缓解 CIN 疼痛，但由于阿片类药物过度使用，强烈建议不要长期使用。
研究人员建议测试耳穴穴位按摩 (APA)，这是一种从耳针疗法发展而来的创新且可扩展的解决方案。 APA 是一种针对疼痛患者的非侵入性（无针）主动治疗，而针灸是一种侵入性（使用针头）被动治疗（由执业医师实施）。 在 APA 中，熟练的提供者将小种子贴在特定的耳穴上，患者每天按压种子刺激耳穴 3 次，每次 3 分钟，每天总共 9 分钟。 APA 在耳朵刺激后 1-2 分钟内提供疼痛缓解，并在 4 周的 APA 干预后持续缓解疼痛一个月。 APA 在台湾、中国大陆和欧洲很受欢迎。 虽然它在美国的使用很少，但有限数量的临床试验支持 APA 用于疼痛管理。
研究类型
介入性
注册 (实际的)
238
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21205
- Johns Hopkins University
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Texas
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Houston、Texas、美国、77030
- The University of Texas Health Science Center at Houston
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
- 年龄≥18岁的癌症患者
- 已接受以下类别之一的药物治疗：铂类、长春花生物碱、硼替佐米、艾日布林和/或紫杉烷
- 在入组前三个月或更长时间完成化疗
- 由于接受癌症的神经毒性化学疗法而患有 CIN，或者患有化疗后恶化的另一种病因的周围神经病变
- 由于 11 分制的 CIN ≥ 4，前一周四肢出现平均强度的疼痛、麻木或刺痛之一。
排除标准：
- 同时或在过去 30 天内使用研究药物控制疼痛
- 使用植入式给药系统，例如 美敦力 Synchromed®
- 先前的腹腔神经丛阻滞或其他神经松解性疼痛控制治疗
- 化疗前存在的疼痛性感觉异常的其他确定原因（例如，放射或恶性神经丛病、腰椎或颈椎神经根病，）
- 对乳胶过敏（APA 的胶带包括乳胶）。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：耳穴指压 (APA)
APA 部门将每周接受面对面治疗，并使用带有视频的自助式智能手机应用程序，以帮助理解和管理 APA。
APA 部门将接受一次现场种子放置，并为参与者或其护理人员提供将种子放置在耳点上的培训，以及在第一次访问后 1 周召开一次 Zoom 会议，指导参与者和/或护理人员进行种子放置放置。
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亲自放置种子，并为参与者或其护理人员提供将种子放置在耳点上的培训。
种子安置和 APA 辅导的 Zoom 会议将在初始 APA 和种子安置培训之后进行（初始培训可以亲自进行，也可以通过智能手机应用程序视频进行指导）。
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实验性的：虚拟耳穴穴位按压 (vAPA)
VAPA 手臂将根据自助智能手机应用程序中的视频说明放置种子，以自行管理 APA，以了解和管理 APA。
参与者和/或护理人员将遵循有关种子放置的视频说明，并将在基线访问一周后接受一次 APA 辅导的 Zoom 课程。
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种子安置和 APA 辅导的 Zoom 会议将在初始 APA 和种子安置培训之后进行（初始培训可以亲自进行，也可以通过智能手机应用程序视频进行指导）。
根据自助智能手机应用程序中的视频说明放置种子，自行管理 APA，以了解和管理 APA。
参与者和/或护理人员将遵循有关种子放置的视频说明。
其他名称：
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有源比较器：日常护理控制
常规护理部门将继续进行常规护理。
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参与者将继续接受肿瘤科医生的常规护理。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Severity as Assessed by the Brief Pain Inventory
大体时间：Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst pain severity.
The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain
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Baseline, 1 month after baseline
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Numbness as Assessed by the Brief Pain Inventory
大体时间：Baseline, 1 month after Baseline
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Brief Pain Inventory (BPI) assesses worst numbness.
The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.
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Baseline, 1 month after Baseline
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Tingling as Assessed by the Brief Pain Inventory
大体时间：Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst Tingling.
The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.
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Baseline, 1 month after baseline
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Stiffness as Assessed by the Brief Pain Inventory
大体时间：Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst stiffness.
The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.
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Baseline, 1 month after baseline
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Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
大体时间：Baseline, 1 month after baseline
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Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
大体时间：Baseline, 1 month after baseline
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Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale
大体时间：Baseline, 1 month after Baseline
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The BPI-CIN Interference subscale will be used to measure physical function caused by CIN.
The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life.
Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes).
The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference.
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Baseline, 1 month after Baseline
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Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
大体时间：Baseline, 1 month after Baseline
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The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction
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Baseline, 1 month after Baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better physical function.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater fatigue.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater pain interference.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater depression severity.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater anxiety.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater sleep disturbance.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale
大体时间：Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better and higher functioning social participation.
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Baseline, 1 month after baseline
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Upper Limb Function as Assessed by the Quick Dash Index
大体时间：Baseline, 1 month after baseline
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The QuickDASH Index assesses upper limb disability and symptoms.
It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances.
The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability.
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Baseline, 1 month after baseline
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Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory
大体时间：Baseline, 1 month after Baseline
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The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer.
Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine).
The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity.
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Baseline, 1 month after Baseline
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Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)
大体时间：Baseline, 1 month after Baseline
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Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ).
This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain.
Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping.
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Baseline, 1 month after Baseline
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Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score
大体时间：Baseline, 1 month after Baseline
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The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Baseline, 1 month after Baseline
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Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)
大体时间：Baseline, 1 month after Baseline
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Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS).
This instrument identifies the presence of up to 10 common chronic pain conditions.
The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity.
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Baseline, 1 month after Baseline
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Charlson Comorbidity Index
大体时间：Baseline
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The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality.
The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality.
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Baseline
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Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale
大体时间：Baseline, 1 month after baseline
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Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life.
Each item is rated on a 0-10 scale.
The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference.
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Baseline, 1 month after baseline
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Number of Participants Reporting Opioid Use
大体时间：Baseline, Day 28
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Baseline, Day 28
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Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day
大体时间：Baseline, Day 28
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Opioid use will be collected via EMA diary using a questionnaire.
Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid.
Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis.
Baseline was defined as the first day of opioid use recorded in the EMA diary.
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Baseline, Day 28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius
大体时间：Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb
大体时间：Baseline, 1 month after Baseline
|
In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)
大体时间：Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation.
Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
A higher score means greater pain sensitivity and increased temporal summation.
MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
大体时间：Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds.
[ [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
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Baseline, 1 month after Baseline
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Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging
大体时间：Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline
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Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging
大体时间：Baseline, 1 month after Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline, 1 month after Baseline
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The Grooved Pegboard Test-Dominant Hand
大体时间：Baseline, 1 month after baseline
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The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with dominant hand.
Higher times indicate slower performance and reduced dexterity
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Baseline, 1 month after baseline
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The Grooved Pegboard Test-Non Dominant Hand
大体时间：Baseline, 1 month after Baseline
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The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with non-dominant hand.
Higher times indicate slower performance and reduced dexterity
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Baseline, 1 month after Baseline
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Interleukin-1 Alpha Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-1 Beta Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-2 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-4 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-6 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-8 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-10 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p40) (From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p70)-(From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-13 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-17 Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interferon-gamma Level (From Plasma)
大体时间：Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
大体时间：Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
大体时间：1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Transforming Growth Factor-beta Level 1(From Plasma)
大体时间：Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Transforming Growth Factor-beta Level 1 (From Plasma)
大体时间：1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Calcitonin Gene-related Peptide Level(From Plasma)
大体时间：Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Monocyte Chemoattractant Protein-1 Level (From Plasma)
大体时间：Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Eotaxin Level (From Plasma)
大体时间：Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
C-reactive Protein Level (From Plasma)
大体时间：Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nada Lukkahatai, PHD, MSN, RN、Johns Hopkins University
- 首席研究员：Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN、The University of Texas Health Science Center, Houston
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
- Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychol Methods. 2002 Dec;7(4):422-45.
- Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. Springer Science & Business Media; 2009.
- Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
- Vickers AJ, Cronin AM, Maschino AC, Lewith G, Macpherson H, Victor N, Sherman KJ, Witt C, Linde K; Acupuncture Trialists' Collaboration. Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration. Trials. 2010 Sep 28;11:90. doi: 10.1186/1745-6215-11-90.
- Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008.
- Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.
- Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
- Franconi G, Manni L, Schroder S, Marchetti P, Robinson N. A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy. Evid Based Complement Alternat Med. 2013;2013:516916. doi: 10.1155/2013/516916. Epub 2013 Jul 24.
- Flatters SJL, Bennett GJ. Studies of peripheral sensory nerves in paclitaxel-induced painful peripheral neuropathy: evidence for mitochondrial dysfunction. Pain. 2006 Jun;122(3):245-257. doi: 10.1016/j.pain.2006.01.037. Epub 2006 Mar 13.
- Asher GN, Jonas DE, Coeytaux RR, Reilly AC, Loh YL, Motsinger-Reif AA, Winham SJ. Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials. J Altern Complement Med. 2010 Oct;16(10):1097-108. doi: 10.1089/acm.2009.0451.
- Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813.
- Miaskowski C, Mastick J, Paul SM, Abrams G, Cheung S, Sabes JH, Kober KM, Schumacher M, Conley YP, Topp K, Smoot B, Mausisa G, Mazor M, Wallhagen M, Levine JD. Impact of chemotherapy-induced neurotoxicities on adult cancer survivors' symptom burden and quality of life. J Cancer Surviv. 2018 Apr;12(2):234-245. doi: 10.1007/s11764-017-0662-8. Epub 2017 Nov 20.
- Yeh CH, Chiang YC, Hoffman SL, Liang Z, Klem ML, Tam WW, Chien LC, Suen LK. Efficacy of auricular therapy for pain management: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:934670. doi: 10.1155/2014/934670. Epub 2014 Jul 23.
- Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9.
- Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi: 10.1146/annurev.neuro.051508.135531.
- Keller M, Mazuch J, Abraham U, Eom GD, Herzog ED, Volk HD, Kramer A, Maier B. A circadian clock in macrophages controls inflammatory immune responses. Proc Natl Acad Sci U S A. 2009 Dec 15;106(50):21407-12. doi: 10.1073/pnas.0906361106. Epub 2009 Dec 1.
- Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, Ohsumi S, Makino H, Mukai H, Katsumata N, Sunada Y, Watanabe T, Hausheer FH. Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2009 Dec;17(12):1483-91. doi: 10.1007/s00520-009-0613-7. Epub 2009 Mar 28.
- Pike CT, Birnbaum HG, Muehlenbein CE, Pohl GM, Natale RB. Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer. Chemother Res Pract. 2012;2012:913848. doi: 10.1155/2012/913848. Epub 2012 Mar 14.
- Lin WC, Burke L, Schlenk EA, Yeh CH. Use of an Ecological Momentary Assessment Application to Assess the Effects of Auricular Point Acupressure for Chronic Low Back Pain. Comput Inform Nurs. 2019 May;37(5):276-282. doi: 10.1097/CIN.0000000000000478.
- Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
- Shah A, Hoffman EM, Mauermann ML, Loprinzi CL, Windebank AJ, Klein CJ, Staff NP. Incidence and disease burden of chemotherapy-induced peripheral neuropathy in a population-based cohort. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):636-641. doi: 10.1136/jnnp-2017-317215. Epub 2018 Feb 8.
- Park SB. Chemotherapy-induced peripheral neuropathy: highlighting unmet needs. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):558. doi: 10.1136/jnnp-2017-317528. Epub 2018 Feb 20. No abstract available.
- Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, Fung C, Janelsins MC, Asare M, Lin PJ, Reddy PS, Giguere J, Berenberg J, Kesler SR, Mustian KM. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial. Support Care Cancer. 2018 Apr;26(4):1019-1028. doi: 10.1007/s00520-017-4013-0. Epub 2017 Dec 14.
- Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005 Mar 31;352(13):1324-34. doi: 10.1056/NEJMoa042580.
- Gilron I, Tu D, Holden RR, Jackson AC, DuMerton-Shore D. Combination of morphine with nortriptyline for neuropathic pain. Pain. 2015 Aug;156(8):1440-1448. doi: 10.1097/j.pain.0000000000000149.
- Yeh CH, Lukkahatai N, Campbell C, Sair H, Zhang F, Mensah S, Garry C, Zeng J, Chen C, Pinedo M, Khoshnoodi M, Smith TJ, Saligan LN. Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 1 Self-Reported Outcomes. Pain Manag Nurs. 2019 Dec;20(6):614-622. doi: 10.1016/j.pmn.2019.04.005. Epub 2019 May 30.
- Yeh CH, Lin WC, Kwai-Ping Suen L, Park NJ, Wood LJ, van Londen GJ, Howard Bovbjerg D. Auricular Point Acupressure to Manage Aromatase Inhibitor-Induced Arthralgia in Postmenopausal Breast Cancer Survivors: A Pilot Study. Oncol Nurs Forum. 2017 Jul 1;44(4):476-487. doi: 10.1188/17.ONF.476-487.
- Yeh CH, Kwai-Ping Suen L, Chien LC, Margolis L, Liang Z, Glick RM, Morone NE. Day-to-Day Changes of Auricular Point Acupressure to Manage Chronic Low Back Pain: A 29-day Randomized Controlled Study. Pain Med. 2015 Oct;16(10):1857-69. doi: 10.1111/pme.12789. Epub 2015 May 19.
- Yeh CH, Morone NE, Chien LC, Cao Y, Lu H, Shen J, Margolis L, Bhatnagar S, Hoffman S, Liang Z, Glick RM, Suen LK. Auricular point acupressure to manage chronic low back pain in older adults: a randomized controlled pilot study. Evid Based Complement Alternat Med. 2014;2014:375173. doi: 10.1155/2014/375173. Epub 2014 Jul 24.
- Yeh CH, Chien LC, Balaban D, Sponberg R, Primavera J, Morone NE, Glick R, Albers KM, Cohen SM, Ren D, Huang LC, Suen LK. A randomized clinical trial of auricular point acupressure for chronic low back pain: a feasibility study. Evid Based Complement Alternat Med. 2013;2013:196978. doi: 10.1155/2013/196978. Epub 2013 Feb 28.
- Yeh CH, Chien LC, Chiang YC, Huang LC. Auricular point acupressure for chronic low back pain: a feasibility study for 1-week treatment. Evid Based Complement Alternat Med. 2012;2012:383257. doi: 10.1155/2012/383257. Epub 2012 Jul 1.
- Yeh CH, Chien LC, Chiang YC, Ren D, Suen LK. Auricular point acupressure as an adjunct analgesic treatment for cancer patients: a feasibility study. Pain Manag Nurs. 2015 Jun;16(3):285-93. doi: 10.1016/j.pmn.2014.08.005. Epub 2014 Oct 31.
- Yeh CH, Chien LC, Lin WC, Bovbjerg DH, van Londen GJ. Pilot Randomized Controlled Trial of Auricular Point Acupressure to Manage Symptom Clusters of Pain, Fatigue, and Disturbed Sleep in Breast Cancer Patients. Cancer Nurs. 2016 Sep-Oct;39(5):402-10. doi: 10.1097/NCC.0000000000000303.
- Yeh CH, Lukkahatai N, Campbell C, Sair H, Zhang F, Mensah S, Garry C, Zeng J, Chen C, Pinedo M, Khoshnoodi M, Perrin N, Smith TJ, Saligan LN. Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 2 Laboratory-Assessed and Objective Outcomes. Pain Manag Nurs. 2019 Dec;20(6):623-632. doi: 10.1016/j.pmn.2019.04.004. Epub 2019 Jun 14.
- Sisignano M, Baron R, Scholich K, Geisslinger G. Mechanism-based treatment for chemotherapy-induced peripheral neuropathic pain. Nat Rev Neurol. 2014 Dec;10(12):694-707. doi: 10.1038/nrneurol.2014.211. Epub 2014 Nov 4.
- Smith EM, Bridges CM, Kanzawa G, Knoerl R, Kelly JP 4th, Berezovsky A, Woo C. Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update. Curr Pain Headache Rep. 2014 Nov;18(11):459. doi: 10.1007/s11916-014-0459-7.
- Janes K, Esposito E, Doyle T, Cuzzocrea S, Tosh DK, Jacobson KA, Salvemini D. A3 adenosine receptor agonist prevents the development of paclitaxel-induced neuropathic pain by modulating spinal glial-restricted redox-dependent signaling pathways. Pain. 2014 Dec;155(12):2560-2567. doi: 10.1016/j.pain.2014.09.016. Epub 2014 Sep 19.
- Peters CM, Jimenez-Andrade JM, Kuskowski MA, Ghilardi JR, Mantyh PW. An evolving cellular pathology occurs in dorsal root ganglia, peripheral nerve and spinal cord following intravenous administration of paclitaxel in the rat. Brain Res. 2007 Sep 7;1168:46-59. doi: 10.1016/j.brainres.2007.06.066. Epub 2007 Jul 17.
- Ji XT, Qian NS, Zhang T, Li JM, Li XK, Wang P, Zhao DS, Huang G, Zhang L, Fei Z, Jia D, Niu L. Spinal astrocytic activation contributes to mechanical allodynia in a rat chemotherapy-induced neuropathic pain model. PLoS One. 2013 Apr 9;8(4):e60733. doi: 10.1371/journal.pone.0060733. Print 2013.
- Tsavaris N, Kopterides P, Kosmas C, Efthymiou A, Skopelitis H, Dimitrakopoulos A, Pagouni E, Pikazis D, Zis PV, Koufos C. Gabapentin monotherapy for the treatment of chemotherapy-induced neuropathic pain: a pilot study. Pain Med. 2008 Nov;9(8):1209-16. doi: 10.1111/j.1526-4637.2007.00325.x.
- Magnowska M, Izycka N, Kapola-Czyz J, Romala A, Lorek J, Spaczynski M, Nowak-Markwitz E. Effectiveness of gabapentin pharmacotherapy in chemotherapy-induced peripheral neuropathy. Ginekol Pol. 2018;89(4):200-4. doi: 10.5603/GP.a2018.0034.
- Bellingham GA, Peng PW. Duloxetine: a review of its pharmacology and use in chronic pain management. Reg Anesth Pain Med. 2010 May-Jun;35(3):294-303. doi: 10.1097/AAP.0b013e3181df2645.
- Irwin ML, Cartmel B, Gross CP, Ercolano E, Li F, Yao X, Fiellin M, Capozza S, Rothbard M, Zhou Y, Harrigan M, Sanft T, Schmitz K, Neogi T, Hershman D, Ligibel J. Randomized exercise trial of aromatase inhibitor-induced arthralgia in breast cancer survivors. J Clin Oncol. 2015 Apr 1;33(10):1104-11. doi: 10.1200/JCO.2014.57.1547. Epub 2014 Dec 1.
- Lu W, Giobbie-Hurder A, Freedman RA, Shin IH, Lin NU, Partridge AH, Rosenthal DS, Ligibel JA. Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial. Oncologist. 2020 Apr;25(4):310-318. doi: 10.1634/theoncologist.2019-0489. Epub 2019 Oct 14.
- Li K, Giustini D, Seely D. A systematic review of acupuncture for chemotherapy-induced peripheral neuropathy. Curr Oncol. 2019 Apr;26(2):e147-e154. doi: 10.3747/co.26.4261. Epub 2019 Apr 1.
- Smith TJ, Razzak AR, Blackford AL, Ensminger J, Saiki C, Longo-Schoberlein D, Loprinzi CL. A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN). J Palliat Care. 2020 Jan;35(1):53-58. doi: 10.1177/0825859719827589. Epub 2019 Feb 3.
- Pachman DR, Weisbrod BL, Seisler DK, Barton DL, Fee-Schroeder KC, Smith TJ, Lachance DH, Liu H, Shelerud RA, Cheville AL, Loprinzi CL. Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy. Support Care Cancer. 2015 Apr;23(4):943-51. doi: 10.1007/s00520-014-2424-8. Epub 2014 Sep 24.
- Gewandter JS, Chaudari J, Ibegbu C, Kitt R, Serventi J, Burke J, Culakova E, Kolb N, Sluka KA, Tejani MA, Mohile NA. Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study. Support Care Cancer. 2019 May;27(5):1765-1774. doi: 10.1007/s00520-018-4424-6. Epub 2018 Aug 27.
- Galantino ML, Brooks J, Tiger R, Jang S, Wilson K. Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy. Int J Yoga Therap. 2020 Jan 1;30(1):49-61. doi: 10.17761/2020-D-18-00030.
- Kono T, Mamiya N, Chisato N, Ebisawa Y, Yamazaki H, Watari J, Yamamoto Y, Suzuki S, Asama T, Kamiya K. Efficacy of goshajinkigan for peripheral neurotoxicity of oxaliplatin in patients with advanced or recurrent colorectal cancer. Evid Based Complement Alternat Med. 2011;2011:418481. doi: 10.1093/ecam/nep200. Epub 2011 Jan 11.
- Li Y, Cui HJ, Huang JC, Wu XQ. Clinical study of Jiawei Huangqi Guizhi Wuwu Decoction in preventing and treating peripheral neuro-sensory toxicity caused by oxaliplatin. Chin J Integr Med. 2006 Mar;12(1):19-23. doi: 10.1007/BF02857424.
- Liu Y, May BH, Zhang AL, Guo X, Lu C, Xue CC, Zhang H. Integrative Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy and Hand-Foot Syndrome in Colorectal Cancer: A Systematic Review and Meta-Analysis. Integr Cancer Ther. 2019 Jan-Dec;18:1534735418817833. doi: 10.1177/1534735418817833. Epub 2018 Dec 10.
- Tofthagen C, Gonzalez L, Visovsky C, Akers A. Self-management of oxaliplatin-related peripheral neuropathy in colorectal cancer survivors. Chemother Res Pract. 2013;2013:547932. doi: 10.1155/2013/547932. Epub 2013 Aug 25.
- Molsberger AF, Schneider T, Gotthardt H, Drabik A. German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) - a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment. Pain. 2010 Oct;151(1):146-154. doi: 10.1016/j.pain.2010.06.036. Epub 2010 Jul 23.
- Nahin RL, Barnes PM, Stussman BJ. Insurance Coverage for Complementary Health Approaches Among Adult Users: United States, 2002 and 2012. NCHS Data Brief. 2016 Jan;(235):1-8.
- Schapira MM, Mackenzie ER, Lam R, Casarett D, Seluzicki CM, Barg FK, Mao JJ. Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. Support Care Cancer. 2014 May;22(5):1207-15. doi: 10.1007/s00520-013-2073-3. Epub 2013 Dec 21.
- Nogier P. Handbook to auriculotherapy. 1st ed. Moulins-les-Metz: Maisonneuve; 1981.
- Nogier R. How did Paul Nogier establish the map of the ear? Medical Acupuncture. 2014;26(2):76-83.
- Nogier P. Points Reflexes Auricularis. Maisonneuve SA: Moulin Les-Metz, France; 1987.
- Yeh CH, Huang LC. Comprehensive and systematic auricular diagnosis protocol. Medical Acupuncture 2013;25(6):423-436.
- Oleson T. Auriculotherapy Manual: Chinese and Western Systems of Ear Acupuncture. 4th ed. Edinburgh: Churchill Livingstone, Elsevier; 2014.
- Huang LC. Auricular Medicine: A Complete Manual of Auricular Diagnosis and Treatment. 1st ed. Orlando Florida: Auricular International Research & Training; 2005.
- Alimi D, Geissmann A, Gardeur D. Auricular acupuncture stimulation measured on functional magnetic resonance imaging. Medical Acupuncture. 2002;13(2):18-21.
- Romoli M, Allais G, Airola G, Benedetto C, Mana O, Giacobbe M, Pugliese AM, Battistella G, Fornari E. Ear acupuncture and fMRI: a pilot study for assessing the specificity of auricular points. Neurol Sci. 2014 May;35 Suppl 1:189-93. doi: 10.1007/s10072-014-1768-7.
- Fonken LK, Frank MG, Kitt MM, Barrientos RM, Watkins LR, Maier SF. Microglia inflammatory responses are controlled by an intrinsic circadian clock. Brain Behav Immun. 2015 Mar;45:171-9. doi: 10.1016/j.bbi.2014.11.009. Epub 2014 Nov 26.
- Lundeberg T, Lund I. Acupuncture for preconditioning of expectancy and/or Pavlovian extinction. Acupunct Med. 2008 Dec;26(4):234-8. doi: 10.1136/aim.26.4.234.
- Lundeberg T, Lund I, Naslund J. Acupuncture--self-appraisal and the reward system. Acupunct Med. 2007 Sep;25(3):87-99. doi: 10.1136/aim.25.3.87.
- Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, Gagnier J, Ammendolia C, Dryden T, Doucette S, Skidmore B, Daniel R, Ostermann T, Tsouros S. A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain. Evid Based Complement Alternat Med. 2012;2012:953139. doi: 10.1155/2012/953139. Epub 2011 Nov 24.
- Hsu C, Sherman KJ, Eaves ER, Turner JA, Cherkin DC, Cromp D, Schafer L, Ritenbaugh C. New perspectives on patient expectations of treatment outcomes: results from qualitative interviews with patients seeking complementary and alternative medicine treatments for chronic low back pain. BMC Complement Altern Med. 2014 Jul 30;14:276. doi: 10.1186/1472-6882-14-276.
- Schafer LM, Hsu C, Eaves ER, Ritenbaugh C, Turner J, Cherkin DC, Sims C, Sherman KJ. Complementary and alternative medicine (CAM) providers' views of chronic low back pain patients' expectations of CAM therapies: a qualitative study. BMC Complement Altern Med. 2012 Nov 27;12:234. doi: 10.1186/1472-6882-12-234.
- Schnur JB, Hallquist MN, Bovbjerg DH, Silverstein JH, Stojceska A, Montgomery GH. Predictors of expectancies for post-surgical pain and fatigue in breast cancer surgical patients. Pers Individ Dif. 2007;42(3):419-429. doi: 10.1016/j.paid.2006.07.009.
- Lind BK, Lafferty WE, Tyree PT, Sherman KJ, Deyo RA, Cherkin DC. The role of alternative medical providers for the outpatient treatment of insured patients with back pain. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1454-9. doi: 10.1097/01.brs.0000166527.18442.10.
- Shelton RC, Clarke Hillyer G, Hershman DL, Leoce N, Bovbjerg DH, Mandelblatt JS, Kushi LH, Lamerato L, Nathanson SD, Ambrosone CB, Neugut AI. Interpersonal influences and attitudes about adjuvant therapy treatment decisions among non-metastatic breast cancer patients: an examination of differences by age and race/ethnicity in the BQUAL study. Breast Cancer Res Treat. 2013 Feb;137(3):817-28. doi: 10.1007/s10549-012-2370-4. Epub 2012 Dec 22.
- Craig BM, Reeve BB, Brown PM, Cella D, Hays RD, Lipscomb J, Simon Pickard A, Revicki DA. US valuation of health outcomes measured using the PROMIS-29. Value Health. 2014 Dec;17(8):846-53. doi: 10.1016/j.jval.2014.09.005.
- PROMIS-29 Profile v2. http://www.assessmentcenter.net/documents/InstrumentLibrary.pdf. Accessed July 31, 2015.
- (CMS) CfMMS. The 2019 Rate Announcement and Call Letter:and selecting "2019 Announcement.". 2018; https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html Accessed May 24, 2018.
- Campbell CM, Carroll CP, Kiley K, Han D, Haywood C Jr, Lanzkron S, Swedberg L, Edwards RR, Page GG, Haythornthwaite JA. Quantitative sensory testing and pain-evoked cytokine reactivity: comparison of patients with sickle cell disease to healthy matched controls. Pain. 2016 Apr;157(4):949-956. doi: 10.1097/j.pain.0000000000000473.
- Yoo SS, Teh EK, Blinder RA, Jolesz FA. Modulation of cerebellar activities by acupuncture stimulation: evidence from fMRI study. Neuroimage. 2004 Jun;22(2):932-40. doi: 10.1016/j.neuroimage.2004.02.017.
- Yeh CH, Chien LC, Albers KM, et al. Function of auricular point acupressure in inducing changes in inflammatory cytokines during chronic low back pain: A pilot study. Medical Acupuncture. 2014;26(1):31-39.
- Agresti A. Categorical Data Analysis. 2nd ed. New Jersey: John Wiley & Sons Inc.; 2002.
- Xiang L, Tse SK, Lee AH. Influence diagnostics for generalized linear mixed models: applications to clustered data. Computational Statistics & Data Analysis. 2002;40(4):759-774.
- Birhanu T, Molenberghs G, Sotto C, Kenward MG. Doubly robust and multiple-imputation-based generalized estimating equations. J Biopharm Stat. 2011 Mar;21(2):202-25. doi: 10.1080/10543406.2011.550096.
- Zeger SL, Liang KY, Albert PS. Models for longitudinal data: a generalized estimating equation approach. Biometrics. 1988 Dec;44(4):1049-60.
- Lukkahatai N, Nguyen MV, Zhang J, Cho YM, Benjasirisan C, Jia HM, Campbell CM, Kawi J, Wu H, Wang H, Bora R, Thrul J, Johnson CM, Smith TJ. A randomized controlled study of auricular point acupressure to manage chemotherapy-induced neuropathy: Study protocol. PLoS One. 2024 Sep 26;19(9):e0311135. doi: 10.1371/journal.pone.0311135. eCollection 2024.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月8日
初级完成 (实际的)
2025年5月30日
研究完成 (实际的)
2026年3月19日
研究注册日期
首次提交
2021年6月3日
首先提交符合 QC 标准的
2021年6月3日
首次发布 (实际的)
2021年6月9日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.