Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain
Effect on Symptomatic Release and Sleep Quality of Remote Fu's Subcutaneous Needling on Patients With Chronic Neck Pain
研究概览
详细说明
Neck pain combining limited range of motion is very common. Lasting for only a few days, it will taper off without any treatment. If the neck pain symptoms persist for more than two months without any improvement, it will be categorized as chronic neck pain causing not only pain but also functional impact, even in daily life, working, and sleep quality.
Fu's subcutaneous needling is utilized in treating disease related with myofascial trigger point, including soft tissue pain, joint pain, even some internal problems. Indeed it reduce pain immediately with no obvious side effects. There were some clinical articles of subjective symptoms description published lacking scientific accessment of efficacy.
Research team leading by Professor Chang-Zern Hong has already prove that excitability can be reduced by distal acupuncture. Needling TE5 and LI11 can reduce pain intensity and average amplitude of MTrPs end plate in upper trapezium m., and increase pain pressure threshold.
Comparing to traditional acupuncture, whether safer and pain-less Fu's subcutaneous needle also has the distal treatment effect or not still needs more scientific experiment to prove. This is a randomized controlled trial to compare the efficacy of Transcutaneous electrical nerve stimulation and Fu's subcutaneous needle on chronic neck pain by using more objective assessment tools such as Neck Disability Index, Visual Analog Scales, Pressure Pain Threshold and Myotone of MTrPs of Upper Trapezius Muscles, Range of Motion of Stretch of Upper Trapezius Muscle, and Pittsburgh sleep quality index.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Taichung、台湾、999079
- 招聘中
- China Medical University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Having chronic neck pain for more than 2 months and subjective subjective pain intensity (VAS) greater than 5 points.
- Patients with myofascial pain diagnosed with unilateral upper trapezius muscle.
- This pain is not effective for previous medication or physical therapy.
Exclusion Criteria:
- Contraindications for general treatment, such as serious medical problems, recent trauma, or pregnancy.
- There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- Have received neck, upper back, or upper and lower limb surgery.
- People with central or peripheral nerve disease.
- Cognitive dysfunction cannot be matched with the experimenter.
- People with cardiac pacemakers, epilepsy, etc. cannot place electrode patches on the skin.
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Fu's subcutaneous needling
In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
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Fu's 皮下针 (FSN) 是治疗肌筋膜疼痛和触发点的一项创新。 该针为非注射针，两根针都是操纵作用于软结缔组织。 FSN 不包括肌肉和深筋膜层，仅局限于胶原纤维最丰富的皮下层。 由于皮下层的神经支配较差，因此疼痛比其他针刺疗法要少。 FSN 目前也被成功用于治疗非肌肉骨骼疾病。 |
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有源比较器：Transcutaneous electrical nerve stimulation
In this arm, the subjects will receive the intervention of TENS on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
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经皮神经电刺激（TENS 或 TNS）是使用设备产生的电流来刺激神经以达到治疗目的。 根据定义，TENS 涵盖了用于神经兴奋的经皮应用电流的完整范围，尽管该术语通常用于更严格的意图，即描述用于治疗疼痛的便携式刺激器产生的脉冲类型。 该装置通常使用两个或多个电极连接到皮肤。 典型的电池供电 TENS 单元能够调制脉冲宽度、频率和强度。 通常 TENS 以高频（> 50 Hz）应用，强度低于运动收缩（感觉强度）或低频（ |
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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视觉模拟量表
大体时间：1天
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视觉模拟量表或视觉模拟量表 (VAS) 是一种心理测量反应量表，可用于问卷调查。
它是对无法直接测量的主观特征或态度的测量工具。
在响应 VAS 项目时，受访者通过指示沿两个端点之间的连续线的位置来指定他们对声明的同意程度。
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1天
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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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Neck Disability Index
大体时间：1 week
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The NDI is a modification of the Oswestry Low Back Pain Disability Index .
It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
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1 week
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Pressure Pain Threshold
大体时间：1day
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Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
This measure has proven to be commonly useful in evaluating tenderness symptom.
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1day
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Myotone of MTrPs
大体时间：1day
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Muscle tone is the muscle's resistance to passive stretch during resting state.
Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.
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1day
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Pittsburgh sleep quality index
大体时间：1 week
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The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations.
The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders.
Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures
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1 week
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合作者和调查者
调查人员
- 首席研究员：Li-Wei Chou, PhD、China Medical University Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
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