Effect on Symptomatic Release and Sleep Quality of Remote Fu's Subcutaneous Needling on Patients With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Visual Analog Scales
研究概览
简要总结
This is a randomized controlled trial to compare the efficacy of Fu's subcutaneous needle (FSN) and Transcutaneous electrical nerve stimulation (TENS) 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fu's subcutaneous needling (Procedure)
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.
干预措施: Transcutaneous electrical nerve stimulation (Procedure)
结局指标
主要结局
Visual Analog Scales
时间窗: 1 day
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
次要结局
- Pressure Pain Threshold(1day)
- Neck Disability Index(1 week)
- Pittsburgh sleep quality index(1 week)
- Myotone of MTrPs(1day)
研究者
Li-Wei Chou
Minister of Rehabilitation
China Medical University Hospital