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临床试验/NCT03605563
NCT03605563Unknown不适用

Changes in the Muscle Tone of Affected Muscle After Fu's Subcutaneous Needling on the Myofascial Trigger Points - a Sample of Lateral Epicondylitis

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

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

Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The symptoms can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.

This is a randomized study, the investigators will evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling on the patients suffering with lateral epicondylitis.

详细描述

Lateral epicondylitis, also called tennis elbow, is the most common disease in elbow-pain symptoms. The major mechanism is overuse of the flexors, extensors and supination muscles in the wrist, causing micro-trauma in the muscles attachment to the lateral epicondyle of the elbow. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Patients often describe pain at the lateral aspect of the elbow. Pain can be further elicited with passive wrist flexion and by resisting active wrist extension. Symptoms also include weakness in the grip strength and limitation of elbow motion. Therefore, it can have a major impact on the patient's activity of daily life, including turning a doorknob, lifting a full coffee cup to mouth, or wringing out a dish rag.

Fu's subcutaneous needling (FSN), as one of the dry needle treatments, performed by swaying a disposable Fu's subcutaneous needle parallel to the underlying muscles after penetrating the skin to the subcutaneous fascia. With the reperfusion activities, myofascial pain and soft tissue pain caused by myofascial trigger points can be decreased effective simultaneously. So far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet.

The investigators will conduct the randomized experiment to evaluate the immediate, short-term, and long-term effect of FSN. The outcome measures include visual analog scale, patient-rated tennis elbow evaluation questionnaire, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluaton of the common extensor tendon.

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

入选标准

  • Subjects older than 20 years of age who can cooperate with the experimental volunteers.
  • Suffering from epicondylitis of the humerus for more than one month, and subjective pain intensity (VAS) greater than 5 points.
  • There is a local tender point at the upper elbow of the elbow, and the isometric resistance test of the forearm to make a spin will induce pain.
  • Under soft tissue ultrasound, the thickness of the common tendon of the extensor carpi muscles is more than 0.15 mm greater than that of the healthy side.

排除标准

  • There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.
  • 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 impairment, unable to cooperate with the experimenter.
  • Patients currently receiving other treatments for epicondylitis of the humerus.

研究组 & 干预措施

FSN: Fu's subcutaneous needling

Experimental

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)

TENS: Transcutaneous Electric Nerve Stimulation

Active Comparator

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

  • Pain-free grip test(1day)
  • Myotone of MTrPs(1 day)
  • Pressure Pain Threshold(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-Wei Chou

Minister of Rehabilitation

China Medical University Hospital

研究点 (2)

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