Effect on Symptomatic Release of Remote Fu's Subcutaneous Needling on Patients With Biceps Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Visual Analog Scales
研究概览
简要总结
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles.We will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of Fu's subcutaneous needling (FSN).
详细描述
Biceps tendinopathy is a common cause in shoulder-pain symptoms. The major mechanism is overuse of the biceps muscles. The long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. Common symptoms are pain in the anterior shoulders and radiating pain in the biceps. Pain can be further elicited with lifting, pulling and repetitive overhead activity. Therefore, it can have a major impact on the patient's activity of daily life.
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.
We will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of FSN. Outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, muscle tone changes and ultrasonographic evaluaton of biceps peritendinous effusion.
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
- •Subjects older than 20 years of age who can cooperate with the experimental volunteers.
- •Suffering from biceps tendon lesions for more than one month, and subjective pain intensity (VAS) greater than 5 points.
- •There is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain.
- •Under soft tissue ultrasound, the thickness of biceps peritendinous effusion (BPE) on the affected side of the biceps tendon is greater than1 mm.
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 shoulder, neck or upper back surgery.
- •People with central or peripheral nerve disease.
- •Cognitive impairment, unable to cooperate with the experimenter.
- •Patients currently receiving other treatments for biceps tendinopathy.
- •Patients receiving shoulder injection treatments within the last 6 months.
- •Patients with rheumatic diseases.
结局指标
主要结局
Visual Analog Scales
时间窗: before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately
The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. This tool used to help a person rate the intensity of certain sensations and feelings, such as pain. A straight line of 100mm is actually marked with 0 mm on the far left and 100mm on the far right. Two faces are drawn on both ends. Explain to the patient that 0 mm means no pain and 100 mm means very painful. From the left end, the right shift indicates more and more pain. The evaluator will let the patient draw a short line vertically on the line,representing his painful position, and record the measured cm value. In this test, if the score of the subject decreases,it can represent the treatment is helpful for the improvement of the patient's pain.
次要结局
- Pressure Pain Threshold(before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately)
- Ultrasonographic evaluaton of biceps peritendinous effusion(before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately)
- Muscle tension(before and after Day1, Day2, Day4 treatment ; on Day8 and Day 15 separately)
- Shoulder pain and disability index (SPADI)(before and after Day1, Day2, Day4 treatment ; on Day8 and Day15 separately)
研究者
Li-Wei Chou
Minister of Rehabilitation
China Medical University Hospital