A Prospective Randomized Crossover Trial to Explore the Tolerability, Safety and Effectiveness of Chinese Herbal Medicine Among Patients With Dialysis-related Myofascial Pain
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Quality of life during dialysis
研究概览
简要总结
Dialysis-related myofascial pain in hemodialysis (HD) patients is an important issue that is associated with many other psychosomatic problems. Effective interventions are required to alleviate pain problems in this group. Chinese herbal medicine (CHM) has been tried as a potential therapeutic method to improve pain. The aim of this study is to evaluate the effect of a CHM formula intervention on pain intensity, daily function, and quality of life, and safety among HD patients in dialysis center within a southern Taiwan context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults (aged ≥ 20 y) undergoing conventional HD three times a week via an AV fistula;
- •To have myofascial trigger points (MTrPs) in one or more of the following muscles around the AV fistula: the flexor carpi radialis, palmaris longus, the pronator teres, the palmaris longus, and/or the finger flexor, diagnosed by dialysis-related myofascial pain, which must be experiencing pain during HD [M1];
- •Onset of symptoms within 1 month before enrollment;
- •Capable of giving adequate response to pain;
- •Have an exquisite tenderness was found on palpation in the taut band with moderate intensity of pain at baseline (ie, a pain score > 3 on a numeric rating scale);
- •Can commit to not change their medication and dialytic method during the 10 weeks of this study.
排除标准
- •Severe chronic or acute disease interfering with attendance for therapy;
- •Have comorbid conditions such as rheumatoid arthritis, stroke, tumor, coagulopathy, chronic liver disease, radiculopathies of the upper limb, recent history of cervical/shoulder/arm surgery, or trauma;
- •Have depression and/or presence of a psychiatric disorder;
- •Have taken painkillers, muscle relaxant, and anti-inflammatory medications or used topical anesthetics in the past week;
- •Have allergy to Chinese herbal product;
- •Unable to understand or sign an informed consent form.
研究组 & 干预措施
JBT treatment
The participants will be instructed to take their Chinese herbal medicine formula (CHM), which named Juan Bi Tang, and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.
干预措施: Chinese Herb (Drug)
结局指标
主要结局
Quality of life during dialysis
时间窗: 1 year
Kidney Disease Quality of Life 36-Item Short-Form Survey
次要结局
- Muscle power(1 year)
- Motor function of upper limb(1 year)
- Pain score during dialysis(1 year)