ChiCTR2000034783尚未招募Unknown
Clinical Study on Treatment of Non-acute Knee Osteoarthritis (KOA) Using Electro-acupuncture at Top Ten High-selected Acupoints
UTAR Research Fund 2019 Cycle 12 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年11月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- clinical comprehensive efficacy evaluation score
研究概览
简要总结
- To study the Traditional Chinese Medicine theory of acupuncture for Knee Osteoarthritis (KOA), and find out the regular rules of choosing the acupoints to treat this disease through literature research.
- Comparing the application of electro-acupuncture and traditional acupuncture in the treatment of patients who are suffering the non-acute KOA and observing, recording and analyzing the changes of the clinical symptoms and the clinical observation indicators as WOMAC, Lysholm knee scoring scale (LKSS), VAS score and clinical comprehensive efficacy evaluation score, to evaluate the clinical efficacy of electro-acupuncture combined with the top ten high-selected acupoints on the KOA.
- By measuring the levels of IL-1β and TNF-α changes in patients serum before and after treatment, analyze and explore some possible internal mechanisms about acupuncture that can improve patients' clinical symptoms and treat KOA.
- To find out and introduce a more effective, and easier to promote KOA acupuncture treatment plan, through this research, as a result of bringing the benefits to patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 45 至 80（—）
- 性别
- All
入选标准
- •Patients are not suffering rheumatoid arthritis (RA), the results of the laboratory tests for rheumatoid factors are negative;
- •The patients are not in the acute phase of knee osteoarthritis and have not been accompanied by inflammatory lesions in the past two weeks, not taken antibiotics or hormonal drugs in the past two weeks;
- •Aged 45 to 80 years old;
- •Patients who meet the above diagnostic criteria;
- •Did not receive other related treatments within 1 month (or treatments that may affect the observation of the efficacy indicators of the study);
- •Can accept and adhere to the whole course of treatment;
- •The localized skin of the knee joint is intact;
- •Voluntary signing Informed consent and risk notification for acupuncture treatment of KOA.
排除标准
- •Those who do not meet the diagnostic criteria and the inclusion criteria;
- •Patients who have another relevant history of joint diseases, such as rheumatism, rheumatoid, gout disease, and any other type of arthritis or other knee painful diseases;
- •The patients are in the acute phase of knee osteoarthritis and have been accompanied by inflammatory lesions in the past two weeks, taken antibiotics or hormonal drugs in the past two weeks;
- •Visual analogue scale (VAS) <=3;
- •Knee joint disease caused by trauma, or local skin of the knee joint damage or with inflammation;
- •Blood, kidney, liver, and metabolic dysfunction. Or with mental illness or tumor;
- •Patients with systemic or local infections or infectious diseases;
- •Pregnancy or lactation women. And anyone with a cardiac pacemaker or any metal object in the body.
- •Patients with the symptoms of allergies, gastrointestinal discomfort, and other symptoms.
- •Researchers believe there are other reasons that are not suitable for clinical trials.
- •Patients who do not cooperate with follow-up work.
研究组 & 干预措施
Experimental group
electro-acupuncture with the top ten high-selected acupoints
control group 1
traditional acupuncture with the top ten high-selected acupoints
control group 2
electro-acupuncture with the acupoints not belonging to the main meridians
结局指标
主要结局
clinical comprehensive efficacy evaluation score
Level of IL-1beta and TNF-alpha in patients' serum
次要结局
- Western Ontario and McMaster University Osteoarthritis Index score (WOMAC)
- Lysholm knee scoring scale (LKSS)
- Visual Analogue Score/Scale (VAS)
研究者
研究点 (2)
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