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临床试验/NCT03125304
NCT03125304已完成不适用

Acupuncture for Pain of Endometriosis: A Multicenter, Randomized, and Controlled Trial

State Administration of Traditional Chinese Medicine of the People's Republic of China1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Visual analogue scale

研究概览

简要总结

This proposed trial is a multicenter,randomized and controlled clinical trial. The aim of this trial is to evaluate the efficacy and safety of acupuncture for treating pain of Endometriosis.The trial period will consist of three menstrual cycles of treatment, and three menstrual cycles in the follow-up period.We put forward the following hypothesis: the effect of acupuncture group is better than the control group on relieving pain.

详细描述

Endometriosis is a kind of chronic gynaecology disease that endometrial tissue appear outside the uterine cavity , the main symptoms include dysmenorrhea, dyspareunia, chronic pelvic pain, and infertility, etc. .The secondary progressive and aggravating dysmenorrhea is thought to be the most typical symptom of endometriosis.The epidemiology data shows that about 87.7% endometriosis patients accompany with dysmenorrhea, affecting majority of women's physical and mental health and quality of life seriously .The treatment for dysmenorrhea is still the key and pressing problem of endometriosis.Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. Drug therapy mainly involves the use of oral contraceptives, progesterone and androgen derivatives, gonadotropin-releasing hormone (GnRH) agonists and aromatase inhibitors, etc.,However, in some women the side effects may not be well tolerated or the pain relief provided may be inadequate. Therefore, a large number of patients with endometriosis are turning to complementary and alternative medicine such as acupuncture.Acupuncture, as an important component of traditional Chinese medicine is widely used in Asian countries,and it can treat different diseases, including endometriosis dysmenorrhea.The analgesia principle of acupuncture is based on the theory of holistic view of zang-fu organs and meridians.In traditional Chinese medicine, dysmenorrhea is etiologically caused by the stagnated blood or Qi circulation in the uterus. The pathological factors are mostly dampness, blood stasis,and Qi obstructions. Acupuncture stimulation, which involves thrusting or twisting needles,results in various biochemical reactions that can have effects throughout the body.When the running of blood and Qi is unobstructed, pain can be relieved.However, only some small trials considered to be lacking in quality or size to guide practice.So it is urgently necessary to design multicenter ,randomized controlled trial to prove it .

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age between 20 and
  • Endometriosis diagnosed according to the Endometriosis Consensus Guidelines (Chinese Medical Association, 2015): 1) symptomatic endometriosis detected by laparoscopy or laparotomy; or 2) ovarian endometrioma detected by ultrasound or magnetic resonance imaging with pelvic pain.
  • Patients willing to receive acupuncture for pain relief.
  • Pelvic pain score equal or over 4 cm on the Visual Analogue Scale (VAS).
  • Regular menstrual cycle.
  • Signed informed consent

排除标准

  • Pelvic ultrasound demonstrates the endometrial cyst measures more than 5 cm in diameter and surgery is indicated.
  • Imaging examination suspects pelvic genital malignancies.
  • Cancer antigen-125 > 200 IU/L.
  • Pelvic infectious diseases.
  • Other severe disorders in heart, lung, liver, kidney, or mental disorders not able to cooperate in the study.
  • Patients who have received any other treatment for endometriosis that may affect the observation of the curative effects of acupuncture these three months.
  • Pregnancy or breastfeeding.
  • Refusal to be randomized.

结局指标

主要结局

Visual analogue scale

时间窗: up to 24 weeks

Pelvic pain

次要结局

  • Patient Global Impression of Change(up to 24 weeks)
  • Pain diary(up to 24 weeks)
  • Multidimensional Pain Inventory(up to 24 weeks)
  • Endometriosis Health Profile -30(up to 24 weeks)
  • Beck Depression Inventory and Profile of Mood States(up to 24 weeks)

研究者

发起方
State Administration of Traditional Chinese Medicine of the People's Republic of China
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Liang Ruining

Professor

Jiangxi University of Traditional Chinese Medicine

研究点 (1)

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