Skip to main content
OpenTrials
Completed

NCT Number: NCT03125304

Acupuncture for Pain of Endometriosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

the second affiliated hospital of Jiangxi University of TCM

Nanchang, Jiangxi, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women age between 20 and 40.
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Acupuncture

Other

They will be treated seven days before expected menstrual onset with once a day and three times a week for therapy. During the menstrual period,they will be treated everyday when they are having pain.Every treatment lasts 30 minutes. The trial period will consist of three menstrual cycles of treatment and three menstrual cycles in the follow-up period.

Primary outcomes

  1. Visual analogue scale

    Time frame: up to 24 weeks

    Pelvic pain

Secondary outcomes

  1. Endometriosis Health Profile -30

    Time frame: up to 24 weeks

    Endometriosis-specific quality of life

  2. Multidimensional Pain Inventory

    Time frame: up to 24 weeks

    Physical functioning

  3. Beck Depression Inventory and Profile of Mood States

    Time frame: up to 24 weeks

    Emotional functioning

  4. Patient Global Impression of Change

    Time frame: up to 24 weeks

    Patient satisfaction

  5. Pain diary

    Time frame: up to 24 weeks

    the specific time and frequency of pain attacks, the duration of pain

Sponsors and collaborators

Lead sponsor

State Administration of Traditional Chinese Medicine of the People's Republic of China

Other Gov

Collaborators

  • The Affiliated Hospital of JiangXi University of TCM
  • The GanZhou Maternal and Child Health Hospital
  • The Qionghai Hospital of TCM
  • The Second Affiliated Hospital of JiangXi University TCM

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2017
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.