Acupuncture for Pain of Endometriosis

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Other: acupuncture

Detailed Description

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 .

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Jiangxi University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria

1. Women age between 20 and 40.
2. 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.
3. Patients willing to receive acupuncture for pain relief.
4. Pelvic pain score equal or over 4 cm on the Visual Analogue Scale (VAS).
5. Regular menstrual cycle.
6. Signed informed consent

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Treatment group will receive acupuncture at Sanyinjiao (SP 6), Zhaohai (KI 6) ,Taichong (LR 3) ,Qichong (ST 30) and Guanyuan.	Other: acupuncture; 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.
Placebo Comparator: control group; Control group will receive acupuncture at non-acupoints.	Other: acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	Pelvic pain	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis Health Profile -30	Endometriosis-specific quality of life	up to 24 weeks
Multidimensional Pain Inventory	Physical functioning	up to 24 weeks
Beck Depression Inventory and Profile of Mood States	Emotional functioning	up to 24 weeks
Patient Global Impression of Change	Patient satisfaction	up to 24 weeks
Pain diary	the specific time and frequency of pain attacks, the duration of pain	up to 24 weeks

Collaborators and Investigators

• Sponsor: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Collaborators: The Affiliated Hospital of JiangXi University of TCM; The Qionghai Hospital of TCM; The GanZhou Maternal and Child Health Hospital; The Second Affiliated Hospital of JiangXi University TCM
• Investigators: Study Director: Ruining Liang, The Second Affiliated Hospital of Jiangxi University of TCM

Publications and helpful links

General Publications

• Xiang DF, Sun QZ, Liang XF. [Effect of abdominal acupuncture on pain of pelvic cavity in patients with endometriosis]. Zhongguo Zhen Jiu. 2011 Feb;31(2):113-6. Chinese.
• Rubi-Klein K, Kucera-Sliutz E, Nissel H, Bijak M, Stockenhuber D, Fink M, Wolkenstein E. Is acupuncture in addition to conventional medicine effective as pain treatment for endometriosis? A randomised controlled cross-over trial. Eur J Obstet Gynecol Reprod Biol. 2010 Nov;153(1):90-3. doi: 10.1016/j.ejogrb.2010.06.023. Epub 2010 Aug 21.
• Zhang X, Li W. [Efficacy on endometriosis treated with electroacupuncture]. Zhongguo Zhen Jiu. 2015 Apr;35(4):323-6. Chinese.
• Magalhaes J. Acupuncture for pain in endometriosis. Sao Paulo Med J. 2013;131(6):439. doi: 10.1590/1516-3180.20131316T1. No abstract available.
• Liang R, Li P, Peng X, Xu L, Fan P, Peng J, Zhou X, Xiao C, Jiang M. Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial. Trials. 2018 Jun 7;19(1):314. doi: 10.1186/s13063-018-2684-6.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2017
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): June 23, 2021

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pain; acupuncture; Endometriosis; dysmenorrhea
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: jdzy2015065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No