Acupuncture for Pain of Endometriosis

• Sponsor: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Collaborators: The Second Affiliated Hospital of JiangXi University TCM; The Affiliated Hospital of JiangXi University of TCM; The Qionghai Hospital of TCM; The GanZhou Maternal and Child Health Hospital
• Information provided by (Responsible Party): Liang Ruining, State Administration of Traditional Chinese Medicine of the People's Republic of China

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Endometriosis	Other: acupuncture	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	106 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	The participants assigned to the treatment groups will receive acupuncture at Sanyinjiao (SP 6), Zhaohai (KI 6) ,Taichong (LR 3) ,Qichong (ST 30) and Guanyuan (CV4), while the control group will receive acupuncture at non-acupoint.
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Acupuncture for Pain of Endometriosis: A Multicenter, Randomized, and Controlled Trial
Actual Study Start Date :	May 21, 2017
Estimated Primary Completion Date :	April 30, 2020
Estimated Study Completion Date :	May 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Visual analogue scale [ Time Frame: up to 24 weeks ]
   Pelvic pain

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Contacts

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Contact: Ruining Liang	8615979172105	jack@sina.com

Locations

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China, Jiangxi
the second affiliated hospital of Jiangxi University of TCM	Recruiting
Nanchang, Jiangxi, China
Contact: Ruining Liang 8615979172105 jack@sina.com

Sponsors and Collaborators

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

The Second Affiliated Hospital of JiangXi University TCM

The Affiliated Hospital of JiangXi University of TCM

The Qionghai Hospital of TCM

The GanZhou Maternal and Child Health Hospital

Investigators

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Study Director:	Ruining Liang	the second affiliated hospital of Jiangxi University of TCM

More Information

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.

Magalhães J. Acupuncture for pain in endometriosis. Sao Paulo Med J. 2013;131(6):439. doi: 10.1590/1516-3180.20131316T1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Liang Ruining, Professor, State Administration of Traditional Chinese Medicine of the People's Republic of China
ClinicalTrials.gov Identifier:	NCT03125304 History of Changes
Other Study ID Numbers:	jdzy2015065
First Posted:	April 24, 2017
Last Update Posted:	March 22, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Liang Ruining, State Administration of Traditional Chinese Medicine of the People's Republic of China:

Endometriosis; acupuncture; pain; dysmenorrhea

Additional relevant MeSH terms:

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Endometriosis; Genital Diseases, Female