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Acupuncture for Pain of Endometriosis

NCT ID: NCT03125304

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-21

Study Completion Date

2021-06-23

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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treatment group

Treatment group will receive acupuncture at Sanyinjiao (SP 6), Zhaohai (KI 6) ,Taichong (LR 3) ,Qichong (ST 30) and Guanyuan.

Group Type EXPERIMENTAL

acupuncture

Intervention Type 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.

control group

Control group will receive acupuncture at non-acupoints.

Group Type PLACEBO_COMPARATOR

acupuncture

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of JiangXi University of TCM

UNKNOWN

Sponsor Role collaborator

The Qionghai Hospital of TCM

UNKNOWN

Sponsor Role collaborator

The GanZhou Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of JiangXi University TCM

UNKNOWN

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Liang Ruining

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruining Liang

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Jiangxi University of TCM

Locations

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the second affiliated hospital of Jiangxi University of TCM

Nanchang, Jiangxi, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 21442808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20728977 (View on PubMed)

Zhang X, Li W. [Efficacy on endometriosis treated with electroacupuncture]. Zhongguo Zhen Jiu. 2015 Apr;35(4):323-6. Chinese.

Reference Type BACKGROUND
PMID: 26054137 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24346786 (View on PubMed)

Li PS, Peng XM, Niu XX, Xu L, Hung Yu Ng E, Wang CC, Dai JF, Lu J, Liang RN. Efficacy of acupuncture for endometriosis-associated pain: a multicenter randomized single-blind placebo-controlled trial. Fertil Steril. 2023 May;119(5):815-823. doi: 10.1016/j.fertnstert.2023.01.034. Epub 2023 Jan 27.

Reference Type DERIVED
PMID: 36716811 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29880009 (View on PubMed)

Other Identifiers

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jdzy2015065

Identifier Type: -

Identifier Source: org_study_id