Acupuncture for Pain of Endometriosis

NCT03125304 | Completed

• 1 other identifier: jdzy2015065
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; acupuncture; pain; dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  Pelvic pain

  up to 24 weeks

Secondary Outcomes (5)

• Endometriosis Health Profile -30

  up to 24 weeks

• Multidimensional Pain Inventory

  up to 24 weeks

• Beck Depression Inventory and Profile of Mood States

  up to 24 weeks

• Patient Global Impression of Change

  up to 24 weeks

• Pain diary

  up to 24 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

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

Other: acupuncture

control group

PLACEBO COMPARATOR

Control group will receive acupuncture at non-acupoints.

Other: acupuncture

Interventions

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.

control group; treatment group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Administration of Traditional Chinese Medicine of the People's Republic of China: lead
• The Affiliated Hospital of JiangXi University of TCM: collaborator
• The Qionghai Hospital of TCM: collaborator
• The GanZhou Maternal and Child Health Hospital: collaborator
• The Second Affiliated Hospital of JiangXi University TCM: collaborator

Study Sites (1)

the second affiliated hospital of Jiangxi University of TCM

Nanchang, Jiangxi, China

Location

Related Publications (6)

• 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.

  PMID: 21442808 BACKGROUND

• 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.

  PMID: 20728977 BACKGROUND

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

  PMID: 26054137 BACKGROUND

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

  PMID: 24346786 BACKGROUND

• 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.

  PMID: 36716811 DERIVED

• 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.

  PMID: 29880009 DERIVED

MeSH Terms

Conditions

Endometriosis; Pain; Dysmenorrhea

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Pelvic Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ruining Liang

  The Second Affiliated Hospital of Jiangxi University of TCM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 24, 2017
• Study Start: May 21, 2017
• Primary Completion: March 26, 2021
• Study Completion: June 23, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

CN (1)