Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial

Ruining Liang, Peishuang Li, Xuemei Peng, Ling Xu, Pei Fan, Jiahua Peng, Xu Zhou, Chunlin Xiao, Miao Jiang
Trials · 2018 · vol. 19(1) , pp. 314 · doi:10.1186/s13063-018-2684-6 · PMID:29880009 · W2805536331
article OA: gold CC0 ⤵ 11 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This randomized, placebo-controlled trial will investigate the efficacy and safety of acupuncture at specific acupoints compared to non-acupoints for treating pelvic pain in patients with endometriosis.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-09 ⓘ

This paper describes a randomized, single-blind, multi-center, placebo-controlled trial to evaluate the efficacy and safety of acupuncture for pelvic pain related to endometriosis. The study will enroll 106 women aged 20–40 years with endometriosis diagnosed by laparoscopy/laparotomy or imaging, randomized 1:1 to receive acupuncture at specified acupoints (with manual stimulation to evoke De Qi) or acupuncture at non-acupoints, with treatment across three menstrual cycles and a three-cycle follow-up period; the primary outcome is pelvic pain measured on a 10-cm visual analog scale, with additional quality-of-life and psychological questionnaires. The protocol notes that prior evidence for acupuncture in endometriosis pain has been limited and that quality of evidence across comparisons in related reviews has ranged from very low to moderate, though this trial’s main methodological limitation is that it is a protocol paper and does not yet report results. This paper is centrally about endometriosis — it specifically outlines a trial of acupuncture to reduce endometriosis-associated pelvic pain and assess safety.

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Abstract

BACKGROUND: Endometriosis is a chronic gynecological disease that is characterized by the presence of endometrial tissue outside the uterine cavity. The main symptoms include dysmenorrhea, dyspareunia, chronic pelvic pain, and infertility. These symptoms impair the lives of most of the women suffering from the disease. Surgical resection of endometriotic lesions is an effective means of treating dysmenorrhea, but the risk of recurrence is high. Western medicine has limited use for treating it due to side effects and ineffectiveness. The purpose of this study is to verify the effectiveness and safety of acupuncture. METHODS/DESIGN: This trial will be carried out in four parts. A total of 106 eligible patients with pelvic pain related to endometriosis will be randomly assigned into two groups, in a 1:1 ratio, as the treatment group or the control group. The participants assigned to the treatment group will be treated with acupuncture treatment at Guanyuan (CV4), Sanyinjiao (SP6), Taichong (LR3), Zhaohai (KI6) and Qichong (ST30) while the control group will receive acupuncture at non-acupoints. The trial will include three menstrual cycles of treatment and three menstrual cycles of follow-up. The primary outcome is pelvic pain that will be assessed by means of a 10-cm visual analog scale (VAS). At each stage, we will evaluate the safety of the acupuncture treatment. DISCUSSION: The study will compare the effectiveness and safety of acupuncture with comfort needles on pelvic pain related to endometriosis in the hope of providing significant evidence for using acupuncture on pelvic pain related to endometriosis. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03125304 . Registered on 30 April 2017.

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Outcome instruments

VAS-pain

Condition tags

mesh:D004715mesh:D017699endometriosischronic_pelvic_paindysmenorrheadyspareuniainfertility

MeSH descriptors

Acupuncture Therapy Acupuncture Therapy Endometriosis Pelvic Pain Adult China Endometriosis Endometriosis Female Humans Multicenter Studies as Topic Pain Measurement Pelvic Pain Pelvic Pain Pelvic Pain Randomized Controlled Trials as Topic Single-Blind Method Time Factors Treatment Outcome Young Adult

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

References (26)

Cited by (11)

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