Acupuncture for Pain of Endometriosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03125304 |
Recruitment Status :
Completed
First Posted : April 24, 2017
Last Update Posted : October 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis | Other: acupuncture | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | March 26, 2021 |
Actual Study Completion Date : | June 23, 2021 |

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. |
- Visual analogue scale [ Time Frame: up to 24 weeks ]Pelvic pain
- Endometriosis Health Profile -30 [ Time Frame: up to 24 weeks ]Endometriosis-specific quality of life
- Multidimensional Pain Inventory [ Time Frame: up to 24 weeks ]Physical functioning
- Beck Depression Inventory and Profile of Mood States [ Time Frame: up to 24 weeks ]Emotional functioning
- Patient Global Impression of Change [ Time Frame: up to 24 weeks ]Patient satisfaction
- Pain diary [ Time Frame: up to 24 weeks ]the specific time and frequency of pain attacks, the duration of pain

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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 |
Inclusion criteria
- 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
Exclusion criteria
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125304
China, Jiangxi | |
the second affiliated hospital of Jiangxi University of TCM | |
Nanchang, Jiangxi, China |
Study Director: | Ruining Liang | The Second Affiliated Hospital of Jiangxi University of TCM |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Liang Ruining, Professor, Jiangxi University of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT03125304 |
Other Study ID Numbers: |
jdzy2015065 |
First Posted: | April 24, 2017 Key Record Dates |
Last Update Posted: | October 19, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Endometriosis acupuncture pain dysmenorrhea |
Endometriosis |