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Acupuncture for Pain of Endometriosis

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ClinicalTrials.gov Identifier: NCT03125304
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : March 22, 2018
Sponsor:
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

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 .

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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

Resource links provided by the National Library of Medicine


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.




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



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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.

Information from the National Library of Medicine

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


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

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