Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

Last updated: November 20, 2021
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Interstitial Cystitis

Dysmenorrhea (Painful Periods)

Chronic Pelvic Pain

Treatment

N/A

Clinical Study ID

NCT04553562
2019-248-KY
  • Ages 18-50
  • Female

Study Summary

Chronic pelvic pain (CPP) is one of the common symptoms of women at childbearing age. The aim of this study is to assess the efficacy of acupuncture for female with non-cyclic chronic pelvic pain. A three-arm randomized controlled trial (RCT) using acupuncture, sham acupuncture and waiting list with a total sample of 150 will be conducted.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the diagnostic criteria of non-cyclic CPP.
  • Age 18 to 50 years.
  • Have moderate to severe pain in pelvis, anterior abdominal wall, lower back, orbuttocks lasting at least six months.
  • The mean degree of pelvic pain in the past week rated by Visual Analogue Scale is ≥40scores.
  • Sign informed consent and participate in the study voluntarily.

Exclusion

Exclusion Criteria:

  • Have endometriosis (including adenomyosis), ovarian cyst (larger than 3cm),hysteromyoma (larger than 3cm), severe pelvic adhesion, pelvic malignant tumor (relevant examination must be within the last 6 months).
  • Have acute pelvic/urinary tract infection.
  • Have pain after pelvic surgery.
  • Have recurrent gastrointestinal or bladder diseases such as irritable bowel syndrome,interstitial cystitis / bladder pain syndrome, etc.
  • During pregnancy or in lactation or have a pregnancy plan within 8 months.
  • Have heart, lung, liver, kidney, mental disorders or cognitive dysfunction.
  • Have acupuncture treatment in recent 3 months.

Study Design

Total Participants: 150
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2023

Study Description

Chronic pelvic pain (CPP) is a persistent pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months. According to a WHO epidemiological study, the worldwide prevalence rate of CPP in childbearing age women was 2.1%-24%. At present, nearly 55% of the patients had unclear etiology, and there is no universally accepted diagnosis, evaluation and treatment. CPP is often associated with gynecological and non gynecological diseases, including endometriosis, abdominal visceral adhesion, myofascial pain and dysfunction, irritable bowel syndrome and interstitial cystitis/bladder pain syndrome. CPP are also accompanied by psychological and physiological dysfunction, the most common is depression and anxiety, which seriously affects the quality of life of patients.

Acupuncture may have effect on non-cyclic CPP in female, however, there is a lack of evidence of effectiveness of acupuncture. A multi-center randomized three-armed controlled trial will be conducted. The aim of this study is assess the efficacy and safety of acupuncture for female patients with non-cyclic CPP.