Status:

UNKNOWN

Acupuncture for Chronic Pelvic Pain

Lead Sponsor:

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Conditions:

Acupuncture, Chronic Pelvic Pain, Woman

Eligibility:

FEMALE

18-50 years

Phase:

NA

Brief Summary

The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.

Eligibility Criteria

Inclusion

  • Female patients aged between 18 and 50.
  • Chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 6 months duration.
  • Having not used medications, other than rescue medicine, or therapies for chronic pelvic pain for at least 4 weeks before randomization, and consenting not to use throughout the process of the research.
  • Completing Weekly Pain Diary for at least three week during the four-week run-in period, and at least two of the worst pain scoring ≥4 on the Numeric Rating Scale.
  • Volunteering to participate the trial and signing written informed consent.

Exclusion

  • Cyclical chronic pelvic pain, such as only with dysmenorrhea.
  • Endometriosis.
  • Adenomyosis.
  • Complex ovarian cyst.
  • Accessory cyst \>5cm.
  • Uterine fibroids \>5cm.
  • Malignant disease.
  • Anterior sacral neurectomy or uterine sacral nerve ablation before or scheduled in the next 6 month.
  • Irritable bowel syndrome.
  • Symptomatic urinary tract infection.
  • Acute pelvic inflammation.
  • Uncontrolled vaginitis.
  • Lactation period, pregnancy, or fetation planned in the next 6 months.
  • Sever disorders in heart, lung, brain, liver, kidney and hematopoietic system, or obvious psychiatric or cognitive dysfunction.
  • Poor adherence.

Key Trial Info

Start Date :

March 6 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

216 Patients enrolled

Trial Details

Trial ID

NCT05223517

Start Date

March 6 2022

End Date

December 1 2024

Last Update

March 22 2022

Active Locations (1)

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1

China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China, 100053