Acupuncture for Chronic Pelvic Pain

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Enrolling

Conditions

Acupuncture, Chronic Pelvic Pain, Woman

Treatments

Device: Sham Acupuncture

Device: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

2021-135-KY-01

Details and patient eligibility

About

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

Enrollment

216 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.