Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Chronic Pelvic Pain

Treatments: Device: Sham acupuncture; Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04553562

2019-248-KY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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, or buttocks lasting at least six months.
• The mean degree of pelvic pain in the past week rated by Visual Analogue Scale is ≥40 scores.
• Sign informed consent and participate in the study voluntarily.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Acupuncture group

Experimental group

Description:

For acupuncture group, sterile adhesive pads will be placed after skin disinfection on the acupoints. Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) will be inserted through the pads. The participants will be treated three times a week, on alternate days, for 6 successive weeks; 18 sessions for each patient in total.

Treatment:

Device: Acupuncture

Sham acupuncture group

Sham Comparator group

Description:

For the sham acupuncture group, aterile adhesive pads will be placed after skin disinfection on the acupoints and needles with a blunt tip will be inserted at the same acupoints in the acupuncture group without penetrating the skin.No manipulation of needles will be conducted. The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.

Treatment:

Device: Sham acupuncture

Waiting list group

No Intervention group

Description:

For the waiting list group, patients will receive no treatment in the first 6 weeks and will receive the same treatment used in the acupuncture group according to patients' preference.