Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

NCT ID: NCT04553562

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Chronic Pelvic Pain

Keywords

Acupuncture; Sham acupuncture; Randomized controlled trial; Non-cyclic chronic pelvic pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture group

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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 by the needles (0.30mm in diameter, 40 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 25-30mm. Yintang (GV4) will be inserted through the pads by the needle (0.30mm in diameter, 25mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 10-15mm. The needles at all points will be lightly lifting, thrusting, and twirling every 10 minutes during each session with the sensation of sourness, achiness, heaviness and numbness (deqi). The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.

Sham acupuncture group

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.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

Sterile adhesive pads will be placed after skin disinfection on the acupoints. Needles (0.30 mm in diameter, 25 mm in length) with a blunt tip will be inserted at the Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) without penetrating the skin. The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.

Waiting list group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

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 by the needles (0.30mm in diameter, 40 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 25-30mm. Yintang (GV4) will be inserted through the pads by the needle (0.30mm in diameter, 25mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 10-15mm. The needles at all points will be lightly lifting, thrusting, and twirling every 10 minutes during each session with the sensation of sourness, achiness, heaviness and numbness (deqi). The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.

Intervention Type: DEVICE

Sham acupuncture

Sterile adhesive pads will be placed after skin disinfection on the acupoints. Needles (0.30 mm in diameter, 25 mm in length) with a blunt tip will be inserted at the Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) without penetrating the skin. The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhishun

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu, PhD

Role: STUDY_CHAIR

Guang'an men hospital, China Academy of Chinese Medical Sciences

Central Contacts

Zhishun Liu, PhD

Role: CONTACT

Phone: 86-010-88002331

Email: liuzhishun@aliyun.com

Jing Zhou, PhD

Role: CONTACT

Phone: 86-010-15650729586

Email: zjinbj@sina.com

Other Identifiers

2019-248-KY

Identifier Type: -

Identifier Source: org_study_id