Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

NCT04553562 | Unknown DMC

• 1 other identifier: 2019-248-KY
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pelvic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The change from baseline of the mean score in the past week of the Visual Analogue Scale

  The scores of the Visual Analogue Scale range from 0 to 10，higher scores mean a worse outcome.

  Week 6, 18 and 30

Secondary Outcomes (10)

• The change from baseline of the Brief Pain Inventory score

  Week 6, 18 and 30

• The change from baseline of the pain severity score of the Brief Pain Inventory

  Week 6, 18 and 30

• The change from baseline of the pain interference score of the Brief Pain Inventory

  Week 6, 18 and 30

• The proportion of patients with decrease of 0.6 score or more from baseline of the pain interference score of the Brief Pain Inventory

  Week 6, 18 and 30

• The proportion of patients with decrease of 20% or more from baseline of the pain severity score of the Brief Pain Inventory

  Week 6, 18 and 30

Other Outcomes (4)

• Blinding assessment

  Week 6

• Safety assessment

  Week 0 to 30

• Expectation of improvement assessment

  Baseline

Study Arms (3)

Acupuncture group

EXPERIMENTAL

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.

Device: Acupuncture

Sham acupuncture group

SHAM COMPARATOR

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.

Device: Sham acupuncture

Waiting list group

NO INTERVENTION

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.

Interventions

Acupuncture 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.

Acupuncture group

Sham acupuncture 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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhishun Liu, PhD

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

  STUDY CHAIR

Central Study Contacts

Zhishun Liu, PhD

CONTACT

86-010-88002331; liuzhishun@aliyun.com

Jing Zhou, PhD

CONTACT

86-010-15650729586; zjinbj@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants in the acupuncture and sham acupuncture will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 17, 2020
• Study Start: December 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2023
• Last Updated: November 23, 2021

Record last verified: 2021-11