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Acupuncture for Female With Non-cyclic Chronic Pelvic Pain

NCT04553562 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-11-23

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Zhishun Liu, PhD · Guang'an men hospital, China Academy of Chinese Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-09-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553562 on ClinicalTrials.gov