Acupuncture for Chronic Pelvic Pain

NCT05223517 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-03-22

No results posted yet for this study

Summary

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

Conditions

  • Acupuncture, Chronic Pelvic Pain, Woman

Interventions

DEVICE

Acupuncture

Hwato brand disposable acupuncture needles (size 0.30 × 40 mm and 0.30 × 75 mm) and adhesive pads will be used. Acupoints of Ciliao, Huiyang, Shenshu, Guanyuan, Shuidao, Sanyinjiao, Zusanli, Taixi, Hegu, and Taichong will be used for every participants. Those with sleep or mood disorders will also use acupoints of Shangyintang, Shenmen and Neiguan. Those with tenderness points on the abdominal wall will also use Ashi points no more than five. The needles will be inserted to 60-70mm in Ciliao and Huiyang, 6-10 mm in Shenmen and 10-20mm in other acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times (except for Ciliao) to achieve deqi sensation and manipulated every ten minutes during 20-minute maintenance in prone and supine position respectively. Participants receive acupuncture treatment three times a week in the first four weeks and twice a week in the last four weeks.

DEVICE

Sham Acupuncture

Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Ciliao, Huiyang, Shenshu, Guanyuan, Shuidao, Sanyinjiao, Zusanli, Taixi, Hegu, and Taichong will be used for every participants. Those with sleep or mood disorders will also use acupoints of Shangyintang, Shenmen and Neiguan. Those with tenderness points on the abdominal wall will also use Ashi points no more than five. The needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrusted and twirled gently for 3 times to mimic real acupuncture. No manipulation will be conducted during 20-minute maintenance in prone and supine position respectively. Participants receive sham acupuncture treatment three times a week in the first four weeks and twice a week in the last four weeks.

Sponsors & Collaborators

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

    lead OTHER

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
2022-03-06
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT05223517 on ClinicalTrials.gov