NCT05223517

Acupuncture for Chronic Pelvic Pain

Effect of Acupuncture for Chronic Pelvic Pain in Women: a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-03-06
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2022-02-04
• Last updated: 2022-03-22

Locations

1 site across 1 country: China