NCT05548374

Acupuncture for Breast Pain

The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.

Conditions

• Acupuncture
• Mastodynia

Interventions

Type	Name	Description
DEVICE	Acupuncture	The acupoints of Shangyintang, Danzhong(RNl7), Jvque(RN14), Liangmen(ST21), Zhongwan(RNl2), Hegu(LI4), Waiguan(SJ5), Zusanli(ST36), Sanyinjiao(SP6), Taichong(LR3) are selected as main acupoints and used per treatment. The other three acupoints will be chosen one each session according to the syndrome differentiation: Taixi (KI3) for liver and kidney deficiency, Fenglong (ST40) for spleen deficiency and phlegm coagulation, and Xuehai (SP10) for qi-stagnation and blood-stasis. Sterile adhesive pads will be placed on the acupoints after skin disinfection. Hwato-brand disposable acupuncture needles (size 0.30×40mm) will be inserted into the acupoints through the adhesive pads. Afterwards, the acupuncture will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance.
DEVICE	Sham acupuncture	The acupoints of Shangyintang, Danzhong(RNl7), Jvque(RN14), Liangmen(ST21), Zhongwan(RNl2), Hegu(LI4), Waiguan(SJ5), Zusanli(ST36), Sanyinjiao(SP6), Taichong(LR3) are selected as main acupoints and used per treatment. The other three acupoints will be chosen one each session according to the syndrome differentiation: Taixi (KI3) for liver and kidney deficiency, Fenglong (ST40) for spleen deficiency and phlegm coagulation, and Xuehai (SP10) for qi-stagnation and blood-stasis. Sterile adhesive pads will be placed on the acupoints after skin disinfection. The needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) 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 30-minute maintenance.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-31
• Completion: 2024-09-30
• First posted: 2022-09-21
• Last updated: 2023-02-28

Locations

1 site across 1 country: China