EA for BPS: An RCT and Study for Central Mechanism

This is a randomized controlled and assessor-blinded design trial to evaluate the efficacy and safety of acupuncture for bladder pain syndrome(BPS). All eligible participants will be randomly assigned to the medication group(n=21), EA group(n=42) and SA group(n=21) in a 1:2:1 allocation ratio. Participants will receive 4-week treatments phase followed by a 4-week follow-up phase. Outcomes will be assessed at baseline, during the treatment and at the end of the follow-up. Outcome assessors, data managers and statisticians will be blinded to the group allocation, while acupuncturists and participants will not be blinded for obvious reasons. Besides, fMRI will be used to collect spontaneous electrical activity of the brain of patients. In this trial, the investigators assume that electroacupuncture for BPS, compared to amitriptyline, is instrumental in improving symptoms such as pain, frequent micturition and emotional disorder.

NCT Number	NCT05279963
Lead Sponsor	The Third Affiliated hospital of Zhejiang Chinese Medical University
Conditions	Bladder Pain Syndrome
Enrollment	84 participants
Start Date	2022-03-16
Primary Completion	2024-12-24 (estimated)
Study Completion	2025-01-23 (estimated)
Updated on ClinicalTrials.gov	2024-12-03