Electroacupuncture for Bladder Pain Syndrome: A Randomized Controlled Trial and Study of Central Mechanism

What this Trial Is About

Researchers are evaluating the efficacy and safety of acupuncture for treating bladder pain syndrome (BPS) in this randomized controlled trial with assessor blinding. The study compares electroacupuncture (EA) to medication with amitriptyline and a sham acupuncture group. It aims to improve symptoms such as pain, frequent urination, and emotional disorders while also exploring brain activity changes using fMRI. Participants are randomly assigned in a 1:2:1 ratio to one of three groups: medication with amitriptyline capsules taken twice daily for 4 weeks; EA treatment involving 12 sessions of acupuncture over 4 weeks with electrical stimulation at specified acupoints; or sham electroacupuncture with shallow needle insertion at non-acupoints without electrical stimulation, also for 12 sessions. Following treatment, there is a 4-week follow-up phase. Outcome assessors and statisticians are blinded, but acupuncturists and participants are aware of group assignments. Participants will be assessed at baseline, during treatment, and after follow-up using pain scales, questionnaires about urinary symptoms, 24-hour voiding diaries, and anxiety and depression scales. Brain activity will be monitored with fMRI to analyze changes in specific brain regions. The primary outcome is the change in pain intensity measured by the Visual Analog Scale at multiple timepoints. Safety and symptom changes will be closely monitored throughout the study, which lasts a total of 8 weeks for each participant.

EA for BPS: An RCT and Study for Central Mechanism