EA for BPS: An RCT and Study for Central Mechanism
Status:
Not yet recruiting
Trial end date:
2025-01-23
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination