Actively Recruiting
EA for BPS: An RCT and Study for Central Mechanism
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2024-12-03
84
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EA for BPS: An RCT and Study for Central Mechanism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or female
- Must fulfill the first and second diagnostic criteria for bladder pain syndrome
- Visual Analog Scale (VAS) pain score between 30 mm and 80 mm
- Able to understand the study and provide written informed consent
You will not qualify if you...
- History of bladder stones or other space-occupying bladder lesions
- Previous positive urine culture or significant abnormal urine tests
- Significant organic lesions in the genitourinary or pelvic organs
- Severe primary diseases affecting cardiovascular, cerebrovascular, respiratory, liver, or kidney function
- Unable to receive electroacupuncture treatment for any reason
- Presence of heart stents or other metallic implants in the body
- Women who are pregnant, planning pregnancy, breastfeeding, or allergic to study drugs
- Participation in another clinical trial within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310053
Actively Recruiting
Research Team
Y
Yuanyuan Wu, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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