EA for BPS: An RCT and Study for Central Mechanism

• Status: Not yet recruiting
• Trial end date: 2025-01-23
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

Inclusion Criteria:

• 18 ≤ age ≤70 years, male or female;

• Must fulfill the first and the second diagnostic criteria;

• 30 mm≤ VAS score ≤100mm;

• Participants can fully understand the study protocol and a written informed consent is signed.

Exclusion Criteria:

• Patients with previous bladder stones or other space-occupying lesions;

• Previous positive urine culture or significant abnormal urine routine;

• Significant organic lesions of genitourinary system and pelvic organs;

• Patients suffer from severe primary diseases such as cardiovascular, cerebrovascular, respiratory, liver and kidney, or patients cannot receive EA treatment due to any reasons;

• People with heart stents and other metallic substances in their bodies;

• Women who are pregnant, planning to become pregnant, breast-feeding or allergic to study drugs;

• Patients have participated in other clinical trials within the last 3 months.