NCT05279963 EA for BPS: An RCT and Study for Central Mechanism
| NCT ID | NCT05279963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University |
| Condition | Bladder Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-03-16 |
| Primary Completion | 2024-12-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2022-03-16 with a primary completion date of 2024-12-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 18 ≤ age ≤70 years, male or female; * Must fulfill the first and the second diagnostic criteria; * 30 mm≤ VAS score ≤80mm; * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05279963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Bladder Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05279963 currently recruiting?
Yes, NCT05279963 is actively recruiting participants. Contact the research team at runnaway@126.com for enrollment information.
Where is the NCT05279963 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05279963 clinical trial?
NCT05279963 is sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. The trial plans to enroll 84 participants.