RecruitingNot ApplicableNCT05279963

EA for BPS: An RCT and Study for Central Mechanism

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

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Enrollment

84 participants

Start Date

Mar 16, 2022

Study Type

INTERVENTIONAL

Conditions

Bladder Pain Syndrome

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

≤ age ≤70 years, male or female;
Must fulfill the first and the second diagnostic criteria;
mm≤ VAS score ≤80mm;
Participants can fully understand the study protocol and a written informed consent is signed.

Exclusion Criteria7

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.

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Interventions

PROCEDUREelectroacupuncture

The prespecified acupoints applied here will include bilateral Sanyinjiao(SP6), Shenshu(BL23), Ciliao(BL32), Zhongliao(BL33), Zhibian(BL54) . Acupuncture treatment is carried out by acupuncturists who have been well trained. Acupuncture will be performed with disposable and sterile needles in the specification of 0.25 ×40 mm(diameter: 0.25mm; Suzhou Medical Products Factory Co., Ltd, China). Electroacupuncture procedures will be performed with electronic instruments (Hans-100A, Nanjing Jisheng Medical TechnologyCo., Ltd, China). Two paired of acupoints (i.e., two Shenshu(BL23) and two Ciliao(BL32), respectively) are connected to the EA apparatus. Alternating-frequency mode is selected and frequency is 2/100 Hz. EA intensity is determined in accordance with patients' endurance. EA will last for 30 min for each treatment. Patients will receive a total number of 12 EA sessions, with the frequency of 3 sessions per week for 4 weeks.

DRUGAmitriptyline

Participants in the medication group will be merely treated with oral administration of amitriptyline capsule. The dosage of amitriptyline is 25mg bid, for 4 weeks. Any changes in the medications of individual participants will be recorded on diary cards.

PROCEDUREsham electroacupuncture

In the trunk region, the points are 5 cm away from respective acupoints. In the lower limb region, the point is 3 cm away from Sanyinjiao(SP6). All points will only receive shallow insertion. Acupuncture will be performed with disposable and sterile needles in the specification of 0.25 ×40 mm(diameter: 0.25mm; Suzhou Medical Products Factory Co., Ltd, China).The needles are shallowly inserted to the subcutaneous area, and acupoints are connected to the EA apparatus without electricity. The frequency, intensity and duration of treatment will be the same as the electric needle group.