EA for BPS: An RCT and Study for Central Mechanism
Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Bladder Pain Syndrome focused on measuring electroacupuncture, Randomized Controlled Trial, multi-modal magnetic resonance imaging
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.
Sites / Locations
- The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Sham Comparator
medication group
EA group
SA group
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 participants will be recorded on diary cards.
Patients allocated to this group will receive treatment with electroacupuncture. The location of acupoints will be determined based on the National Standard Nomenclature and Location of Acupoints. Patients will receive a total number of 12 EA sessions, with the frequency of 3 sessions per week for 4 weeks.
Patients allocated to this group will receive acupuncture in non-meridian and non-acupoints regions. 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 EA group.