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.
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.
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;
Parallel
electroacupuncture
Procedure/SurgeryThe 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.
Amitriptyline
DrugParticipants 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.
sham electroacupuncture
Procedure/SurgeryIn 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.
Changes in VAS score for pain intensity from baseline to 2 weeks, 4 weeks and 8 weeks after randomization.
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Changes in O'Leary-Sant questionnaire from baseline to 4 weeks, 8 weeks after randomization.
O'Leary-Sant questionnaire include interstitial cystitis Inflammation Index (ICSI) and interstitial Cystitis Problems Index (ICPI). Both ICSI and ICPI contain 4 questions. ICSI mainly assesses the severity of symptoms and every item estimation score ranges between 0 and 5. The total score ranges from 0 to 20 and higher scores indicate more severe symptoms. ICPI evaluates the degree of distress to the patient and every item estimation score ranges from 0 to 4. The total score ranges from 0 to 16; higher score represent, the more serious the distress.
24-hour voiding diary
The frequency of urination and the special feeling during the urination will be carefully recorded every day.
Changes in Hamilton Anxiety Scale from baseline to 4 weeks, 8 weeks after randomization.
Hamilton Anxiety Scale is represented by 14 items. Every item estimation score ranges between 0 and 4. The total score ranges from 0 to 56. Higher the score, severe the situation. In this scale, score 7-14 indicates mild severity, 15-21 represents mild to moderate severity, 22-28 represents moderate severity, and \>28 indicates severe condition.
Changes in Hamilton Depression Scale from baseline to 4 weeks, 8 weeks after randomization.
Hamilton Depression Scale is is composed of 17 questions. The total score ranges from 0 to 53. The higher the score, the more depressed the patient. In this scale, score 8-16 indicates mild severity, 17-23 represents mild to moderate severity, and 24-53 refers moderates to severe condition.
fMRI features for BPS before and after 4-week electroacupuncture treatment.
Using BOLD-fMRI at resting-state and diffusion tensor imaging, altered fMRI features in brain for BPS patients will be identified before and after 4-week electroacupuncture treatment.
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