Bladder Pain Syndrome Clinical Trial
Official title:
Electroacupuncture for Bladder Pain Syndrome: An Randomized Controlled Trial and Study for Central Mechanism
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.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | January 23, 2025 |
Est. primary completion date | December 24, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The Third A?liated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Third Affiliated hospital of Zhejiang Chinese Medical University |
China,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | at week 4 | |
Primary | 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. | at baseline(week 0)?week 2?week 4 and week 8 | |
Secondary | 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. | at baseline(week 0)?week 4 and week 8 | |
Secondary | 24-hour voiding diary | The frequency of urination and the special feeling during the urination will be carefully recorded every day. | every day during the 4-week treatment phase | |
Secondary | 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. | at baseline(week 0)?week 4 and week 8 | |
Secondary | 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. | at baseline(week 0)?week 4 and week 8 |
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