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EA for BPS: An RCT and Study for Central Mechanism

Primary Purpose

Bladder Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
Amitriptyline
sham electroacupuncture
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

medication group

EA group

SA group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 16, 2022
Last Updated
June 1, 2022
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05279963
Brief Title
EA for BPS: An RCT and Study for Central Mechanism
Official Title
Electroacupuncture for Bladder Pain Syndrome: An Randomized Controlled Trial and Study for Central Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
December 24, 2024 (Anticipated)
Study Completion Date
January 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Participants will be primarily recruited from gynecology, urology and acupuncture departments during outpatient service. All patients will be randomly assigned to either the medication group, EA group or SA group via random number table. SAS 9.3 software will be adopted to generate random numbers. The independent clinical research assistant will be responsible for generating random numbers and making random allocation cards, each with its group allocation information and sealed into an opaque envelope, which will not be open until the first treatment. According to the order of enrollment, eligible participants will be randomly assigned into the medication, EA or SA group at 1:2:1 ratio under the allocation in the envelope. Due to the characteristics of acupuncture, acupuncture manipulators cannot be blinded. Nevertheless, to avoid the subjective bias of researchers and subjects, outcome assessment and statistical analysis will be performed by different researchers blinded to the allocation information. Patients are informed that they will receive one of two effective acupuncture interventions after enrollment, and during the treatment, patients in EA or SA groups will be in separate rooms to avoid communication. Outcome assessors and statisticians will be blind to the group allocations. The participant's allocated intervention will not be revealed until the statistical analysis reports are completed. Participants in the medication group will be merely treated with oral administration of amitriptyline capsule. The dosage of amitriptyline is 25 mg bid, for 4 weeks. Any changes in the medications of individual participants will be recorded on diary cards. In EA group, 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: 0.25 mm; Suzhou Medical Products Factory Co., Ltd, China). Patients are asked to lie in a prone position with whole body relaxed. Both the skin around the selected acupoints and the hand of acupuncturists are routinely disinfected, after insertion, manipulations of twirling, lifting and uniform reinforcing reducing manipulation will be performed on all needles to elicit 'deqi'. The compositional sensation of 'deqi' involves with numbness, soreness, distention, aching and heaviness, which are believed to be an essential component for acupuncture efficacy. 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. In SA group, Acupuncture will be conducted by well-trained acupuncturists and performed with disposable and sterile needles in the specification of 0.25×40 mm (diameter: 0.25 mm; Suzhou Medical Products Factory Co., Ltd, China). Patients are asked to lie in a prone position with whole body relaxed. Both the skin around the selected acupoint and the hand of acupuncturists are routinely disinfected. The needles are subcutaneously inserted to non-meridian and non-acupoints regions. SA procedures will be performed with electronic instruments (Hans-100A, Nanjing Jisheng Medical Technology Co., Ltd, China). Two paired of points are connected to the electronic instruments. Alternating-frequency mode is selected and the frequency is 2/100 Hz. Different from the EA group, the apparatus will run without electricity in the SA group. The procedure will last for 30 min. Patients will receive a total number of 12 SA sessions, with the frequency of 3 sessions per week for 4 weeks. Outcomes, such as Visual analog scale, O'Leary-Sant questionnaire, 24-hour voiding diary, Hamilton Anxiety Scale and Hamilton Depression Scale, 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, and the changes of spontaneous electrical activity of specific brain regions, resting brain functional connectivity and information interaction of multifunctional areas will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Pain Syndrome
Keywords
electroacupuncture, Randomized Controlled Trial, multi-modal magnetic resonance imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Due to the characteristics of acupuncture, acupuncture manipulators cannot be blinded. Nevertheless, to avoid the subjective bias of researchers and subjects, outcome assessment and statistical analysis will be performed by different researchers blinded to the allocation information. Patients are informed that they will receive one of two effective acupuncture interventions after enrollment, and during the treatment, patients in EA or SA groups will be in separate rooms to avoid communication. The participant' s allocated intervention will not be revealed until the statistical analysis reports are completed.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
medication group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EA group
Arm Type
Experimental
Arm Description
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.
Arm Title
SA group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
electroacupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in VAS score for pain intensity from baseline to 2 weeks, 4 weeks and 8 weeks after randomization.
Description
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Time Frame
at baseline(week 0)、week 2、week 4 and week 8
Secondary Outcome Measure Information:
Title
Changes in O'Leary-Sant questionnaire from baseline to 4 weeks, 8 weeks after randomization.
Description
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.
Time Frame
at baseline(week 0)、week 4 and week 8
Title
24-hour voiding diary
Description
The frequency of urination and the special feeling during the urination will be carefully recorded every day.
Time Frame
every day during the 4-week treatment phase
Title
Changes in Hamilton Anxiety Scale from baseline to 4 weeks, 8 weeks after randomization.
Description
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.
Time Frame
at baseline(week 0)、week 4 and week 8
Title
Changes in Hamilton Depression Scale from baseline to 4 weeks, 8 weeks after randomization.
Description
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.
Time Frame
at baseline(week 0)、week 4 and week 8
Other Pre-specified Outcome Measures:
Title
fMRI features for BPS before and after 4-week electroacupuncture treatment.
Description
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.
Time Frame
at week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Wu, PHD
Phone
0571-88393504
Email
runnaway@126.com
Facility Information:
Facility Name
The Third Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Wu, Doctor
Phone
86-15336871318
Email
runnaway@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
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EA for BPS: An RCT and Study for Central Mechanism

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