EA for BPS: an RCT and Study for Central Mechanism

NCT05279963 | Recruiting

• 1 other identifier: 2022-02-13
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Pain Syndrome

Keywords

electroacupuncture; Randomized Controlled Trial; multi-modal magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in O'Leary-Sant questionnaire from baseline to 4 weeks, 8 weeks after randomization.

  at baseline(week 0)、week 4 and week 8

• 24-hour voiding diary

  every day during the 4-week treatment phase

• Changes in Hamilton Anxiety Scale from baseline to 4 weeks, 8 weeks after randomization.

  at baseline(week 0)、week 4 and week 8

• Changes in Hamilton Depression Scale from baseline to 4 weeks, 8 weeks after randomization.

  at baseline(week 0)、week 4 and week 8

Other Outcomes (1)

• fMRI features for BPS before and after 4-week electroacupuncture treatment.

  at week 4

Study Arms (3)

medication group

ACTIVE COMPARATOR

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.

Drug: Amitriptyline

EA group

EXPERIMENTAL

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.

Procedure: electroacupuncture

SA group

SHAM COMPARATOR

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.

Procedure: sham electroacupuncture

Interventions

electroacupuncture PROCEDURE

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.

EA group

Amitriptyline DRUG

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.

medication group

sham electroacupuncture PROCEDURE

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.

SA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Electroacupuncture; Amitriptyline

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Yuanyuan Wu, PHD

CONTACT

0571-88393504; runnaway@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Chinese medicine doctor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 15, 2022
• Study Start: March 16, 2022
• Primary Completion: December 24, 2024
• Study Completion: January 23, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)