Auricular Acupressure Therapy for Patients With IC/BPS

NCT ID: NCT05857020

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-10-31

Brief Summary

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The purpose of this study is to determine the feasibility of administering auricular acupressure for patients with interstitial cystitis/bladder pain syndrome (IC/BPS), and evaluating the efficacy of auricular acupressure to reduce pain scores and decrease pain medication usage over time.

Detailed Description

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Eligible participants will be asked to complete baseline questionnaires. After completion, a study interventionist will place 10 adhesive acupressure pads/seeds on the participant's ears (5 on each ear). Each seed will be placed on a specific site on the ear believed to help with pain and overall well-being. Over the course of 5 days, participants will be asked to apply a small amount of manual pressure with their fingers to each of the ear pads and answer daily study questionnaires.

This feasibility trial is being conducted in collaboration with the Battlefield Auricular Acupressure (BAApress) Training and Intervention Fidelity study (IRB00084011).

Conditions

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Interstitial Cystitis Bladder Pain Syndrome Urologic Diseases Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Any patient who has been scheduled for a provider visit in the Urology clinic for a diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) who fulfills eligibility criteria will be considered for participation in this study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Auricular Acupressure (AA) Group

Participants will receive the AA intervention over a 5 day period in addition to their Standard of Care treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), and complete daily study questionnaires

Group Type EXPERIMENTAL

Auricular Acupressure

Intervention Type DEVICE

Auricular Acupressure (AA) utilizing all-natural vaccaria ear seeds will be applied to 5 designated sites on each participant's ear (total of 10 seeds placed per patient).

Participants will be asked if they consent to having their ear placement photographed after placement (optional) and audio recorded during interventionist ear seed placement (optional) in collaboration with the BAApress training fidelity study.

Interventions

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Auricular Acupressure

Auricular Acupressure (AA) utilizing all-natural vaccaria ear seeds will be applied to 5 designated sites on each participant's ear (total of 10 seeds placed per patient).

Participants will be asked if they consent to having their ear placement photographed after placement (optional) and audio recorded during interventionist ear seed placement (optional) in collaboration with the BAApress training fidelity study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18 years
* History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)
* Able to read and understand informed consent form in English

Exclusion Criteria

* Patients with a history of skin disease (e.g. psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on the ear
* Cognitive impairment (e.g. delirium, dementia)
* Physical impairment preventing them from applying daily pressure/stimulation to ear seeds
* Patients with cardiac pacemakers (contraindication to POINTER PAL)
* Use of some types of hearing aids (which could potentially obstruct placements of ear seeds)
* Any acute illness or psychiatric conditions that would impact adherence to the study requirements
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Walker, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

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IRB00090489

Identifier Type: -

Identifier Source: org_study_id

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