Clinical trial NCT05857020: Auricular Acupressure Therapy for Patients With IC/BPS
Official title: Battlefield Auricular Acupressure (BAApress) for Chronic Pain Management in Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Urologic Diseases
Chronic Pain
Keywords: interstitial cystitis
bladder pain syndrome
pelvic pain
urologic pain
urologic disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores using Numeric Rating Scale (NRS)
timeFrame: Baseline
measure: Pain scores using Numeric Rating Scale (NRS)
timeFrame: Day 1
measure: Pain scores using Numeric Rating Scale (NRS)
timeFrame: Day 2
measure: Pain scores using Numeric Rating Scale (NRS)
timeFrame: Day 3
measure: Pain scores using Numeric Rating Scale (NRS)
timeFrame: Day 4
measure: Pain scores using Numeric Rating Scale (NRS)
timeFrame: Day 5
measure: Change in Pain, Enjoyment, and General Activity (PEG) Assessment Scores
timeFrame: Day 5
Secondary outcomes:
measure: Change in amount of Opioid Use
timeFrame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5
measure: Pain Catastrophizing Scale (PCS) Assessments
timeFrame: Baseline and Day 5
measure: Auricular Acupressure Acceptability - Likert scale scores
timeFrame: Day 5
measure: Auricular Acupressure Acceptability - auricular acupressure
timeFrame: Day 5
measure: Auricular Acupressure Acceptability - Feedback
timeFrame: Day 5
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: Day 5
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
timeFrame: Baseline and Day 5
measure: Change in IC/BPS symptoms as measured by the Interstitial Cystitis Symptom Index (ICSI)
timeFrame: Baseline and Day 5
measure: Change in IC/BPS symptoms as measured by the Interstitial Problem Index (ICPI)
timeFrame: Baseline and Day 5
measure: Change in IC/BPS symptoms as measured by the Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale
timeFrame: Baseline and Day 5
measure: Change in pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
timeFrame: Baseline and Day 5
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: