Auricular Acupressure Therapy for Patients With IC/BPS

NCT05857020 | Withdrawn FDA Device

• 1 other identifier: IRB00090489
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome; Urologic Diseases; Chronic Pain

Keywords

interstitial cystitis; bladder pain syndrome; pelvic pain; urologic pain; urologic disease

Outcome Measures

Primary Outcomes (7)

• Pain scores using Numeric Rating Scale (NRS)

  The NRS pain score is an 11-point pain scale in which patients will be asked to circle a number between 0 and 10 that best represents their current pain intensity. 0 usually indicates "no pain at all" and 10 indicates "worst pain imaginable."

  Baseline

• Pain scores using Numeric Rating Scale (NRS)

  The NRS pain score is an 11-point pain scale in which patients will be asked to circle a number between 0 and 10 that best represents their current pain intensity. 0 usually indicates "no pain at all" and 10 indicates "worst pain imaginable."

  Day 1

• Pain scores using Numeric Rating Scale (NRS)

  The NRS pain score is an 11-point pain scale in which patients will be asked to circle a number between 0 and 10 that best represents their current pain intensity. 0 usually indicates "no pain at all" and 10 indicates "worst pain imaginable."

  Day 2

• Pain scores using Numeric Rating Scale (NRS)

  The NRS pain score is an 11-point pain scale in which patients will be asked to circle a number between 0 and 10 that best represents their current pain intensity. 0 usually indicates "no pain at all" and 10 indicates "worst pain imaginable."

  Day 3

• Pain scores using Numeric Rating Scale (NRS)

  The NRS pain score is an 11-point pain scale in which patients will be asked to circle a number between 0 and 10 that best represents their current pain intensity. 0 usually indicates "no pain at all" and 10 indicates "worst pain imaginable."

  Day 4

• Pain scores using Numeric Rating Scale (NRS)

  The NRS pain score is an 11-point pain scale in which patients will be asked to circle a number between 0 and 10 that best represents their current pain intensity. 0 usually indicates "no pain at all" and 10 indicates "worst pain imaginable."

  Day 5

• Change in Pain, Enjoyment, and General Activity (PEG) Assessment Scores

  The PEG assesses a patient's reported intensity of pain and interference with general activity. It involves three 11-point numeric rating scales (NRS) ranging from 0 ("no pain" or "does not interfere") to 10 ("pain as bad as you can imagine" or "completely interferes"). Scores from each NRS will be compared before and after use of the study intervention. Higher scores represent more pain and or increased enjoyment and activity interference.

  Day 5

Secondary Outcomes (11)

• Change in amount of Opioid Use

  Baseline, Day 1, Day 2, Day 3, Day 4, Day 5

• Pain Catastrophizing Scale (PCS) Assessments

  Baseline and Day 5

• Auricular Acupressure Acceptability - Likert scale scores

  Day 5

• Auricular Acupressure Acceptability - auricular acupressure

  Day 5

• Auricular Acupressure Acceptability - Feedback

  Day 5

Study Arms (1)

Auricular Acupressure (AA) Group

EXPERIMENTAL

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

Device: Auricular Acupressure

Interventions

Auricular Acupressure 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.

Auricular Acupressure (AA) Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Cystitis, Interstitial; Urologic Diseases; Chronic Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Walker, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 12, 2023
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share