Interstitial CystitisIC/BPSNCT05857020
Auricular Acupressure Therapy for Patients With IC/BPS
A study testing Auricular Acupressure in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome, Urologic Diseases
- What is being tested?
- Auricular Acupressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)
- Able to read and understand informed consent form in English
Who cannot join
- 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
About this study
Official title: Battlefield Auricular Acupressure (BAApress) for Chronic Pain Management in Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
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.
Read the 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).
- Being tested
- Auricular Acupressure
- Keywords
- interstitial cystitis, bladder pain syndrome, pelvic pain, urologic pain, urologic disease
- Medical subject headings
- Cystitis, Interstitial, Urologic Diseases, Chronic Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Auricular Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: Day 5
Secondary outcomes (11)
Change in amount of Opioid Use
Participants will be required to document all medications used prior to initiating therapy, and document all medications used while using the auricular acupressure seeds. Information collected will include medication type, frequency of use, and amount (milligrams) used. Mean/median changes from baseline to Day 5 will be calculated.
Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5
Pain Catastrophizing Scale (PCS) Assessments
The PCS assesses the extend of catastrophic thinking due to pelvic/bladder pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale with a total score range from 0 to 52. Each individual question is aimed to assess the thoughts and feelings of the patient using questions that are rated from 0 (not at all) to 4 (all the time). Higher scores are associated with higher amounts of pain catastrophizing.
Measured: Baseline and Day 5
Auricular Acupressure Acceptability - Likert scale scores
Participants will be asked 3 different questions to evaluate overall acceptance of the intervention (auricular acupressure). Responses will be analyzed quantitatively and qualitatively.
- The Likert scale question will be phrased as, "How satisfied were you with how your pain has been treated?" with the scale responses ranging from "5 = Very satisfied, 4 = Satisfied, 3 = Somewhat satisfied, 2 = Somewhat dissatisfied, 1 = Dissatisfied, 0 = Very dissatisfied."
Measured: Day 5
Auricular Acupressure Acceptability - auricular acupressure
Participants will be asked 3 different questions to evaluate overall acceptance of the intervention (auricular acupressure). Responses will be analyzed quantitatively and qualitatively.
- The Yes/No question will be phrased as, "Would you consider using auricular acupressure in the future for pain or if recommended by your nurse of physician?" with responses ranging from "No, I would not use again" (score = 0), "Maybe" (score = 1), and "Yes, I would consider using it in the future" (Score = 2).
Measured: Day 5
Auricular Acupressure Acceptability - Feedback
Participants will be asked 3 different questions to evaluate overall acceptance of the intervention (auricular acupressure). Responses will be analyzed quantitatively and qualitatively.
- The open-ended question will ask, "Is there anything else you would like to tell us that may be helpful for us to know regarding ear acupressure?" Each answer will be collected and assessed for future studies.
Measured: Day 5
Change in Patient Global Impression of Change (PGIC)
The PGIC is a patient-reported assessment of improvement or decline in regard to their pain using a 7-point scale. Responses range from (1) "no change (or condition has got worse)" to (7) "a great deal better, and a considerable improvement that has made all the difference." This questionnaire also includes an 11-point NRS scale asking patient's to circle the number from 0 (much better) to 10 (much worse) that best describes the degree of change experienced since beginning the intervention.
Measured: Day 5
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
This PROMIS sleep disturbance short form aims to assess a patient's reported quality of sleep. Each of the 6 items in the questionnaire is rated on a 5-point scale ranging from 1 (very good) to 5 (very poor).
Measured: Baseline and Day 5
Change in IC/BPS symptoms as measured by the Interstitial Cystitis Symptom Index (ICSI)
The ICSI (score range: 0-19 points) and ICPI (score range: 0-16 points) contain four questions related to urinary and pain symptoms. For the ICSI, 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is almost always experienced.
Measured: Baseline and Day 5
Change in IC/BPS symptoms as measured by the Interstitial Problem Index (ICPI)
For the ICPI, all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating a big problem.
Measured: Baseline and Day 5
Change in IC/BPS symptoms as measured by the Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale
The PUF Patient Symptom Scale is a validated instrument used to assess the severity of symptoms associated with IC/BPS and the degree to which these symptoms "bother" a patient. It is separated into 2 subsections, scored individually as the Symptom Score and Bother score, to produce one composite score. The symptom score is comprised of 7 items addressing urinary frequency, urgency, nocturia, dyspareunia, and pelvic pain. Each item is scored from 0 (never) to 3 (always) or 1 (mild) to 3 (severe), except for two which quantify daytime frequency and nocturia separately with scores ranging from 0 to 4. A composite score between 10 and 14 indicates a strong diagnosis of IC/BPS with higher scores reflecting a greater degree of severity of symptoms and disease progression as well as impact on quality of life.
Measured: Baseline and Day 5
Change in pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
The BPI Short Form is a validated questionnaire to assess the severity of systemic and pelvic pain and its interference in overall quality of life. Pain severity is measured through four 11-point numeric rating scales (NRS) assessing pain at its "worst," "least," and "average," within the past week, and pain "right now" (at the time of short form completion), with the composite (mean score) of all four scales indicating overall pelvic pain. Pain interference is measured through 7 scales, with scores ranging from 0 (does not interfere) to 10 (completely interferes), for different daily activities. The composite score for the interference items is used to assess overall pain interference, with higher scores indicating greater symptom severity and a change in 2 points indicating a significant change in pain. The form also consists of 3 pain body maps to identify specific locations of pain, and 2 questions related to the effect of current medications on pain.
Measured: Baseline and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startJul 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: withdrawn by the sponsor due to personal constraints and limited funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Walker, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857020
- Sponsor's protocol ID
- IRB00090489
- Acronym
- IC/BPS
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battlefield Auricular Acupressure (BAApress) for Chronic Pain Management in Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
- ClinicalTrials.gov ID
- NCT05857020
- Acronym / sponsor ID
- IC/BPS / IRB00090489
- Keywords
- interstitial cystitis, bladder pain syndrome, pelvic pain, urologic pain, urologic disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn by the sponsor due to personal constraints and limited funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure (AA) Group | Experimental | Device: Auricular AcupressureParticipants 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)
- Able to read and understand informed consent form in English
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupressureAuricular 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. | Device | Auricular Acupressure (AA) Group |
Primary outcome
Pain scores using Numeric Rating Scale (NRS)
Time frame: Baseline
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."
Pain scores using Numeric Rating Scale (NRS)
Time frame: Day 1
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."
Pain scores using Numeric Rating Scale (NRS)
Time frame: Day 2
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."
Pain scores using Numeric Rating Scale (NRS)
Time frame: Day 3
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."
Pain scores using Numeric Rating Scale (NRS)
Time frame: Day 4
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."
Pain scores using Numeric Rating Scale (NRS)
Time frame: Day 5
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."
Change in Pain, Enjoyment, and General Activity (PEG) Assessment Scores
Time frame: Day 5
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.
11 secondary outcomes
Change in amount of Opioid Use
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5
Pain Catastrophizing Scale (PCS) Assessments
Time frame: Baseline and Day 5
Auricular Acupressure Acceptability - Likert scale scores
Time frame: Day 5
Auricular Acupressure Acceptability - auricular acupressure
Time frame: Day 5
Auricular Acupressure Acceptability - Feedback
Time frame: Day 5
Change in Patient Global Impression of Change (PGIC)
Time frame: Day 5
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
Time frame: Baseline and Day 5
Change in IC/BPS symptoms as measured by the Interstitial Cystitis Symptom Index (ICSI)
Time frame: Baseline and Day 5
Change in IC/BPS symptoms as measured by the Interstitial Problem Index (ICPI)
Time frame: Baseline and Day 5
Change in IC/BPS symptoms as measured by the Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale
Time frame: Baseline and Day 5
Change in pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form
Time frame: Baseline and Day 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Walker, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores using Numeric Rating Scale (NRS) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.