Battlefield Auricular Acupressure (BAApress) for Chronic Pain Management in Patients With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Pain, Enjoyment, and General Activity (PEG) Assessment Scores
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)
- •Able to read and understand informed consent form in English
排除标准
- •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
结局指标
主要结局
Change in Pain, Enjoyment, and General Activity (PEG) Assessment Scores
时间窗: 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.
Pain scores using Numeric Rating Scale (NRS)
时间窗: 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."
次要结局
- Change in IC/BPS symptoms as measured by the Interstitial Cystitis Symptom Index (ICSI)(Baseline and Day 5)
- Change in IC/BPS symptoms as measured by the Interstitial Problem Index (ICPI)(Baseline and Day 5)
- 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)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form(Baseline and Day 5)
- Change in IC/BPS symptoms as measured by the Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale(Baseline and Day 5)
- Change in Patient Global Impression of Change (PGIC)(Day 5)
- Change in pelvic pain, as measured by the Brief Pain Inventory (BPI) Short Form(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)