Multi-modal Smart Band-Aid for AI-based Quantification of Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- Difference between patient-reported pain score and objective pain score as calculated by AI
研究概览
简要总结
The goal of this clinical trial is to test whether a minimally invasive microneedle patch, called the A-Band (Smart Band-aid), worn on the arm (monitoring key biomarkers in interstitial fluid) and a commercial smartwatch can accurately correlate with self-reported pain in women with chronic pain. A secondary purpose of the study is to identify demographic and clinical variables impacting pain measurement.
The main questions that this study aims to answer are:
- What is the correlation between AI-adjusted pain scores, based on biomarkers and validated tools, and self-reported pain scores?
- What influence do demographic and clinical information have in the correlation of these pain scores?
Researchers will compare data from these tools with self-reported pain scores in women with chronic pain and healthy women.
Participants will:
- Be a part of the study for approximately 8 days
- Attend 2-3 in-person visits at the applicable clinical center over approximately one week
- Wear a Smart Band-Aid (A-Band) at least twice per day for a week, with each application lasting up to 90 minutes
- Complete questionnaires regarding medical history, pain information, mental health, sleep, and demographic data
- Record daily pain scores
- Wear a smartwatch for one week which will collect biophysical data (heart rate, skin response, etc.)
- Collect daily saliva samples
- Have blood drawn by medical staff at 2 in-person visits
详细描述
This study proposes the collection of interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.
The A-Band is an investigational device and has not been approved for use by the Food and Drug Administration (FDA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For chronic pain group:
- •Female, 18 years or older.
- •Diagnosis of chronic pain condition (e.g., fibromyalgia, chronic lower back pain) as determined by the Principal Investigator.
- •Ability to provide informed consent.
- •For healthy controls:
- •Female, 18 years or older.
- •No history of chronic pain.
- •No significant or poorly controlled medical conditions as determined by the Principal Investigator and
排除标准
- •No significant active, poorly controlled psychological conditions as determined by the Principal Investigator and exclusion criteria.
- •Ability to provide informed consent.
- •Exclusion Criteria (both groups):
- •Pregnant or breastfeeding women.
- •Substance abuse or psychiatric disorders that interfere with study participation.
- •Major medical conditions (such as severe cardiovascular, neurological, cancer or autoimmune diseases) or psychological conditions (e.g., active, poorly-controlled depression, anxiety disorder, PTSD, substance use disorder) that interfere with study participation.
- •Possibility of secondary financial gain from participation
- •Interventional pain treatment(s) within 6 weeks of baseline (injection, epidural, etc.)
- •Current opioid usage or usage within 2 weeks of baseline
研究组 & 干预措施
Healthy control patients
35 healthy control patients
干预措施: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale (Behavioral)
Chronic pain patients
85 female patients with chronic pain > 3 months duration
干预措施: Empatica Smartwatch (Combination Product)
Chronic pain patients
85 female patients with chronic pain > 3 months duration
干预措施: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale (Behavioral)
Healthy control patients
35 healthy control patients
干预措施: A-Band (Smart Band-Aid) (Device)
Healthy control patients
35 healthy control patients
干预措施: Empatica Smartwatch (Combination Product)
Chronic pain patients
85 female patients with chronic pain > 3 months duration
干预措施: A-Band (Smart Band-Aid) (Device)
结局指标
主要结局
Difference between patient-reported pain score and objective pain score as calculated by AI
时间窗: Days 0 thru 7, for 8 total days
We will measure the difference between the patient-reported pain scores and AI-generated objective pain score in subgroups of chronic pain patients (e.g., nociplastic pain, neuropathic pain, nociceptive pain, mixed pain) and healthy controls (if they have acute pain).
次要结局
- Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components)(From Day 0 thru Day 7, for 8 total days)
- Patient-reported pain score(Days 0 thru 7, for 8 total days)
研究者
Steven Cohen
Edmond I Eger Professor of Anesthesiology and Vice Chair of Pain Medicine
Northwestern University