ARPA-H Smart Band-Aid to Measure Chronic Pain in Women

Multi-modal Smart Band-Aid for AI-based Quantification of Pain

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

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).

Inclusion Criteria:

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 exclusion criteria.
• 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