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

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