arpa-h smart band-aid to measure chronic pain in women

Conditions: Chronic Pain

Summary: 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).

Eligibility criteria:
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

Keywords: smart band-aid a-band chronic pain arpa-h ai and chronic pain objective measure biomarker