Not Yet RecruitingNot Applicable

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

United States115 participantsStarted 2026-05-01

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Difference between patient-reported pain score and objective pain score as calculated by AI

Timeframe: Days 0 thru 7, for 8 total days

Trial details

NCT IDNCT06994988

SponsorNorthwestern University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-23

Contact for this trial

Jordan Wood, BS

312-695-0915 jordan.wood1@northwestern.edu