RecruitingNot Applicable

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

United States115 participantsStarted 2026-07-01

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 range

18 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Chronic Pain trials