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

Recruiting now

Conditions studied: Chronic Pain

In brief

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

Key facts

Study ID

NCT06994988

Run by

Northwestern University

People needed

115

Starts

2026-07-01

Expected to finish

2027-04-23

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.