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

Multi-modal Smart Band-Aid for AI-based Quantification of Pain

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

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

About the study

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

What is being tested

• A-Band (Smart Band-Aid) (device)
• Empatica Smartwatch (combination product)
• Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale (behavioral)

Sponsor: Northwestern University · Participants: 115 · Started: Jul 6, 2026

Contact the study team

• Jordan Wood, BS · Phone: 312-695-0915

Official record on ClinicalTrials.gov — NCT06994988

Locations in the U.S.

Conditions

• Chronic Pain

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.