Smart Band-Aid to See If AI-Powered Pain Scores Match How Women Feel Pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use the A-Band microneedle patch to sample interstitial fluid and a smartwatch to collect physiological signals, then compare AI-adjusted pain scores with self-reported pain in women with chronic pain and in healthy controls. The study aims to identify demographic and clinical factors that influence how well the AI-derived scores reflect patient-reported pain. It involves about 8 days of participation, with 2–3 in-person visits at participating centers. The device is investigational and not FDA-approved, and participants will complete several questionnaires to explore related factors like anxiety, sleep, and pain beliefs.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwestern University Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting
• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Not yet recruiting

Study contacts

• Study coordinator: Jordan Wood, BS
• Email: jordan.wood1@northwestern.edu
• Phone: 312-695-0915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.