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

Not yet recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06994988
• Lead Sponsor: Northwestern University

Brief 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

Detailed Description

This study proposes the collection of interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.

The A-Band is an investigational device and has not been approved for use by the Food and Drug Administration (FDA).

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-07-01
• Primary Completion: 2026-10-23
• Study Completion: 2026-10-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 115

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between patient-reported pain score and objective pain score as calculated by AI	Days 0 thru 7, for 8 total days	We will measure the difference between the patient-reported pain scores and AI-generated objective pain score in subgroups of chronic pain patients (e.g., nociplastic pain, neuropathic pain, nociceptive pain, mixed pain) and healthy controls (if they have acute pain).

Secondary Outcome Measures

Name	Time	Method
Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components)	From Day 0 thru Day 7, for 8 total days	Biomarker readings from interstitial fluid, blood serum, and a commercial smart band will be inserted into an AI machine learning algorithm and combined with the scores on the instruments measuring the affective and cognitive pain components to develop an "objective" pain score. The affective-motivational component will be determined by scores on the Hospital Anxiety \& Depression Scale, Somatic Symptom Scale-8 \& Athens Insomnia Scale. The cognitive-evaluative component will be determined by scores on the Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire-10 and Somatic Symptom Scale-8.
Patient-reported pain score	Days 0 thru 7, for 8 total days	Patient-reported pain scale on a 0-10 pain scale (Defense and Veterans Pain Rating Scale), recorded at least twice per day upon patch application.

Trial Locations

Locations (2)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States