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

Northwestern University

Status

Not yet enrolling

Conditions

Chronic Pain

Treatments

Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale

Combination Product: Empatica Smartwatch

Device: A-Band (Smart Band-Aid)

Study type

Observational

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT06994988

FP00008853 (Other Grant/Funding Number)

STU00223452

Details and patient eligibility

About

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

Full 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).

Enrollment

115 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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