Recruiting

A-Band & Smartwatch

Sponsor:

Northwestern University

Code:

NCT06994988

Conditions

Chronic Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

A-Band (Smart Band-Aid)

Empatica Smartwatch

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

Study Details

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

Conditions

Chronic Pain

Study ID

NCT06994988

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Apr 23, 2027

Anticipated

Primary completion date

Apr 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

115 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic pain patients

85 female patients with chronic pain > 3 months duration

Healthy control patients

35 healthy control patients

Interventions

A-Band (Smart Band-Aid)

The A-Band is a smart band-aid placed on the forearm or other designated site that collects 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.

Empatica Smartwatch

A commercial smart band will be worn by participants for 22+ hours a day for approximately 7 days. The smart band collects biophysical data from the participant. This includes data on biomarkers, heart rate and heart rate variability, galvanic skin response, step count, and temperature fluctuations, among other biophysical data.

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

HADS- measures anxiety and depression (0-21, higher scores signify greater pathology); CSI- measures central sensitization (0-100, higher scores signify greater central sensitization, PCS- measures catastrophizing (0-52, higher scores signify greater catastrophization), SSS-8- measures somatization (0-32, higher scores signify greater somatization), PSEQ-10- measures self-efficacy (0-60, with lower scores signifying low self-efficacy), AIS- measures sleep (0-28, with higher scores signifying greater sleep dysfunction)

Primary outcome measure

  • Difference between patient-reported pain score and objective pain score as calculated by AI [ Time Frame: Days 0 thru 7, for 8 total days ]

Central Contacts and Locations

Central contacts

Jordan Wood, BS

312-695-0915jordan.wood1@northwestern.edu

Locations

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jordan Wood, BS

312-695-0915jordan.wood1@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Smart Band-Aid
  • A-Band
  • Chronic Pain
  • ARPA-H
  • AI and Chronic Pain
  • Objective measure
  • Biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.