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

NCT06994988 | Not Yet Recruiting FDA Device

• 2 other identifiers: STU00223452FP00008853
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Difference between patient-reported pain score and objective pain score as calculated by AI

  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).

  Days 0 thru 7, for 8 total days

Secondary Outcomes (2)

• 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

• Patient-reported pain score

  Days 0 thru 7, for 8 total days

Study Arms (2)

Chronic pain patients

85 female patients with chronic pain \> 3 months duration

Device: A-Band (Smart Band-Aid); Combination Product: Empatica Smartwatch; Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale

Healthy control patients

35 healthy control patients

Device: A-Band (Smart Band-Aid); Combination Product: Empatica Smartwatch; Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale

Interventions

A-Band (Smart Band-Aid) DEVICE

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.

Chronic pain patients; Healthy control patients

Empatica Smartwatch COMBINATION_PRODUCT

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.

Chronic pain patients; Healthy control patients

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

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)

Chronic pain patients; Healthy control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Biological females with chronic pain and biological females without chronic pain

You may qualify if:

• 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.

You may not qualify if:

• Ability to provide informed consent.
• 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

Sponsors & Collaborators

• Northwestern University: lead
• Tufts University: collaborator
• The Advanced Research Projects Agency for Health (ARPA-H): collaborator
• Walter Reed National Military Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (2)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Related Publications (8)

• Guo LL, Pfohl SR, Fries J, Johnson AEW, Posada J, Aftandilian C, Shah N, Sung L. Evaluation of domain generalization and adaptation on improving model robustness to temporal dataset shift in clinical medicine. Sci Rep. 2022 Feb 17;12(1):2726. doi: 10.1038/s41598-022-06484-1.

  PMID: 35177653 BACKGROUND

• Wu Z, Yao H, Liebovitz D, Sun J. An iterative self-learning framework for medical domain generalization. Advances in Neural Information Processing Systems. 2024 Feb 13;36.

  BACKGROUND

• Strawbridge R, Young AH, Cleare AJ. Biomarkers for depression: recent insights, current challenges and future prospects. Neuropsychiatr Dis Treat. 2017 May 10;13:1245-1262. doi: 10.2147/NDT.S114542. eCollection 2017.

  PMID: 28546750 BACKGROUND

• Yang J, Luo R, Yang L, Wang X, Huang Y. Microneedle-Integrated Sensors for Extraction of Skin Interstitial Fluid and Metabolic Analysis. Int J Mol Sci. 2023 Jun 8;24(12):9882. doi: 10.3390/ijms24129882.

  PMID: 37373027 BACKGROUND

• Diaz MM, Caylor J, Strigo I, Lerman I, Henry B, Lopez E, Wallace MS, Ellis RJ, Simmons AN, Keltner JR. Toward Composite Pain Biomarkers of Neuropathic Pain-Focus on Peripheral Neuropathic Pain. Front Pain Res (Lausanne). 2022 May 11;3:869215. doi: 10.3389/fpain.2022.869215. eCollection 2022.

  PMID: 35634449 BACKGROUND

• Telli H, Ozdemir C. Is nociplastic pain, a new pain category, associated with biochemical, hematological, and inflammatory parameters? Curr Med Res Opin. 2024 Mar;40(3):469-481. doi: 10.1080/03007995.2024.2304106. Epub 2024 Jan 22.

  PMID: 38204412 BACKGROUND

• Eldabe S, Obara I, Panwar C, Caraway D. Biomarkers for Chronic Pain: Significance and Summary of Recent Advances. Pain Res Manag. 2022 Nov 7;2022:1940906. doi: 10.1155/2022/1940906. eCollection 2022.

  PMID: 36385904 BACKGROUND

• Tracey I, Woolf CJ, Andrews NA. Composite Pain Biomarker Signatures for Objective Assessment and Effective Treatment. Neuron. 2019 Mar 6;101(5):783-800. doi: 10.1016/j.neuron.2019.02.019.

  PMID: 30844399 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, saliva

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jordan Wood, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edmond I Eger Professor of Anesthesiology and Vice Chair of Pain Medicine

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 23, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: For 3 years after completion of the study
• Access Criteria: Investigators with an IRB-approved protocol, after approval from sponsor.

Locations

US (2)