Chronic Pain Clinical Trials

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Multi-modal Smart Band-Aid for AI-based Quantification of Pain

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral, Combination product
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Illinois
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Maryland
Walter Reed National Military Medical Center
NOT_YET_RECRUITING
Bethesda
Contact Information
Primary
Jordan Wood, BS
jordan.wood1@northwestern.edu
312-695-0915
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-04-23
Participants
Target number of participants: 115
Treatments
Chronic pain patients
85 female patients with chronic pain \> 3 months duration
Healthy control patients
35 healthy control patients
Related Therapeutic Areas
Sponsors
Collaborators: The Advanced Research Projects Agency for Health (ARPA-H), Tufts University, Henry M. Jackson Foundation for the Advancement of Military Medicine, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center
Leads: Northwestern University

This content was sourced from clinicaltrials.gov