About this trial
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 criteria
Qualifiers
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.
Female, 18 years or older.
Disqualifiers
No significant active, poorly controlled psychological conditions as determined by the Principal Investigator and exclusion criteria.
Ability to provide informed consent.
Pregnant or breastfeeding women.
Substance abuse or psychiatric disorders that interfere with study participation.
Trial design
Treatments tested in this trial
- 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
Treatment groups
Sponsors and collaborators
Northwestern University
Lead sponsor
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