Overview
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
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).
Eligibility
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
