ARPA-H Smart Band-Aid to Measure Chronic Pain in Women
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNorthwestern University
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
This trial accepts healthy volunteersQualifiers
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 population
Biological females with chronic pain and biological females without chronic pain
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
A-Band (Smart Band-Aid)
DeviceThe 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
Combination productA 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
BehavioralHADS- 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)
Treatment groups
115 Participants
are divided into 2 treatment groupsGroup A: Chronic pain patients3 interventions
Group B: Healthy control patients3 interventions
Trial outcomes
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).
Time frame
Days 0 thru 7, for 8 total daysSecondary outcomes
1
Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components)
Biomarker readings from interstitial fluid, blood serum, and a commercial smart band will be inserted into an AI machine learning algorithm and combined with the scores on the instruments measuring the affective and cognitive pain components to develop an "objective" pain score. The affective-motivational component will be determined by scores on the Hospital Anxiety \& Depression Scale, Somatic Symptom Scale-8 \& Athens Insomnia Scale. The cognitive-evaluative component will be determined by scores on the Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire-10 and Somatic Symptom Scale-8.
Time frame
From Day 0 thru Day 7, for 8 total days2
Patient-reported pain score
Patient-reported pain scale on a 0-10 pain scale (Defense and Veterans Pain Rating Scale), recorded at least twice per day upon patch application.
Time frame
Days 0 thru 7, for 8 total daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
Tufts University
Collaborator
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
Source ClinicalTrials.gov