An observational study in Chronic Pain, sponsored by Northwestern University. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Northwestern University · Observational
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:
Researchers will compare data from these tools with self-reported pain scores in women with chronic pain and healthy women.
Participants will:
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).
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 115 is close to the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Biological females with chronic pain and biological females without chronic pain
For chronic pain group:
For healthy controls:
Exclusion Criteria (both groups):
Pregnant or breastfeeding women.
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
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
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.
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.
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)
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 days
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 days
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 days
Plan to share: Yes — IPD will be shared upon request with IRB approval.
Supporting information: Study protocol, Sap, Icf, Analytic code
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