About this trial
This pilot study aims to investigate the viability of using a smartwatch-based electrodermal activity (EDA) sensor to capture enough EDA signal to quantitatively assess pain in osteoarthritis subjects and test the feasibility of its methods and procedures for later use in subsequent larger-scale studies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Kellgren-Lawrence Grade >= 3
Disqualifiers
Inflammatory arthropathy (e.g., rheumatoid arthritis), BMI >=35
Complaints of lower extremity joint pain
Known diagnosis of knee osteoarthpathy
Prior history of knee surgery, knee injections, or injury to knee joints (e.g., meniscus tears, ligamentous injuries), BMI >=35
Trial design
Single group
Treatments tested in this trial
Electrodermal Activity signal
DeviceDetermining if the electrodermal activity signals, as measured by the Embrace Plus smartwatch) can be used to measure osteoarthritic patient pain levels.
Treatment groups
Trial outcomes
Primary outcomes
:Difference in pain measurements as reported by the participant via a visual analogue scale versus smartwatch reported electrodermal activity sensors
As a pilot study, the goal is not hypothesis testing but rather examining the feasibility of this approach to measuring patient pain in osteoarthritic patients. Thus, the statistical analysis will be primarily descriptive. The baseline experiment is being done to see whether the smartwatch measurements are at all comparable to prior similar experiments using the thermal grill (Posada-Quintero 2016; Posada-Quintero 2021). For this reason, though not typical for a pilot study, participant responses to the baseline test will use similar analysis to prior electrodermal activity (EDA) based thermal grill studies to see if the smartwatch poses a viable EDA signal collection source. This primarily consists of repeated measures analysis of variance (ANOVA) comparing patient-reported visual analog scale (VAS) scores to EDA output.
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) 30-second chair test
Patients will be asked to participate in the standardized OARSI 30-second chair test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) 30-second chair test
A smartwatch will capture the patient's EDA signals during the 30-second chair test
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) 40m fast-paced walk test
Patients will be asked to participate in the standardized OARSI 40m fast-paced walk test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Sponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
University of Connecticut
Collaborator
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