Measurement of Osteoarthritic Patient Pain Through Electrodermal Activity Signals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorDartmouth-Hitchcock Medical Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Electrodermal Activity signal

    Device

    Determining if the electrodermal activity signals, as measured by the Embrace Plus smartwatch) can be used to measure osteoarthritic patient pain levels.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Electrodermal Activity Measurement SubjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

: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.

Time frame
40 minutes of test time, occurring all in one day.
2

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.

Time frame
5 minutes
3

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

Time frame
0 minutes. Concurrent with measurement of patient-reported pain.
4

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.

Time frame
10 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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Dartmouth-Hitchcock Medical Center

Lead sponsor

University of Connecticut

Collaborator

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