Electrodermal Activity Signals for Osteoarthritis

Overseen By Jon M Coordinator, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: NSAIDs, Acetaminophen, Steroids, others

Disqualifiers: Heart problems, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartwatch can effectively measure pain in people with osteoarthritis by tracking electrodermal activity (EDA), a skin response that changes with pain. The goal is to determine if this method could be used in future, larger studies. Individuals with significant knee osteoarthritis and no inflammatory arthritis might be suitable candidates, but those with severe heart problems or who use certain medications, such as pain relievers, should not participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new pain management solutions.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, such as NSAIDs, acetaminophen, steroidal anti-inflammatory agents, bronchodilators, appetite suppressants, and lipase inhibitors, within 12 hours of the experiment and during the experiment, unless they are medications you normally take daily.

What prior data suggests that this method is safe for osteoarthritis patients?

Research has shown that specific safety information for using Electrodermal Activity (EDA) signals in people is not available. EDA measures changes in the skin's electrical conductivity, often using devices like smartwatches. This method is generally considered non-invasive and safe. However, due to the lack of detailed safety data, some risks might not be fully known. This study is in an early research phase, focusing more on testing the method's effectiveness rather than on detailed safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring electrodermal activity (EDA) signals for osteoarthritis because this approach could provide a new way to understand and manage pain associated with the condition. Unlike standard treatments such as NSAIDs or physical therapy, which focus on reducing symptoms, EDA measurement aims to objectively assess the body's electrical responses to pain. This could lead to more personalized and precise management strategies by identifying how different individuals react to pain. By focusing on the body's natural electrical signals, this method offers a non-invasive and potentially more accurate means of monitoring and addressing osteoarthritis pain.

What evidence suggests that this method is effective for assessing pain in osteoarthritis?

Research shows that pain levels can be measured by tracking changes in how the skin conducts electricity, known as electrodermal activity (EDA). A wearable device, such as a smartwatch, performs this measurement. An increase in skin conductance often indicates higher pain or stress levels. This method is non-invasive, meaning it doesn't involve breaking the skin or entering the body, making it easy to use. Early studies have shown that EDA reliably captures real-time pain data in conditions like osteoarthritis. In this trial, participants will have their baseline EDA response to pain measured, as well as their EDA response during a set of standardized functional tests. These findings suggest that EDA could be a promising tool for assessing pain in osteoarthritis patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter L Schilling, MD, MS

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with osteoarthritis. The study aims to include participants who can provide reliable data through a smartwatch-based sensor.

Inclusion Criteria

My knee arthritis is severe.

Exclusion Criteria

Subjects with Raynaud's syndrome

Participants who have a skin sensitivity to metals, have a pacemaker or defibrillator, or have recent head trauma within the past two weeks (even without loss of consciousness)

Participants who cannot feel physical pain or have a history of self-harm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Participants' baseline electrodermal activity (EDA) response to pain is measured using a thermal grill and visual analogue scale (VAS).

1 day

1 visit (in-person)

Functional Testing

Participants undergo OARSI standardized functional tests (30-second chair test, 40m fast-paced walk, stair climb test) while EDA signals are recorded.

1 day

1 visit (in-person)

Data Analysis

Analysis of EDA signals to assess the accuracy and sensitivity of pain detection.

Concurrent with data collection

Follow-up

Participants are monitored for any adverse effects and the effectiveness of the EDA measurement method.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrodermal Activity signal

Trial Overview The trial is testing the use of a smartwatch-based electrodermal activity (EDA) sensor to measure pain levels in people with osteoarthritis, as part of a pilot study before larger-scale research.

How Is the Trial Designed?

Group I: Electrodermal Activity Measurement Subjects Experimental Treatment 1 Intervention

Participants will have their baseline electrodermal activity (EDA) response to pain measured as well as their EDA response measured while participating in a set of standardized functional tests.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06701461

Measurement of Osteoarthritic Patient Pain Through ... This pilot study aims to investigate the viability of using a smartwatch-based electrodermal activity (EDA) sensor to capture enough EDA signal to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809522/

Utilising electrodermal activity sensor signals to quantify ... Changes in electrodermal activity (EDA) can be detected via changes in skin conductance (SC) and measured using finger electrodes on a wearable sensor.

3. withpower.com withpower.com/trial/phase-osteoarthritis-knee-10-2024-41f14

Electrodermal Activity Signals for Osteoarthritis What data supports the effectiveness of the treatment Electrodermal Activity signal for osteoarthritis? A study on a non-invasive electrodermal biofeedback ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169260723005254

Simulation of ambulatory electrodermal activity and the ... This study presented a simulation technique for generating 200 h of high-quality EDA data and contaminating this EDA with 0.125 to 3 artifacts per minute.

5. researchgate.net researchgate.net/publication/377662288_Utilising_electrodermal_activity_sensor_signals_to_quantify_nociceptive_response_during_movement_activities

(PDF) Utilising electrodermal activity sensor signals to ... Changes in electrodermal activity (EDA) can be detected via changes in skin conductance (SC) and measured using finger electrodes on a wearable ...

6. mdpi.com mdpi.com/1424-8220/25/12/3603

Feasibility Study of Using Alternating Current Excitation to ... This study investigates the feasibility of using a wearable system with full-wave alternating current (AC) excitation to measure electrodermal activity (EDA).

7. trials.arthritis.org trials.arthritis.org/?_ga=2.30625727.1041505448.1550700145-1568121850.1546633598&page=83&utm_campaign=Clinical-Trial-Finder&utm_medium=post&utm_source=blog

Filters - Clinical Trial Finder - Arthritis Foundation This pilot study aims to investigate the viability of using a smartwatch-based electrodermal activity (EDA) sensor to capture enough EDA signal to ...