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

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Electrodermal Activity signal for osteoarthritis?

A study on a non-invasive electrodermal biofeedback device showed it could help reduce chronic pain and inflammation, suggesting that electrodermal activity signals might be useful in managing osteoarthritis pain. ^{1 2 3 4 5}

Is Electrodermal Activity (EDA) safe for use in humans?

The research does not provide specific safety data for Electrodermal Activity (EDA) in humans, but it is a noninvasive method often used to study emotions, decision making, and health, suggesting it is generally considered safe. ^{2 6 7 8 9}

How does the Electrodermal Activity signal treatment for osteoarthritis differ from other treatments?

The Electrodermal Activity (EDA) signal treatment is unique because it uses a non-invasive method to measure the activity of the sympathetic nervous system, which can help monitor chronic pain conditions like osteoarthritis. Unlike traditional treatments that may involve medication or physical therapy, EDA focuses on capturing physiological signals through wearable devices, offering a novel approach to understanding and managing pain. ^{2 3 6 10 11}

What is the purpose of 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.

Research Team

Peter L Schilling, MD, MS

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

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

I have a condition like rheumatoid arthritis and my BMI is 35 or higher.

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)

I am currently pregnant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

The association between knee temperature and pain in elders with osteoarthritis of the knee: a pilot study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A Deep Convolutional Autoencoder for Automatic Motion Artifact Removal in Electrodermal Activity. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Model-Based Framework for Assessing the Physiologic Structure of Electrodermal Activity. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical validation of a non-invasive electrodermal biofeedback device useful for reducing chronic perceived pain and systemic inflammation. [2020]

5. Poland pubmed.ncbi.nlm.nih.gov

Cutaneous temperature and pressure pain threshold in individuals with knee osteoarthritis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Validation of a Multimodal Wearable Device for Simultaneous Collection of Electrocardiogram, Electromyogram, and Electrodermal Activity. [2023]

7. England pubmed.ncbi.nlm.nih.gov

An unsupervised automated paradigm for artifact removal from electrodermal activity in an uncontrolled clinical setting. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Respiration-related artifacts in EDA recordings: introducing a standardized method to overcome multiple interpretations. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Simple, Transparent, and Flexible Automated Quality Assessment Procedures for Ambulatory Electrodermal Activity Data. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Validation of Spectral Indices of Electrodermal Activity with a Wearable Device. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Validity of electrodermal activity-based measures of sympathetic nervous system activity from a wrist-worn device. [2021]