Measurement of Osteoarthritic Patient Pain Through Electrodermal Activity Signals

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to measure pain in people with knee osteoarthritis by using a smartwatch that tracks electrical signals from the skin, known as electrodermal activity (EDA). The goal is to see if this method can effectively capture pain levels and help researchers understand how to use it in future, larger studies. The trial is not recruiting participants yet, but when it does, it will focus on adults aged 18 to 65 who have a specific severity of knee osteoarthritis.

To be part of the study, participants must have a high grade of knee osteoarthritis and cannot have certain other knee problems or serious health issues, such as heart conditions. They also need to avoid certain medications and substances before the study. If eligible, participants will wear a smartwatch during the study, which will help researchers gather important information about their pain. This trial is a first step toward better ways to assess and manage pain for people living with osteoarthritis.

Gender

ALL

Eligibility criteria

• • Study subjects
• Inclusion Criteria:
• • Kellgren-Lawrence Grade \>= 3
• Exclusion Criteria:
• • Inflammatory arthropathy (e.g., rheumatoid arthritis), BMI \>=35
• Control subjects:
• Exclusion Criteria:
• • 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
• Both groups, exclusion:
• • Subjects with chronic heart problems, including, but not limited to, chronic hypertension, heart palpitations, a weak or irregular heartbeat, or a previous heart attack,
• • Subjects taking the following drugs within 12 hours of the experiment or during the experiment: caffeine, alcohol, psychoactive drugs, nicotine or marijuana, other recreational drugs, and medicine of any kind that is not normally taken daily. Such medications include;
• • NSAIDs
• • Acetaminophen
• • Steroidal anti-inflammatory agents
• • Bronchodilators
• • Appetite suppressants
• • Lipase inhibitors
• • Women who are currently pregnant
• • Subjects with Raynaud's syndrome
• • Subjects with any of the following conditions: active skin lesions where EDA sensors are, vertigo or dizziness, and anyone with postural orthostatic tachycardia syndrome (POTS), peripheral neuropathy, seizure disorders, methicillin-resistant staphylococcus aureus (MRSA), impaired circulation, medical implants, open skin lesions, chronic eczema on hands where EDA and electrical stimulator's electrodes are attached, diabetes, and epilepsy.
• • 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