nCap Pain Relief Patch vs. Placebo

nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial

The purpose of this study is to determine whether use of the nCap Medical Nano-Capacitive pain relief patch reduces subject pain as measured by subject pain scores, WOMAC scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.

Inclusion Criteria:

• Meet Altman's clinical criteria for Knee Osteoarthritis
• Male and Female Adults age 40-79
• VAS pain score of > 4 at the beginning of the study

Exclusion Criteria:

• Subject unable to walk unassisted. Participants must be able to stand/walk for 30 minutes
• Inability to read and understand English. Must be able to complete WOMAC scale and questionnaires
• Severe systemic disease limiting ability to ambulate for 30 minutes
• Use of a TENS unit for one week before study or during study
• History of total knee replacement on the affected knee
• Knee surgery on the affected knee in the last 12 months
• Injection into the knee in the last 6 months
• Knee pain < 411
• Inability to cognitively understand consent form or research study, or inability to give consent
• Diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases.
• Malignancy
• Injury to knee within 6 months
• Concomitant use of opioids, NSAIDS or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen.
• Pregnant or lactating
• Poor general health (ASA classification of IV+)