nCap Pain Relief Patch vs. Placebo

nCap Medical

Status

Unknown

Conditions

Osteoarthritis, Knee

Treatments

Device: nCap pain relief patch

Device: Sham Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT04753567

00127554

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

40 to 79 years old

Volunteers

Accepts Healthy Volunteers

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+)