nCap Pain Relief Patch vs. Placebo

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT04753567

Run by

nCap Medical

People needed

70

Starts

2021-04-16

Expected to finish

2022-04-01

Last updated by the study team

2021-04-20

Who can join

Age: 40 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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+)

Where it is running

• Knee Arthritis Clinical Trial Officew — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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