Status:
UNKNOWN
nCap Pain Relief Patch vs. Placebo
Lead Sponsor:
nCap Medical
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-79 years
Phase:
NA
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- 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+)
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04753567
Start Date
April 16 2021
End Date
April 1 2022
Last Update
April 20 2021
Active Locations (1)
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1
Knee Arthritis Clinical Trial Officew
Salt Lake City, Utah, United States, 84107