Osteoarthritis, Knee Clinical Trial
Official title:
nCap Medical Nano-Capacitive Pain Relief Patch vs Placebo, a Prospective Randomized Controlled Trial
NCT number | NCT04753567 |
Other study ID # | 00127554 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 16, 2021 |
Est. completion date | April 2022 |
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 79 Years |
Eligibility | 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+) |
Country | Name | City | State |
---|---|---|---|
United States | Knee Arthritis Clinical Trial Officew | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
nCap Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score using VAS scale | 0-10 pain scale | After 30 minutes of use | |
Secondary | WOMAC score | arthritis assessment score | 3 weeks | |
Secondary | Sustained pain response | 0-10 VAS pain score | 3 weeks | |
Secondary | Global assessment question | How the patient feels they are doing | 3 weeks | |
Secondary | Pain medication monitoring | Tylenol use | 3 weeks |
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