nCap Pain Relief Patch vs. Placebo

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: nCap pain relief patch
* Device: Sham Patch


Participation Criteria
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Eligibility Criteria
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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+)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actual pain patch<br> | Device: nCap pain relief patch<br>* Each participant will be randomly assigned to sham or actual patch. Patches will be worn for 3 weeks. Pain and quality of life will be assessed and compared between groups<br>|
| Placebo Comparator: Sham patch<br> | Device: Sham Patch<br>* Sham patch will be worn for 3 weeks exactly like actual pain patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score using VAS scale | 0-10 pain scale | After 30 minutes of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC score | arthritis assessment score | 3 weeks | 
| Sustained pain response | 0-10 VAS pain score | 3 weeks | 
| Global assessment question | How the patient feels they are doing | 3 weeks | 
| Pain medication monitoring | Tylenol use | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, arthritis