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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actual pain patch | Experimental |
| |
| Sham patch | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nCap pain relief patch | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score using VAS scale | 0-10 pain scale | After 30 minutes of use |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC score | arthritis assessment score | 3 weeks |
| Sustained pain response | 0-10 VAS pain score | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatjana Warren, PhD CRNA | Contact | 8584051003 | tsbevans@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knee Arthritis Clinical Trial Officew | Recruiting | Salt Lake City | Utah | 84107 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Sham Patch | Device | Sham patch will be worn for 3 weeks exactly like actual pain patch |
|
| Global assessment question | How the patient feels they are doing | 3 weeks |
| Pain medication monitoring | Tylenol use | 3 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |