nCap Pain Relief Patch vs. Placebo

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: nCap pain relief patch; Device: Sham Patch

• Registration Number: NCT04753567
• Lead Sponsor: nCap Medical

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 physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Status Verified: 2021-04
• Study Start: 2021-04-16
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-20
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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+)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actual pain patch	nCap pain relief patch	-
Sham patch	Sham Patch	-

Primary Outcome Measures

Name	Time	Method
Pain score using VAS scale	After 30 minutes of use	0-10 pain scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Knee Arthritis Clinical Trial Officew; 🇺🇸 Salt Lake City, Utah, United States