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Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:
A Roll-over Study of CM-2019 Trial (A Randomized, Sham Controlled, Double-blind, Multi-center Study of Neuromuscular Electrical Stimulation (NMES) as an Adjunctive Therapy for Knee Pain Relief and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients)

Clinical Trial Summary

A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.

Clinical Trial Description

This roll-over study is designed as a 14-week treatment continuation from CM-2019 (parent study), a randomized, sham controlled, double-blind, multi-center study trial to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) as an adjunctive therapy for pain relief and accelerating functional recovery in patients with knee osteoarthritis. This follow-up trial will include subjects who have been randomized into the CM-2019 trial. Subjects will be enrolled into the appropriate treatment group based upon the treatment received in the parent study. It is hypothesized that the continued use of CyMedica e-vive NMES may provide additional pain relief and improved knee function for an additional 14 weeks compared to sham. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04367597
Study type Interventional
Source CyMedica Orthopedics, Inc
Contact
Status Completed
Phase N/A
Start date April 20, 2020
Completion date March 16, 2021
View Details
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