NCT04367597

Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: CyMedica Orthopedics, Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Home-based Neuromuscular Electrical Stimulation (NMES) therapy	A home-based NMES treatment applied by the subjects daily

Timeline

• Start date: 2020-04-20
• Primary completion: 2020-08-20
• Completion: 2021-03-16
• First posted: 2020-04-29
• Last updated: 2021-03-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study