Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients
NCT03980964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-05-21
Summary
The present prospective trial is designed to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) for reducing pain and accelerating functional recovery in patients with knee osteoarthritis. This post-market trial will involve patients who have been diagnosed with knee osteoarthritis, Kelgren-Lawrence Grades II, III, and IV. It is hypothesized that the use of the CyMedica e-vive NMES can reduce pain, improve knee function, and improve quality of life.
Conditions
- Knee Osteoarthritis
- Knee Pain Chronic
- Knee Arthritis
Interventions
- DEVICE
-
Active NMES
Daily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy
Sponsors & Collaborators
-
CyMedica Orthopedics, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-06-07
- Primary Completion
- 2020-05-22
- Completion
- 2021-04-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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