A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
A home-based NMES treatment applied by the subjects daily
Noble Clinical Research
Tucson, Arizona, United States
Tucson Orthopedic Institute
Tucson, Arizona, United States
Synergy Group US LLC
Houston, Texas, United States
Synergy Group US LLC
Katy, Texas, United States
Knee pain
Assessment of knee pain relief associated with knee osteoarthritis using VAS instrument scale
Time frame: 14 weeks post intervention
Knee pain and function
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using WOMAC survey
Time frame: 14 weeks post intervention
Knee pain and function
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using KOOS Jr. survey
Time frame: 14 weeks post intervention
Knee function
Knee functional improvements including quadriceps strength tes
Time frame: 14 weeks post intervention
Knee function
Knee functional improvements including Timed Up and Go test
Time frame: 14 weeks post intervention
Knee function
Knee functional improvements including 3 Min walk test
Time frame: 14 weeks post intervention
Knee function
Knee functional improvements including Repeated chair rise test
Time frame: 14 weeks post intervention
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Synergy Group US LLC
Missouri City, Texas, United States