Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis

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.

Inclusion criteria

• Subject must provide a signed informed consent for CM-2019R. The subject will be provided with a copy of the signed Informed Consent upon signature.
• Currently enrolled in the parent trial CM-2019 or have successfully completed the parent trial within 21 days of enrollment in the roll-over trial.
• Willing and able to continue parent trial study treatment.
• Pregnancy test, if it has been >14 days since completion of the parent trial.
• Subject must continue to be willing to refrain from receiving knee intra-articular injections of steroids, knee intra-articular injections of hyaluronic acid, opioids, and analgesics (except for acetaminophen up to 3000 mg/day or an equivalent) for the duration of the study.
• Subject must continue to be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.
• Subject must continue to be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
• Subject must continue to be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
• Subject must continue be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
• Subjects must be willing and able to comply with all study procedures for the duration of the clinical study

Exclusion criteria

• Subjects with a new diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.) since parent trial enrollment.
• Subjects with a new diagnosis of severe neuropathy condition and under medication for treatment of the condition since parent trial enrollment.
• Subjects with a new diagnosis of fibromyalgia since parent trial enrollment.
• Subjects who have had an injury or an acute traumatic injury to the target knee since parent trial enrollment.
• Subject must NOT have had arthroscopy of the target knee since parent trial enrollment.
• Subjects who have had treatment of the target knee with intra-articular injections of steroids since parent trial enrollment. Subjects who have had intra-articular injections of hyaluronic acid since parent trial enrollment.
• Subjects who have a scheduled surgery on the target knee within the study period. (Subjects that are contemplating the surgery can be included.)
• Subjects who have used electrotherapy or acupuncture for OA of the target knee since parent trial enrollment year.
• Subjects who have had implanted electrical devices since parent trial enrollment (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).
• Subjects with a current new malignancy or who have received treatment for malignancy since parent trial enrollment, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
• Subjects with a new skin breakdown or infection in the area where the study device will be placed (quadriceps of the target knee).
• Subjects with any newly reported chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) or that have not been well-controlled during the parent trial.
• Subjects who have any new litigation for worker's compensation.
• Subjects with any new condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
• Subjects who are pregnant.
• Subject who enrolled in any new clinical study from the last day of treatment in the parent trial that required the use of an investigational device, drug or biologic.