Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients
Condition: Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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.
    

Detailed description: 
      The study will be conducted at Lenox Hill Hospital, Northwell Health, located in New York,
      New York, and involve a total of 120 patients. All study patients will be evenly divided into
      two groups: (a) conductive garment and mobile app with NMES therapy; (b) conductive garment
      and mobile app without NMES therapy (sham).

      Eligible patients will be evaluated according to the time and events schedule. Clinical
      outcomes will be assessed from 1 to 10 days before day of intervention and followed up after
      intervention over a 24 weeks ± 1 week study period.

      These two groups will be analyzed using several outcome measures including validated
      patient-reported outcome measures including Visual Analogue Scale (VAS) pain level, the Knee
      Injury and Osteoarthritis Outcome Score (KOOS) JR., KOOS ADL, and WOMAC survey. Functional
      measures include isometric quadriceps strength, Time Up and Go (TUG), 6 minute walk test,
      repeated chair rise test, stair climb test, and number of steps recorded by an Apple Watch
      Series 3 or a Samsung watch. Reduction of use of anti-inflammatory medications (NSAIDS) and
      narcotics, use of ambulation assist devices, plan for TKA procedure survey, device compliance
      use, and patient satisfaction survey will be tracked The primary endpoint for the study is
      Visual Analogue Scale (VAS) pain The proprietary app for this product will be used to track
      device usage (intensity, duration of session, frequency of use), VAS, WOMAC, and KOOS JR.
    

Intervention name(s): Active NMES
Intervention type(s): Device
Intervention description(s): Daily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-way crossover- Patients from the control cohort are allowed to crossover to the treatment cohort after 12 weeks of study enrollment, if a subject would request receiving knee intra-articular injections of hyaluronic acid (HA) or corticosteroids (CS) or opioids. Patients are also allowed to crossover to the treatment arm if they decide to drop out of the study due to the potential lack of clinical benefits from the sham treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NMES; arthritis; knee pain; osteoarthritis; electrical stimulation therapy