Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Reducing Pain and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- CyMedica Orthopedics, Inc
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS) pain level
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic Kellgren-Lawrence (KL) Grade 2, 3, or 4 OA by radiograph (AP tunnel view) within 30 days prior to day 0 visit, where the K-L grades are defined as:
- •Grade 0: no radiographic features of OA are present
- •Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
- •Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph
- •Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
- •Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
- •Patients who are between the ages of 18 - 85 years
- •Patient has signed informed consent
- •Patient has access to a smartphone or tablet (Android or iOS)
- •Subject must be ambulatory.
Exclusion Criteria
- •Subjects who have a body mass index \> 40 at the time of consent. Exclusion of a patient with BMI\>40 is up to the discretion of the PI.
- •Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.).
- •Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded.
- •Subject must NOT have had arthroscopy within 8 weeks of randomization.
- •Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening.
- •Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of screening.
- •Subjects who have had a scheduled surgery on the target knee within the study period.
- •(Note- Patients who are scheduled to go under surgery within the next 6 months will be excluded. Patients that are contemplating the surgery can be included.)
- •Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening
- •Subjects with significant and clinically evident mal-alignment of the target knee (\> 10 degrees varus or valgus in the target knee).
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS) pain level
Time Frame: 12 weeks post intervention
Worst pain walking
Secondary Outcomes
- Activity(12 weeks post intervention)
- Pain related medication(12 weeks post intervention)
- Knee injections(12 weeks post intervention)
- TUG(12 weeks post intervention)
- Stair climb(12 weeks post intervention)
- Ambulation assist devices(12 weeks post intervention)
- Quadriceps strength(12 weeks post intervention)
- 6 min walk test(12 weeks post intervention)
- Physical therapy(12 weeks post intervention)
- Plan for TKA surgery(12 weeks post intervention)
- Repeated chair rise(12 weeks post intervention)