Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients
CompletedNot applicableNCT03980964
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Reducing Pain and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients
- Interventions
- Device: Active NMES
- Sponsor
- CyMedica Orthopedics, Inc
- Start date
- 2019-06-07
- Primary completion
- 2020-05-22
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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 2. Patients who are between the ages of 18 - 85 years 3. Patient has signed informed consent 4. Patient has access to a smartphone or tablet (Android or iOS) 5. Subject must be ambulatory. 6. Subject must be willing to stop taking any pain medications 24 hours prior any scheduled study visit. 7. Subjects must be proficient in English. 8. Subject must be willing and able to sign an informed consent document. 9. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study. Exclusion Criteria: 1. 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. 2. Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.). 3. Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded. 4. Subject must NOT have had arthroscopy within 8 weeks of randomization. 5. Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening. 6. Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of screening. 7. 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.) 8. Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening 9. Subjects with significant and clinically evident mal-alignment of the target knee (\> 10 degrees varus or valgus in the target knee). 10. Subjects with surgical metallic hardware in the target knee. 11. Subjects who have contraindications to MRI and X-rays, for example, implanted electrical devices (c…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03980964