Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients (NMES)

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring NMES, arthritis, knee pain, osteoarthritis, electrical stimulation therapy Read More

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 (cardiac pacemakers, deep brain stimulators).
12. Subjects with a current malignancy or who have received treatment for malignancy with the last 5 years, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
13. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of chronic substance abuse (> 5 years).
14. Subjects with skin breakdown or infection in the area where the study device will be placed.
15. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) that have not been well-controlled for at least 3 months prior to screening.
16. Subjects who have any ongoing litigation for worker's compensation.
17. Subjects with any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
18. Subjects who are pregnant.
19. Subject must not have participated in a clinical study within the past 12 weeks that required the use of an investigational device, drug or biologic