Clinical trial: Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients (NCT03980964)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment