Clinical trial: Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain (NCT04128618)

Eligibility criteria:
Inclusion Criteria:

          1. Subject must provide written, informed consent before any study procedures occur. The
             subject should be provided with a copy of the signed Informed Consent upon signature.

          2. Subjects 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

          3. Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm
             confirmed by radiograph.

          4. Subjects who are between the ages of 21 - 85 years.

          5. Subjects must have a visual analog pain (VAS) score of at least 4 cm on a 10 cm scale
             for a nominated activity in the target knee at the time of screening.

          6. For bilateral knee osteoarthritis subjects, the visual analog pain VAS score for a
             nominated activity of the contralateral knee must be less than 4 cm on the VAS scale.

          7. Subject has access to a smartphone or tablet (Android or iOS).

          8. Subject must be ambulatory.

          9. Subject must be willing to discontinue receiving knee intra-articular injections of
             steroids, knee intra-articular injections of hyaluronic acid, opioids, and analgesics
             (except for acetaminophen up to 3000 mg/day or an equivalent) for the duration of the
             study.

         10. Subject must be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as
             pain medication for the duration of the study.

         11. Subject must be willing to stop taking any pain medications 24 hours prior any
             scheduled study visit.

         12. Subject must be willing to stop receiving knee physical therapy of the target knee for
             the duration of the study.

         13. Subject must be willing to stop wearing any knee unloader brace of the target knee for
             the duration of the study.

         14. Subjects must be proficient in English.

         15. 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 (at the discretion of
             the PI).

          2. Subjects with a diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active
             gout, knee joint infection, Lyme disease, SLE, etc.).

          3. Subjects with a diagnosis of severe neuropathy condition for the past 6 months and
             under medication for treatment of the condition.

          4. Subjects with a diagnosis of fibromyalgia for the past year.

          5. Subjects who have had an injury or an acute traumatic injury to the target knee within
             6 months of screening.

          6. Subject must NOT have had arthroscopy of the target knee within 8 weeks of
             randomization.

          7. Subjects who have had treatment of the target knee with intra-articular injections of
             steroids within 8 weeks of screening.

          8. Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of
             screening.

          9. Subjects who have had a scheduled surgery on the target knee within the study period.

             (Note- Subjects who are scheduled to go under total knee replacement surgery within
             the next 3 months at screening will not be enrolled. Subjects that are contemplating
             the surgery can be included.)

         10. Subjects who have used electrotherapy or acupuncture for OA of the target knee within
             4 weeks of screening.

         11. Subjects who have used Neuromuscular Electrical Stimulation (NMES) in the past year.

         12. Subjects with significant and clinically evident mal-alignment of the target knee (> 5
             degrees varus or valgus in the target knee).

         13. Subjects with surgical metallic hardware in the target knee.

         14. Subjects who have had implanted electrical devices (cardiac pacemakers, deep brain
             stimulators, implantable cardiac defibrillators).

         15. Subjects who have contraindications to X-rays.

         16. 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.

         17. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of
             chronic substance abuse (> 5 years).

         18. Subjects with skin breakdown or infection in the area where the study device will be
             placed (quadriceps of the target knee).

         19. 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.

         20. Subjects who have any ongoing litigation for worker's compensation.

         21. Subjects with any condition, in the opinion of the Investigator that might interfere
             with the evaluation of the study objectives.

         22. Subjects who are pregnant.

         23. Subject must not have participated in a clinical study within the past 12 weeks from
             the last day of treatment 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 21 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment