Clinical trial: Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee (NCT02436590)

Eligibility criteria:
Inclusion Criteria:

          1. Subject must be able to wear the investigational device so that there is adequate PEMF
             exposure to the knee.

          2. Subject must have a body mass index ≤ 45 at the time of consent.

          3. Subject must be at least forty (≥ 40) years of age of age at the time of consent.

          4. Subject must have an established diagnosis of primary femorotibial OA in the target
             knee by modified American College of Rheumatology criteria for at least 6 months and
             at least one of the following:

             i. Stiffness less than 30 min ii. Crepitus (noise or cracking on knee motion)

          5. Subject must have symptomatic Kellgren-Lawrence (K-L) Grades 1-3 OA by radiograph (PA
             flexion) within 90 days of screening, where the K-L grades are defined as:

             Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2:
             definite osteophytes and definite narrowing of joint space; Grade 3: moderate multiple
             osteophytes and definite narrowing of joint space and some sclerosis and possible
             deformity of bone contour

          6. Subject must have a visual analog pain score between 4 cm and 8 cm on a 10 cm scale in
             the target knee at the time of screening.

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

          8. Subject must be ambulatory.

          9. Subject must NOT have had arthroscopy within 8 weeks of randomization.

         10. Subject must NOT have had viscosupplementation within 8 weeks of randomization.

         11. Subject must NOT have had NSAIDs within 1 week of randomization (low-dose aspirin as
             cardioprotective prophylaxis is permitted).

         12. Subject must be willing to discontinue corticosteroids administered by any route
             except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.

         13. Subject must be willing to take acetaminophen (up to 3000 mg/day) as pain medication
             for the duration of the study. Other pain medications may be allowed during the course
             of the study if the subject meets specific criteria.

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

         15. 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.

         16. Subjects must be proficient in English.

         17. Subject must be willing and able to sign an informed consent document.

         18. 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 > 45 at the time of consent.

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

          3. Subjects with a diagnosis of secondary arthritis (acromegaly, Charcot's arthropathy,
             hemochromatosis, Wilson's disease, ochronosis, etc.).

          4. Subjects with confounding factors such as ipsilateral hip OA or chronic pain syndromes
             (fibromyalgia, Crohn's disease, ulcerative colitis, interstitial cystitis).

          5. Subjects who have had an injury or an acute traumatic injury to the index knee within
             6 months of screening will be excluded.

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

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

          8. Subjects who plan to have surgery on the target knee within the study period.

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

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

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

         12. Subjects with pain in any other area of the lower extremities or back that is equal to
             or greater than the pain in the target knee.

         13. Subjects who have contraindications to MRI and X-rays, for example, implanted
             electrical devices (cardiac pacemakers, deep brain stimulators).

         14. 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.

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

         16. Subjects with skin breakdown or infection in the area where the study device will be
             placed.

         17. 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.

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

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

         20. Subjects who are unwilling or unable to adhere to the follow up schedule and
             procedures.

         21. Subjects who are pregnant.

         22. Subjects who are prisoners.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


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? Contradiction