Clinical trial: Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial (NCT02083861)

Eligibility criteria:
Inclusion Criteria:

          -  Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2)
             based on fixed-flexion x-ray radiological findings for osteophytes and joint space
             narrowing within the past 12 months

          -  Fulfill the American College of Rheumatology clinical and radiological diagnostic
             criteria for knee OA

          -  35-80 years of age

          -  Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding
             enrollment

          -  Report that knee pain negatively affects quality of life

          -  Willing not to use any cream, gel, or topical solution during the administration of
             treatment other than the approved ultrasound gel provided to the subject at the
             initiation of the study

          -  Deemed appropriate by their physician or by the study site physician to participate

        Exclusion Criteria:

          -  Cannot successfully demonstrate the ability to put on and take off the device

          -  Display any condition which, in the judgment of the investigator, would make
             participation in the study unacceptable, including, but not limited to, the subject's
             ability to understand and follow instructions.

          -  Have severe OA or have little to no cartilage in the knee

          -  Have knee replacement, other surgical intervention, or hyaluronidase injection in the
             affected knee in the past 6 months

          -  Are non-ambulatory

          -  Participated in a clinical trial for an investigational drug and/or agent within 30
             days prior to screening

          -  Modify their medications during the course of the study (medications and doses must
             remain constant throughout the study)

          -  Currently taking steroids

          -  Have contraindication to radiograph

          -  Have a secondary cause of arthritis (metabolic or inflammatory)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 80 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