Clinical trial: Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis (NCT01993693)

Eligibility criteria:
Individual will be included if they:

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

          2. are between 35-65 years of age

          3. report a frequent pain score between 4-7 (range: 0-10) during the week preceding
             enrollment

          4. report mobility limitations because of their knee pain

          5. are currently not taking any prescription pain medication other than nonsteroidal
             antiinflammatory drugs (NSAIDs). All pain medication taken during the study should be
             documented.

          6. are 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

          7. are deemed appropriate by their physician to participate.

        Individuals will be excluded if they:

          1. cannot successfully demonstrate the ability to put on and take off the device

          2. are cognitively impaired

          3. have bone-on-bone crepitus

          4. have severe OA or patients with little to no cartilage on the knee

          5. have knee replacement or other surgical intervention

          6. take variable prescription medication

          7. are non-ambulatory

          8. participated in a clinical trial for an investigational drug and/or agent within 30
             days prior to screening

          9. are currently taking neuropathic medications (ie: Neurontin, Lyrica or Topamax) and/or
             antidepressants (ie: Amitriptyline).
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