Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis
Condition: Osteo Arthritis Knee; Arthritis
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee
Intervention: Sustained Acoustic Device with 1% Diclofenac patch
Intervention description: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch
Other Names:
ZetrOZ ultrasound device
wearable ultrasound device
long duration ultrasound
LITUS device
long duration low intensity device
Intervention MeSH terms: Diclofenac
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: low-intensity ultrasound; drug delivery; sonophoresis; transdermal drug delivery; Non-Steroidal anti-inflammatory Drugs; sustained acoustic medication; low intensity continuous ultrasound

Summary:

      The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine
      (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II
      and stage III knee osteoarthritis. The ability of the device to reduce pain, increase
      mobility, increase function of the affected leg, and improve quality of life in patients with
      knee osteoarthritis will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) 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

          -  45-85 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 1% diclofenac 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)