Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial

This is an eight week study to clinically evaluate the effect of the low intensity long
duration ultrasound (LITUS) device on symptoms of patients suffering from knee
osteoarthritis. The device, sam® has been FDA-cleared for use. For the first two weeks of the
study, baseline data will be collected as patients report pain scores (NRS) three times per
day. During the following 6 weeks, patients will self-apply the wearable LITUS device to
their affected knee for 4 hours daily. Each day of the study, pain scores (NRS) will be
recorded immediately before application of LITUS device as well as 30 minutes, 2-hours and
4-hours after applying the device. A quality of life assessment (WOMAC), muscle strength and
range of motion assessment (JTech) will be performed prior to the patient beginning the
protocol and at the conclusion of the protocol.

Up to 93 subjects will be recruited from neighboring communities to the study site. The study
is designed to reach a target patient population which includes rural citizens and
socioeconomic disadvantaged individuals where non-pharmacotherapies do not exist to manage
pain. Subjects will be randomly assigned to active (60%) and placebo groups (40%). The
sponsor and investigators are blinded as to which type of device each patient is assigned.

The study will be monitored by an external monitor and a data safety monitoring board (DSMB).

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)