Long Duration Therapeutic Ultrasound on Tendon Injuries

The ability of long duration therapeutic ultrasound to reduce pain, increase strength, and
improve quality of life for patients with tendon injury [e.g. tendinopathy of the elbow
(medial or lateral], Achilles tendon, or patellar tendon) will be assessed. During the
7-week protocol, participants will receive 4 continuous hours of therapy daily.

For the first week, baseline data will be collected as participants report pain scores (VAS)
in the morning, noon, and night. During the next 6 weeks, participants will self-apply the
device each day and record their pain score (VAS) before and treatment; and record their
pain score (VAS) while performing specified movements designed to evaluate tendon
rehabilitation. At bi-weekly site visits, strength measurements will be performed on the
injured and uninjured limb. Participants will also complete a standardized questionnaire to
assess disability due to the specific tendon injury at baseline and study conclusion.

Inclusion Criteria:

- Has been diagnosed with tendinitis in the elbow (medial or lateral epicondyles),
patella, or Achilles tendon based on physical examination by a healthcare
practitioner and medical history. Physical examination must include one of the
following: assessment of pain during manual movements of the injured limb (e.g. a
positive Mill's Test [Wadsworth, 1987] for elbow tendinitis), or local tenderness
upon palpation over the tendon

- Experience tendon pain greater than 1 (using the VAS scale of 0-10) during the week
preceding study screening

- Between 18 and 70 years of age

- Willing and able to self-administer the study device to the treatment area daily

- Have access to a mobile phone or camera to take a picture of the treatment area
immediately after use of the device

- Body Mass Index (BMI) is less than or equal to 34.0

- Agree to document all pain medications and associated dosages during participation in
the study.

- If taking prescription pain medication, agree to keep dosage constant (unchanged)
during participation in the study.

- Agree not to use any topical solution such as analgesic cream or ointment on the
treatment area during participation in the study

Exclusion Criteria:

- Subjects that cannot speak, read or write English

- History or current diagnosis of tendinosis or a tendon tear

- Known neuropathy (nerve damage that affects the treatment area)

- Surgery in the treatment area within the last 6 months

- Non-ambulatory (unable to walk)

- Prisoner

- Pregnant

- Have a pacemaker

- Malignancy in the treatment area

- Refuse to discontinue all other interventional treatment modalities (i.e.
transcutaneous electrical nerve stimulation (TENS), electrical stimulation, or other
ultrasound therapy) during the study

- Local corticosteroid or platelet-rich plasma (PRP) injection within the past 3 months

- Clinically significant or unstable medical or psychological conditions that would
compromise participation in the study

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

- Involved in any injury-related litigation in the treatment area

- Open sores or wounds in the treatment area that would prevent use of the device

- Arthritis in the treatment area

- Carpal tunnel syndrome (if subject has elbow tendinitis)