ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
ZetrOZ, Inc.
Trumbull, Connecticut, United States
Pain (Numeric Rating Scale; NRS)
Time frame: Change from Baseline to Week 6
Pain (NRS): 50% response rate
Time frame: Week 6
Pain (NRS) during treatment session
Time frame: Pre-treatment to Post-treatment (4 hours)
Grip Strength (dynamometer)
Time frame: Change from Baseline to Week 6
Treatment Compliance (subject-reported use of device compared to protocol)
Time frame: weekly through Week 6
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