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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAM Ultrasound Diathermy Device | Experimental | SAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAM Ultrasound Diathermy Device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain (Numeric Rating Scale; NRS) | Change from Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (NRS): 50% response rate | Week 6 | |
| Pain (NRS) during treatment session | Pre-treatment to Post-treatment (4 hours) | |
| Grip Strength (dynamometer) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZetrOZ, Inc. | Trumbull | Connecticut | 06611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26468991 | Derived | Best TM, Moore B, Jarit P, Moorman CT, Lewis GK. Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy. Phys Sportsmed. 2015 Nov;43(4):366-74. doi: 10.1080/00913847.2015.1095617. Epub 2015 Oct 15. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| Change from Baseline to Week 6 |
| Treatment Compliance (subject-reported use of device compared to protocol) | weekly through Week 6 |