Long Duration Therapeutic Ultrasound for Tendon Healing

Study Overview
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Brief Summary
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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.

Official Title
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Long Duration Therapeutic Ultrasound for Tendon Healing

Conditions
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Tendinopathy, Tendinitis, Tendinosis

Intervention / Treatment
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* Device: SAM Ultrasound Diathermy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18-65 years of age, inclusive Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon, or patellar tendon based on examination of medical history and confirmed by physical examination including either manual movements of the injured limb, e.g., a positive Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon; Body mass index (BMI) less than or equal to 30.0 Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to document all pain medication use during the study period. Exclusion Criteria: History or current diagnosis of tendon tear in treated tendon Known neuropathy Type I or Type II diabetes mellitus Had surgery in target treatment area within 6 months Refuse to agree to not increase current use or initiate new use of pain medication during the trial unless medically necessary to ensure patient safety Refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided Refuse to discontinue all other interventional treatment modalities (e.g., transcutaneous electrical nerve stimulation, other ultrasound therapy, etc.) Have had a local corticosteroid or platelet-rich plasma injection within the past 3 months Have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAM Ultrasound Diathermy Device<br>SAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks | Device: SAM Ultrasound Diathermy Device<br> <br> * Other names: SAM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Numeric Rating Scale; NRS) |  | Change from Baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | Change from Baseline to Week 6 | 
| Treatment Compliance (subject-reported use of device compared to protocol) |  | weekly through Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sustained acoustic medicine, therapeutic ultrasound, SAM, LITUS