Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care

Study Overview
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Brief Summary
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The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow. Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.

Detailed Description
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ZetrOZ's SAM Ultrasound Device is a portable and wearable medical device which, when applied to various areas of the body, applies Low Intensity Therapeutic Ultrasound to deep tissues. The SAM device is currently used by a broad range of Athletic Trainers (ATs) in the United States to assist in the rehabilitation of injured athletes. The purpose of this this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care. This includes understanding utilization of the treatment (how often and how much time), how the treatment helps patients (rehabilitation and recovery), and information on SAM treatment augmenting conservative therapies.

Official Title
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Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care

Conditions
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Musculoskeletal Injury, Pain, Chronic, Pain, Acute, Sport Injury, Soft Tissue Injuries, Arm Injury, Back Pain, Tendon Injuries, Muscle Injury

Intervention / Treatment
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* Device: Continuous Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Work-related musculoskeletal injuries with limited improvement under traditional therapies Exclusion Criteria: Healthy participant

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Low Intensity Continuous Ultrasound Treatment<br>Routine care for pain alleviation, range of motion and ability to return to work with traditional therapies from rehabilitation. | |
| Post-Low Intensity Continuous Ultrasound Treatment<br>Routine care of pain alleviation, range of motion and ability to return to work after treatment with low-intensity continuous ultrasound (LICUS) in conjunction with traditional therapies. | Device: Continuous Ultrasound<br>* 3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NRS) (0-10) | Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain. | 0 - 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Health Improvement Score (GROC) (-7 to +7) | Quality of health care improvement satisfaction from intervention compared to conservative treatment | 0 - 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Contiguous Ultrasound, Pain, Soft Tissue Injury