Real-World Experience of Athletes Treated With SAM

Study Overview
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Brief Summary
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Low-intensity continuous ultrasound (LICUS) is an FDA-approved bio regenerative technology, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. This report included a retrospective convenience sample of 6 athletes from one sports medicine and rehabilitation facility. The objective of this report is to examine the real-world outcome data on symptoms improvement and return to function using Sam. It was hypothesized that LICUS stimulation, in conjunction with traditional therapies, will accelerate the healing process of musculoskeletal tissue leading to a reduction in pain, increase functionality, and a higher probability of returning to work and sports-related activities. The sample included athletes with sports-related musculoskeletal injuries. Demographics, injury history, treatment history, and clinical outcomes data were retrospectively collected for athletes who were treated with SAM in conjunction with traditional therapies. Clinical results showed a benefit from the treatment with a decrease in pain (100%), and 3 out of 6 athletes were able to return to work or sports (50%). Overall the study shows that Sam accelerates the healing of soft tissue leading to a decrease in both acute and chronic pain.

Detailed Description
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The cohort of 6 male athletes (n=6) ages ranged from 18 to 54 years of age, with an average age of 33.5 years with musculoskeletal injuries, which showed little or no improvement with traditional therapies selected from one rehabilitation facility. The group included 3 amateur athletes and 3 professional athletes participated in baseball (2) and golf (1). No healthy athlete was selected, considering the study of nature. Demographic, injury history, treatment history, and clinical outcomes data of the patients were collected. The patients were asked about the effectiveness of traditional therapies such as physical therapy, manual therapy, a combination of rest, ice, compression, and elevation (RICE). The athletes with sports-related musculoskeletal related injuries, including arm, upper leg, back, quadriceps, knees, foot/ankles, were treated with low-intensity continuous ultrasound (SAM®, ZetrOZ Sysmtem LLC device) in conjunction with traditional therapies. At that point, data were recorded, and patients were advised to use LICUS in conjunction with conventional therapies. The athletes were asked about the effectiveness of LICUS treatment as an add-on to traditional therapies. Furthermore, .the effectiveness of the treatment was assessed by patient response to pain relief, range of motion, and ability to going back to the sport. The LICUS was delivered by easy to use wearable LICUS device (SAM®, ZetrOZ Systems, LLC, Trumbull, CT) consisting of two transducers powered by an external battery pack was used to deliver at 3MHz, 0.132W/cm2, 1.3W for 4 hours. The athletes were trained to use the device using ultrasound coupling gel on the injured area. It was ensured that all the athletes knew how to use the device properly. The device is easy to use with three buttons setup: an on/off button (middle), a time, and on/off lock buttons on the sides.

Official Title
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Efficacy of SAM Sport as an Addon to Traditional Therapy in Treating Sports-related Injuries

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

Intervention / Treatment
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* Device: Low Intensity Continuous Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Athletes with musculoskeletal injuries with limited improvement under traditional therapies Exclusion Criteria: Healthy Athletes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 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>Retrospective analysis of pain alleviation, range of motion and ability to return to work with traditional therapies selected from one rehabilitation facility | |
| Post-Low Intensity Continuous Ultrasound Treatment<br>Retrospective analysis 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 selected from one rehabilitation facility | Device: Low Intensity Continuous Ultrasound<br>* 3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC<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. A total of 6 athletes were examined through questionnaires. in which they were asked about the change of pain on the NRS scale. No adverse effects were reported throughout the study. | variable (1 - 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-intensity ultrasound, continuous ultrasound, long-duration ultrasound, athletic training, clinical trial, soft tissue, pain, Musculoskeletal tissue, ZetrOZ System LLC