Real-World Experience of Athletes Treated With SAM

November 22, 2019 updated by: ZetrOZ, Inc.

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

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Athletes with sport-related musculoskeletal injuries.

Description

Inclusion Criteria:

  • Athletes with musculoskeletal injuries with limited improvement under traditional therapies

Exclusion Criteria:

  • Healthy Athletes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-Low Intensity Continuous Ultrasound Treatment
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
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
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NRS) (0-10)
Time Frame: variable (1 - 8 weeks)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to Work on the scale of number of week
Time Frame: variable (1 - 8 weeks)
Athletes reported response to a questionnaire, implying the return to sporting activity, the lowest number of weeks means quicker recovery and a higher number of weeks meant the lowest recovery
variable (1 - 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: David O Draper, EdD, Brigham Young University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 31, 2015

Study Completion (Actual)

October 31, 2015

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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