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Real-World Experience of Athletes Treated With SAM

NCT04177537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2019-11-26

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Low Intensity Continuous Ultrasound

3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC

Sponsors & Collaborators

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • David O Draper, EdD · Brigham Young University

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2015-10-31
Completion
2015-10-31
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177537 on ClinicalTrials.gov