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

NCT05254470 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2022-02-24

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Continuous Ultrasound

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

Sponsors & Collaborators

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • Rod Walters, EdD · Walters Sports Medicine Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05254470 on ClinicalTrials.gov