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OpenTrials
Completed

NCT Number: NCT05254470

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

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.

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Key information

Conditions

Musculoskeletal Injury Acute Pain Arm Injuries Arm Injury Back Pain Chronic Pain Muscle Injury Neurologic Manifestations Pain Pain, Acute Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms Soft Tissue Injuries Sport Injury Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sport & Orthopaedic Physical Therapy

Fairfield, Connecticut, 06824, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Work-related musculoskeletal injuries with limited improvement under traditional therapies

Exclusion criteria

  • Healthy participant

Treatment and study plan

Continuous Ultrasound

Device

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

Primary outcomes

  1. Numeric Pain Rating Scale (NRS) (0-10)

    Time frame: 0 - 4 weeks

    Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain.

Secondary outcomes

  1. Global Health Improvement Score (GROC) (-7 to +7)

    Time frame: 0 - 4 weeks

    Quality of health care improvement satisfaction from intervention compared to conservative treatment

Sponsors and collaborators

Lead sponsor

ZetrOZ, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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