NCT05254470

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: ZetrOZ, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuous Ultrasound	3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2022-02-24
• Last updated: 2022-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study