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

ZetrOZ

Status: Completed

Conditions: Muscle Injury; Back Pain; Arm Injury; Soft Tissue Injuries; Musculoskeletal Injury; Pain, Acute; Sport Injury; Pain, Chronic; Tendon Injuries

Treatments: Device: Continuous Ultrasound

Study type: Observational

Funder types: Industry

Identifiers

NCT05254470

CS-02-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Healthy participant

Trial design

135 participants in 2 patient groups

Pre-Low Intensity Continuous Ultrasound Treatment

Description:

Routine care for pain alleviation, range of motion and ability to return to work with traditional therapies from rehabilitation.

Post-Low Intensity Continuous Ultrasound Treatment

Description:

Routine care 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.

Treatment:

Device: Continuous Ultrasound