Musculoskeletal Injury, Pain, Chronic, Pain, Acute, Sport Injury, Soft Tissue Injuries, Arm Injury, Back Pain, Tendon Injuries, Muscle Injury
Conditions
Keywords
Continuous Ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Contiguous Ultrasound, Pain, Soft Tissue Injury
Brief 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.
Interventions
DEVICEContinuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device
Sponsors
ZetrOZ, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Work-related musculoskeletal injuries with limited improvement under traditional therapies
Exclusion criteria
* Healthy participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NRS) (0-10) | 0 - 4 weeks | Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Health Improvement Score (GROC) (-7 to +7) | 0 - 4 weeks | Quality of health care improvement satisfaction from intervention compared to conservative treatment |
Countries
United States
Outcome results
None listed