Clinical trial NCT05254470: Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
Official title: Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Injury
Pain, Chronic
Pain, Acute
Sport Injury
Soft Tissue Injuries
Arm Injury
Back Pain
Tendon Injuries
Muscle Injury
Keywords: Continuous Ultrasound
Sustained Acoustic Medicine
Musculoskeletal Injuries
Low Intensity Contiguous Ultrasound
Pain
Soft Tissue Injury
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with work and sport related musculoskeletal injuries

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Healthy participant

Primary outcomes:
measure: Numeric Pain Rating Scale (NRS) (0-10)
timeFrame: 0 - 4 weeks
Secondary outcomes:
measure: Global Health Improvement Score (GROC) (-7 to +7)
timeFrame: 0 - 4 weeks
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Sport & Orthopaedic Physical Therapy
state: Connecticut
Study officials:
affiliation: Walters Sports Medicine Inc
name: Rod Walters, EdD
role: STUDY_DIRECTOR
References:
citation: Draper DO, Wells A, Wilk K. Efficacy of Sustained Acoustic Medicine as an Add-on to Traditional Therapy in Treating Sport-related Injuries : Case Reports. Glob J Orthop Res. 2020;2(4):545. Epub 2020 Sep 21.
citation: Langer MD, Lewis GK Jr. Sustained Acoustic Medicine: A Novel Long Duration Approach to Biomodulation Utilizing Low Intensity Therapeutic Ultrasound. Proc SPIE Int Soc Opt Eng. 2015 May;9467:94670I. doi: 10.1117/12.2178213.
citation: Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.
citation: Winkler SL, Urbisci AE, Best TM. Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. BMC Sports Sci Med Rehabil. 2021 Dec 18;13(1):159. doi: 10.1186/s13102-021-00383-0.