Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
NCT ID: NCT05254470
Last Updated: 2022-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
2020-09-01
2022-02-01
Brief Summary
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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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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Pre-Low Intensity Continuous Ultrasound Treatment
Routine care for pain alleviation, range of motion and ability to return to work with traditional therapies from rehabilitation.
No interventions assigned to this group
Post-Low Intensity Continuous Ultrasound Treatment
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.
Continuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device
Interventions
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Continuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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ZetrOZ, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rod Walters, EdD
Role: STUDY_DIRECTOR
Walters Sports Medicine Inc
Locations
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Sport & Orthopaedic Physical Therapy
Fairfield, Connecticut, United States
Countries
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References
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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.
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.
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.
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.
Jarit P, Klyve D, Walters R. Long Duration Sonophoresis of Diclofenac to Augment Rehabilitation of Common Musculoskeletal Injuries. Glob J Orthop Res. 2023;4(2):584. Epub 2023 Jan 20.
Other Identifiers
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CS-02-2021
Identifier Type: -
Identifier Source: org_study_id
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