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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Ultrasound | Device | 3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NRS) (0-10) | Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain. | 0 - 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Health Improvement Score (GROC) (-7 to +7) | Quality of health care improvement satisfaction from intervention compared to conservative treatment | 0 - 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with work and sport related musculoskeletal injuries
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| Name | Affiliation | Role |
|---|---|---|
| Rod Walters, EdD | Walters Sports Medicine Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport & Orthopaedic Physical Therapy | Fairfield | Connecticut | 06824 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33043316 | Background | 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. | |
| 30078928 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 23, 2023 | |
| Reset | Feb 15, 2024 |
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| 33408796 | Background | 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. |
| 34922606 | Background | 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. |
| 36865667 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2023 | Feb 15, 2024 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059787 | Acute Pain |
| D017695 | Soft Tissue Injuries |
| D001134 | Arm Injuries |
| D001416 | Back Pain |
| D013708 | Tendon Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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