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

Back Pain Clinical Trial

Official title:

Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254470
• Other study ID #: CS-02-2021
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2022
• Source: ZetrOZ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Healthy participant

Related Conditions & MeSH terms

• Acute Pain
• Arm Injuries
• Arm Injury
• Athletic Injuries
• Back Pain
• Chronic Pain
• Muscle Injury
• Musculoskeletal Injury
• Pain, Acute
• Pain, Chronic
• Soft Tissue Injuries
• Sport Injury
• Tendon Injuries
• Wounds and Injuries

Intervention

Device:
• Continuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device

Locations

Country	Name	City	State
United States	Sport & Orthopaedic Physical Therapy	Fairfield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ZetrOZ, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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). pii: 545. Epub 2020 Sep 21. — View 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. pii: 94670I. doi: 10.1117/12.2178213. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Global Health Improvement Score (GROC) (-7 to +7)	Quality of health care improvement satisfaction from intervention compared to conservative treatment	0 - 4 weeks