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

NCT05254470 | Completed FDA Device

• 1 other identifier: CS-02-2021
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Global Health Improvement Score (GROC) (-7 to +7)

  0 - 4 weeks

Study Arms (2)

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.

Device: Continuous Ultrasound

Interventions

Continuous Ultrasound DEVICE

3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device

Post-Low Intensity Continuous Ultrasound Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with work and sport related musculoskeletal injuries

You may qualify if:

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

You may not qualify if:

• Healthy participant

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (1)

Sport & Orthopaedic Physical Therapy

Fairfield, Connecticut, 06824, United States

Location

Related Publications (5)

• 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.

  PMID: 33043316 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.

  PMID: 30078928 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.

  PMID: 33408796 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.

  PMID: 34922606 BACKGROUND

• 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.

  PMID: 36865667 DERIVED

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Soft Tissue Injuries; Arm Injuries; Back Pain; Tendon Injuries; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Rod Walters, EdD

  Walters Sports Medicine Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 24, 2022
• Study Start: September 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

US (1)