Real-World Experience of Athletes Treated With SAM

NCT04177537 | Completed DMC FDA Device

• 1 other identifier: AL-01
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Low-intensity continuous ultrasound (LICUS) is an FDA-approved bio regenerative technology, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. This report included a retrospective convenience sample of 6 athletes from one sports medicine and rehabilitation facility. The objective of this report is to examine the real-world outcome data on symptoms improvement and return to function using Sam. It was hypothesized that LICUS stimulation, in conjunction with traditional therapies, will accelerate the healing process of musculoskeletal tissue leading to a reduction in pain, increase functionality, and a higher probability of returning to work and sports-related activities. The sample included athletes with sports-related musculoskeletal injuries. Demographics, injury history, treatment history, and clinical outcomes data were retrospectively collected for athletes who were treated with SAM in conjunction with traditional therapies. Clinical results showed a benefit from the treatment with a decrease in pain (100%), and 3 out of 6 athletes were able to return to work or sports (50%). Overall the study shows that Sam accelerates the healing of soft tissue leading to a decrease in both acute and chronic pain.

Conditions

Pain, Chronic; Pain, Acute; Sport Injury; Soft Tissue Injuries; Arm Injury; Back Pain; Tendon Injuries; Muscle Injury

Keywords

low-intensity ultrasound; continuous ultrasound; long-duration ultrasound; athletic training; clinical trial; soft tissue; pain; Musculoskeletal tissue; ZetrOZ System LLC

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. A total of 6 athletes were examined through questionnaires. in which they were asked about the change of pain on the NRS scale. No adverse effects were reported throughout the study.

  variable (1 - 8 weeks)

Other Outcomes (1)

• Return to Work on the scale of number of week

  variable (1 - 8 weeks)

Study Arms (2)

Pre-Low Intensity Continuous Ultrasound Treatment

Retrospective analysis of pain alleviation, range of motion and ability to return to work with traditional therapies selected from one rehabilitation facility

Post-Low Intensity Continuous Ultrasound Treatment

Retrospective analysis 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 selected from one rehabilitation facility

Device: Low Intensity Continuous Ultrasound

Interventions

Low Intensity Continuous Ultrasound DEVICE

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

Post-Low Intensity Continuous Ultrasound Treatment

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Athletes with sport-related musculoskeletal injuries.

You may qualify if:

• Athletes with musculoskeletal injuries with limited improvement under traditional therapies

You may not qualify if:

• Healthy Athletes

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Related Publications (16)

• Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994 Jan;76(1):26-34. doi: 10.2106/00004623-199401000-00004.

  PMID: 8288661 RESULT

• Zhang N, Chow SK, Leung KS, Cheung WH. Ultrasound as a stimulus for musculoskeletal disorders. J Orthop Translat. 2017 Apr 5;9:52-59. doi: 10.1016/j.jot.2017.03.004. eCollection 2017 Apr.

  PMID: 29662799 RESULT

• Best TM, Wilk KE, Moorman CT, Draper DO. Low Intensity Ultrasound for Promoting Soft Tissue Healing: A Systematic Review of the Literature and Medical Technology. Intern Med Rev (Wash D C). 2016 Dec;2(11):271. doi: 10.18103/imr.v2i11.271.

  PMID: 30198009 RESULT

• 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 RESULT

• Lewis GK Jr, Langer MD, Henderson CR Jr, Ortiz R. Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain. Ultrasound Med Biol. 2013 Aug;39(8):1429-39. doi: 10.1016/j.ultrasmedbio.2013.03.007. Epub 2013 Jun 4.

  PMID: 23743101 RESULT

• Rigby JH, Taggart RM, Stratton KL, Lewis GK Jr, Draper DO. Intramuscular Heating Characteristics of Multihour Low-Intensity Therapeutic Ultrasound. J Athl Train. 2015 Nov;50(11):1158-64. doi: 10.4085/1062-6050-50.11.03. Epub 2015 Oct 28.

  PMID: 26509683 RESULT

• Enwemeka CS, Rodriguez O, Mendosa S. The biomechanical effects of low-intensity ultrasound on healing tendons. Ultrasound Med Biol. 1990;16(8):801-7. doi: 10.1016/0301-5629(90)90044-d.

  PMID: 2095010 RESULT

• Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001 Oct;51(4):693-702; discussion 702-3. doi: 10.1097/00005373-200110000-00012.

  PMID: 11586161 RESULT

• Jia XL, Chen WZ, Zhou K, Wang ZB. Effects of low-intensity pulsed ultrasound in repairing injured articular cartilage. Chin J Traumatol. 2005 Jun;8(3):175-8.

  PMID: 15896276 RESULT

• D'Vaz AP, Ostor AJ, Speed CA, Jenner JR, Bradley M, Prevost AT, Hazleman BL. Pulsed low-intensity ultrasound therapy for chronic lateral epicondylitis: a randomized controlled trial. Rheumatology (Oxford). 2006 May;45(5):566-70. doi: 10.1093/rheumatology/kei210. Epub 2005 Nov 22.

  PMID: 16303817 RESULT

• Khanna A, Nelmes RT, Gougoulias N, Maffulli N, Gray J. The effects of LIPUS on soft-tissue healing: a review of literature. Br Med Bull. 2009;89:169-82. doi: 10.1093/bmb/ldn040. Epub 2008 Nov 16.

  PMID: 19011263 RESULT

• Fu SC, Hung LK, Shum WT, Lee YW, Chan LS, Ho G, Chan KM. In vivo low-intensity pulsed ultrasound (LIPUS) following tendon injury promotes repair during granulation but suppresses decorin and biglycan expression during remodeling. J Orthop Sports Phys Ther. 2010 Jul;40(7):422-9. doi: 10.2519/jospt.2010.3254.

  PMID: 20479531 RESULT

• Nagata K, Nakamura T, Fujihara S, Tanaka E. Ultrasound modulates the inflammatory response and promotes muscle regeneration in injured muscles. Ann Biomed Eng. 2013 Jun;41(6):1095-105. doi: 10.1007/s10439-013-0757-y. Epub 2013 Feb 6.

  PMID: 23386031 RESULT

• Draper DO, Ricard MD. Rate of Temperature Decay in Human Muscle Following 3 MHz Ultrasound: The Stretching Window Revealed. J Athl Train. 1995 Oct;30(4):304-7.

  PMID: 16558352 RESULT

• Alexander LD, Gilman DR, Brown DR, Brown JL, Houghton PE. Exposure to low amounts of ultrasound energy does not improve soft tissue shoulder pathology: a systematic review. Phys Ther. 2010 Jan;90(1):14-25. doi: 10.2522/ptj.20080272. Epub 2009 Nov 12.

  PMID: 19910457 RESULT

• Best TM, Moore B, Jarit P, Moorman CT, Lewis GK. Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy. Phys Sportsmed. 2015 Nov;43(4):366-74. doi: 10.1080/00913847.2015.1095617. Epub 2015 Oct 15.

  PMID: 26468991 RESULT

Related Links

• Conference Proceedings Volume 1113, Issue 1, p.403-407
• Conference Proceedings Volume publication date 15 August 2004

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

• David O Draper, EdD

  Brigham Young University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 26, 2019
• Study Start: October 1, 2015
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: November 26, 2019

Record last verified: 2019-11