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
15 participants
OBSERVATIONAL
2015-10-01
2015-10-31
Brief Summary
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Detailed Description
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Demographic, injury history, treatment history, and clinical outcomes data of the patients were collected. The patients were asked about the effectiveness of traditional therapies such as physical therapy, manual therapy, a combination of rest, ice, compression, and elevation (RICE). The athletes with sports-related musculoskeletal related injuries, including arm, upper leg, back, quadriceps, knees, foot/ankles, were treated with low-intensity continuous ultrasound (SAM®, ZetrOZ Sysmtem LLC device) in conjunction with traditional therapies. At that point, data were recorded, and patients were advised to use LICUS in conjunction with conventional therapies. The athletes were asked about the effectiveness of LICUS treatment as an add-on to traditional therapies. Furthermore, .the effectiveness of the treatment was assessed by patient response to pain relief, range of motion, and ability to going back to the sport.
The LICUS was delivered by easy to use wearable LICUS device (SAM®, ZetrOZ Systems, LLC, Trumbull, CT) consisting of two transducers powered by an external battery pack was used to deliver at 3MHz, 0.132W/cm2, 1.3W for 4 hours. The athletes were trained to use the device using ultrasound coupling gel on the injured area. It was ensured that all the athletes knew how to use the device properly. The device is easy to use with three buttons setup: an on/off button (middle), a time, and on/off lock buttons on the sides.
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
Retrospective analysis of pain alleviation, range of motion and ability to return to work with traditional therapies selected from one rehabilitation facility
No interventions assigned to this group
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
Low Intensity Continuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC
Interventions
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Low Intensity Continuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
54 Years
ALL
No
Sponsors
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ZetrOZ, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David O Draper, EdD
Role: STUDY_CHAIR
Brigham Young University
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Conference Proceedings Volume 1113, Issue 1, p.403-407
Conference Proceedings Volume publication date 15 August 2004
Other Identifiers
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AL-01
Identifier Type: -
Identifier Source: org_study_id
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