- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177537
Real-World Experience of Athletes Treated With SAM
Efficacy of SAM Sport as an Addon to Traditional Therapy in Treating Sports-related Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The cohort of 6 male athletes (n=6) ages ranged from 18 to 54 years of age, with an average age of 33.5 years with musculoskeletal injuries, which showed little or no improvement with traditional therapies selected from one rehabilitation facility. The group included 3 amateur athletes and 3 professional athletes participated in baseball (2) and golf (1). No healthy athlete was selected, considering the study of nature.
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Athletes with musculoskeletal injuries with limited improvement under traditional therapies
Exclusion Criteria:
- Healthy Athletes
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (NRS) (0-10)
Time Frame: variable (1 - 8 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to Work on the scale of number of week
Time Frame: variable (1 - 8 weeks)
|
Athletes reported response to a questionnaire, implying the return to sporting activity, the lowest number of weeks means quicker recovery and a higher number of weeks meant the lowest recovery
|
variable (1 - 8 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: David O Draper, EdD, Brigham Young University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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