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Therm-X Studies

 
 
 
 
 

 

sam® Studies

SAM is a long-duration ultrasound treatment that biophysically activates cellular and transport kinetic activity to amplify the bodies healing response over a period of 4-8 weeks. Since the device is wearable and home-use; the patient can receive a multi-hour healing enhancement daily, which is the primary reason SAM has proven so clinically effective (duration and regularity of treatment). The medical device operates at an ultrasonic frequency/intensity/output that has been closely optimized to therapeutically maximize dose-response to the musculoskeletal system. Recommended use of the treatment is 4 hrs per day 5-7 days per week to achieve the clinical outcomes/results below:

Peer Reviewed Prospective Clinical Trials and Outcomes on SAM Treatment (arranged by date)

  • Madzia, Alex, et al. "Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study." The open orthopaedics journal 14 (2020): 176.
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7784557/
    • Measurable Outcomes/Results (Pain & Function): Patients with moderate to severe knee arthritis pain have a significant 2-3 point pain reduction (50-70%) from baseline, and significant 350-510 point improvement in joint function.
  • Petterson, Stephanie, et al. "Low-intensity continuous ultrasound for the symptomatic treatment of upper shoulder and neck pain: A randomized, double-blind placebo-controlled clinical trial." Journal of Pain Research 13 (2020): 1277.
  • Draper, David O., et al. "Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study." Journal of orthopaedic surgery and research 13.1 (2018): 1-9.
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192104/
    • Measurable Outcomes/Results (Pain and Function): Patients with moderate to sever knee arthritis pain observed a significant 2 point pain reduction and a significant 505 point improvement in joint function with SAM treatment.
  • Langer, Matthew D., et al. "The Effect of Low Intensity Wearable Ultrasound on Blood Lactate and Muscle Performance after High Intensity Resistance Exercise." Journal of Exercise Physiology Online 20.4 (2017).
  • Best, Thomas M., et al. "Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy." The Physician and sportsmedicine 43.4 (2015): 366-374.
    • https://pubmed.ncbi.nlm.nih.gov/26468991/
    • Measurable Outcomes/Results (Pain, Function and Strength). Patients demonstrated a significant 3.9 point reduction in pain, a significant 2.83kg improvement in strength and function with SAM treatment of tendinopathy.
  • Rigby, Justin H., et al. "Intramuscular heating characteristics of multihour low-intensity therapeutic ultrasound." Journal of athletic training 50.11 (2015): 1158-1164.
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732395/
    • Measurable Outcomes/Results (Diathermy): SAM treatment provides a mild IM temperature increase of 1°C for the first 10 minutes into the treatment, and a more vigorous temperature increase of 4°C  80  minutes into the treatment and sustained thereafter. SAM provides tissue heating equivalent to traditional ultrasound but can be sustained for multiple hours.
  • Langer, Matthew D., et al. "Pilot clinical studies of long duration, low intensity therapeutic ultrasound for osteoarthritis." 2014 40th Annual Northeast Bioengineering Conference (NEBEC). IEEE, 2014.
  • Taggart, Rebecca, Matthew D. Langer, and George K. Lewis. "Human Factors Engineering and testing for a wearable, long duration ultrasound system self-applied by an end user." 2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 2014.
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4361019/
    • Measurable Outcomes/Result (Usability and Function): Nearly all patients were able to successfully operate the SAM device (95%) and thought the device was easy to use (93%). Additionally, 90% of users had a positive experience overall, and 87% of users would use the SAM device again.
  • Lewis, George, et al. "Wearable long duration ultrasound therapy pilot study in rotator cuff tendinopathy." Proceedings of Meetings on Acoustics ICA2013. Vol. 19. No. 1. Acoustical Society of America, 2013.
  • Lewis Jr, George K., et al. "Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain." Ultrasound in medicine & biology 39.8 (2013): 1429-1439.
    • https://pubmed.ncbi.nlm.nih.gov/23743101/
    • Measurable Outcomes/Results (Pain and Health Improvement): Patients showed a significant1.94x reduction in pain and a significant 1.58x improvement in health quality with the use of SAM treatment for myofascial pain.

 

Peer Reviewed Health Economic and Metanalysis Studies (arranged by date)

  • Best, Thomas, et al."Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management." Journal of orthopaedic surgery and research 15.1 (2020): 1-10.
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7574225/
    • Measurable Outcomes/Results (Pain, Function and Cost-Effectiveness): Patients treated with SAM have superior pain reduction and improvement in function compared with physical therapy alone. Incremental cost-effectiveness demonstrated that most of the time (84%) SAM treatment resulted in improved functional effectiveness at a slightly higher cost without the need for injections, therapeutics or surgery.

 

Peer Reviewed Real-World Outcomes Studies (arranged by date)

  • Draper, David, et al. "Efficacy of Sustained Acoustic Medicine as an Add-on to Traditional Therapy in Treating Sport-related Injuries." Global journal of orthopedics research 2.4 (2020).
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544191/
    • Measurable Outcomes/Results (Pain and Return to Activity): Patients treated has a significant 3 point reduction in pain, and 55% of patients were able to heal the injury and return back to work after conservative treatment had failed.
  • Draper, David "Effect of Sustained Acoustic Medicine on Bruising Following A Bicycle Crash." Archives of orthopedics and rheumatology 3.2 (2020): 15.

 

Peer Reviewed Technology Assessments, Review Articles and Society Support (arranged by date)

  • Draper, David O., and Thomas Best. "Critical survey and panel review of sustained acoustic medicine in the treatment of sports-related musculoskeletal injuries by professional sports athletic trainers." Current Orthopaedic Practice (2021).
  • Draper, David, and Rajiv M. Mallipudi. "Therapeutic ultrasound: myths and truths for non-portable in-clinic and portable home use ultrasound." MOJ sports medicine 4.4 (2020): 115.
    • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802764/
    • Measurable Outcomes/Results (Technology Assessment): The benefits of SAM over other non-portable ultrasound devices is the capability of delivering daily ultrasound at home or in the office for up to 4 hours at a time. Traditional ultrasound is applied for 5–15 mins delivering between 2,000–5,000 Joules. The 4 hour sam® treatment can produce nearly 4 times as much (18,000 joules) as traditional ultrasound. The portable SAM device can be used at home at any time of the day and during any activity; however, traditional ultrasound requires application by a therapist in the clinical facility.
  • Daniels, Sarah, et al. "The effects of low-intensity therapeutic ultrasound on measurable outcomes: a critically appraised topic." Journal of sport rehabilitation 27.4 (2018): 390-395.
    • https://journals.humankinetics.com/view/journals/jsr/27/4/article-p390.xml
    • Measurable Outcomes/Results (Literature Review): Studies show that SAM can deliver low-intensity acoustic energy over a prolonged period (hours), as well as medium-intensity treatments over a shorter period (minutes), achieving the same temperature increase and pain relief that come from traditional US units, in a more versatile and patient-friendly manner.
  • Best, Thomas M., et al. "Low intensity ultrasound for promoting soft tissue healing: a systematic review of the literature and medical technology." Internal medicine review (Washington, DC: Online) 2.11 (2016).
  • Langer, Matthew D., and George K. Lewis Jr. "Sustained acoustic medicine: a novel long duration approach to biomodulation utilizing low intensity therapeutic ultrasound." Micro-and Nanotechnology Sensors, Systems, and Applications VII. Vol. 9467. International Society for Optics and Photonics, 2015.
    • https://pubmed.ncbi.nlm.nih.gov/30078928/
    • Measurable Outcomes/Results (Technology Assessment): Therapeutic ultrasound is an established technique for biomodulation used by physical therapists. Typically, it is used to deliver energy locally for the purpose of altering tissue plasticity and increasing local circulation. Ultrasound miniaturization in SAM allows for portable, wearable, self-applied ultrasound devices that sidestep these limitations. Additionally, research has shown that the timescale of acoustic stimulation matters, and directly affects the quality of result. This paper describes a novel, long duration approach to therapeutic ultrasound and reviews the current data available for a variety of musculoskeletal conditions.
  • ZetrOZ Systems CE/FDA Literature Review for Mechanisms of Action, Company Document 2014.