Clinical Studies & Abstracts

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sam® daily multi-hour low intensity ultrasound treatment can reduce the use of narcotics, treat arthritis pain and accelerate the natural healing cascade of tissue injuries

Daily sam® treatment reduced arthritis pain by 40% in patients with moderate to sever knee OA.

Journal of Orthopedic Research and Surgery

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Daily sam® treatment healed chronic tendinopathy and reduced tendon pain by 90%

The Physician and Sportsmedicine

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Meta-analysis on sam® for soft tissue healing and increasing collagen matrix production

Internal Medicine Review 

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sam® CLINICAL RESEARCH SUMMARY

  • sam® 2.0 is the only FDA-cleared long duration ultrasound device for prescription home-use to reduce pain, increase local circulation and reduce joint stiffness/contracture. sam® utilizes multi-hour ultrasound to generate deep diathermy in tissue and is clinically proven to reduce chronic joint and back pain in multiple clinical trials. As outlined below, recent meta-analysis of the literature demonstrates the unique ultrasound treatment algorithm delivered by sam® is safe, effective and a clinically valid treatment option for Joint Arthritis, and Upper Neck, Shoulder and Back pain, and the Treatment of Soft-Tissue Injuries.
  • Joint Arthritis Pain Treatment with sam®: In a clinical research study on sam® long duration continuous ultrasound treatment for knee osteoarthritis, patients experienced a 52% pain reduction and 20% improvement in joint function, which were statistically significant (p<0.05). (Langer, 2014). In another placebo-controlled study on arthritis pain, sam® long duration continuous ultrasound treatment reduced joint pain by 2.5 points (48%) over six weeks of treatment which was statistically significant over the placebo 1.23 point decrease (p<0.03). (Langer, 2015).  In a third double-blind placebo controlled clinical study on sam® for joint arthritis pain, patients had significant 1.96 point (40%) pain reduction for active (p<0.0001) vs. 0.85 point reduction for placebo treatment (p<0.13). Active sam® treatment patients also had significant improvement in pain, stiffness and function on the Western Ontario and McMaster Universities (WOMAC) scale compared with placebo (500 vs. 311 respectively, p<0.02). Rotational strength of the treated knee was increased by 3.2N, p=0.03) in the active treatment group. (Draper, 2018). A recent 2019 systematic review and meta-analysis on therapeutic ultrasound diathermy for knee osteoarthritis included 15 studies. The results demonstrated that therapeutic ultrasound significantly relieved pain (p<0.00001) and reduced the Western Ontario and McMaster Universities (WOMAC) physical function score (p=0.03). In addition, therapeutic ultrasound increased the active range of motion (p<0.00001) and reduced the Lequesne index (p<0.00001). The authors concluded that therapeutic ultrasound is a safe treatment to relieve pain and improve physical function in patients with knee osteoarthritis. (Wu, 2019).
  • Upper Back, Neck and Shoulder Pain Treatment with sam®: In a double-blind placebo controlled clinical trial of a self-applied sam® long duration ultrasound device was compared to placebo for trapezius myofascial pain over 10 treatment sessions. Active sam® treatment demonstrated a significant 190% reduction in pain and 158% improvement in health compared to placebo after only 1-hour of treatment (p<0.05) (Lewis, 2013). An additional double-blind placebo controlled study on sam® for trapezius myofascial pain was completed. Patients treated with active therapy observed a significant mean pain reduction from baseline of 2.61-points for active (p<0.001), compared to 1.58-points reduction from baseline for placebo (p=0.087), resulting in a significant 1.03-point greater decrease in active over placebo (p=0.003). Overall health quality score was significantly higher in the active group at 2.84 points compared to the placebo group at 0.46 points (p<0.001). (Patterson, 2020). Two recent 60 and 54 subject placebo-controlled studies on therapeutic ultrasound diathermy for trapezius myofascial pain demonstrated significant reduction in pain for active continuous ultrasound, respectively. The authors concluded that therapeutic ultrasound is an effective treatment of myofascial pain syndrome, and continuous therapy is the most effective. (Ilter, 2015), (Yildirim, 2018). A systematic review and meta-analysis (1966-2016) on therapeutic ultrasound including 10 studies and 428 subjects demonstrated that therapeutic ultrasound significantly reduced pain intensity and increased pain threshold. (Xia, 2017).

CLINICAL LEVEL 1 EVIDENCE

  1. Draper, David O., and Thomas Best 2021. “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.
  2. Madzia et al 2020 “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: 176.
  3. Patterson et al 2020 “Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial” J Pain Res. 2020; 13: 1899.
  4. Best et al 2020 “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, 2020, 15, 481
  5. Draper et al 2018 “Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee 1 osteoarthritis: a randomized, placebo-controlled double-blind study” J Orthop Surg Res. 2018; 13: 257.
  6. Daniels et al 2018 “The Effects of Low-Intensity Therapeutic Ultrasound on Measurable Outcomes: A Critically Appraised Topic” Journal of Sport Rehabilitation, 2018, 27, 390-395
  7. Mattern et al 2017 “The Effect of Low Intensity Wearable Ultrasound on Blood Lactate and Muscle Performance after High Intensity Resistance Exercise” JEP Online August 2017 Vol 20 No
  8. Draper et al 2016 “Low Intensity Ultrasound for Promoting Soft Tissue Healing: A Systematic Review of the Literature and Medical Technology” Intern Med Rev (Wash D C)
  9. Rigby et al 2015 “Intramuscular Heating Characteristics of Multihour Low-Intensity Therapeutic Ultrasound” Journal of Athletic Training 2015;50(11):000–000
  10. Lewis et al 2013 “Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain.” Ultrasound Med Biol. 2013 Aug;39(8):1429-39

CLINICAL LEVEL 4 EVIDENCE

  1. Draper et al 2020 “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.
  2. Masterson et al 2020 “Sustained acoustic medicine; sonophoresis for nonsteroidal anti-inflammatory drug delivery in arthritis” Journal of Therapeutic Delivery 13; 2020:
  3. Draper, David, and Rajiv M. Mallipudi. “Therapeutic ultrasound: myths and truths for non-portable in-clinic and portable home use ultrasound.” MOJ sports mo https://www.ncbiedicine 4.4 (2020): 115.
  4. Best et al 2015 “Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy” The Physician and Sportsmedicine 15 Oct 2015.
  5. Langer et al 2014 “Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis” Proc IEEE Annu Northeast Bioeng Conf. 2014 April ; 2014:
  6. Taggart et al 2014 “Human Factors Engineering and Testing for a Wearable, Long Duration Ultrasound System Self-Applied by an End User” Conf Proc IEEE Eng Med Biol Soc. 2014 ; 2014: 554–557.
  7. Lewis et al 2013 “Wearable long duration ultrasound therapy pilot study in rotator cuff tendinopathy” Proc Meeting of Acous. June 2013.

CLINICAL LEVEL 5 EVIDENCE & DOCUMENTS

  1. 2020 National Institutes of Health Pain Symposium SAM Feature
  2. 2018 NIH News article on sam® for knee arthritis pain
  3. sam® Sport health economics on back pain (company whitepaper)
  4. Lewis et al 2016 “sam® Sport for the Non-Surgical Soft-Tissue Treatment of Athletes”
  5. Lewis et al 2015 “Review of sam® literature supporting efficacy”
  6. Langer et al 2015 “Sustained Acoustic Medicine A Novel Long Duration Approach” Proc SPIE 2015
  7. Langer et al 2013 “Long duration low intensity ultrasound increases NSAID delivery over four hours” Poc ACOUS 2013

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HEALING SOFT TISSUE INJURIES