Real-World Experience of Athletes Treated With SAM
Condition: Pain, Chronic; Pain, Acute; Sport Injury; Soft Tissue Injuries; Arm Injury; Back Pain; Tendon Injuries; Muscle Injury
MeSH terms: Acute Pain; Chronic Pain; Wounds and Injuries; Athletic Injuries; Tendon Injuries; Soft Tissue Injuries; Arm Injuries
Study type: Observational

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.
    

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.
    

Intervention name(s): Low Intensity Continuous Ultrasound
Intervention type(s): Device
Intervention description(s): 3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Athletes with sport-related musculoskeletal injuries.
      
Keywords: low-intensity ultrasound; continuous ultrasound; long-duration ultrasound; athletic training; clinical trial; soft tissue; pain; Musculoskeletal tissue; ZetrOZ System LLC