Back Pain Clinical Trial
Official title:
Efficacy of SAM Sport as an Addon to Traditional Therapy in Treating Sports-related Injuries
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.
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.
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