Clinical trial NCT04177537: Real-World Experience of Athletes Treated With SAM
Official title: Efficacy of SAM Sport as an Addon to Traditional Therapy in Treating Sports-related Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Pain, Acute
Sport Injury
Soft Tissue Injuries
Arm Injury
Back Pain
Tendon Injuries
Muscle Injury
Keywords: low-intensity ultrasound
continuous ultrasound
long-duration ultrasound
athletic training
clinical trial
soft tissue
pain
Musculoskeletal tissue
ZetrOZ System LLC
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes with sport-related musculoskeletal injuries.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Athletes with musculoskeletal injuries with limited improvement under traditional therapies

Exclusion Criteria:

* Healthy Athletes

Primary outcomes:
measure: Numeric Pain Rating Scale (NRS) (0-10)
timeFrame: variable (1 - 8 weeks)
Secondary outcomes:
Other outcomes:
measure: Return to Work on the scale of number of week
timeFrame: variable (1 - 8 weeks)
Locations:
Study officials:
affiliation: Brigham Young University
name: David O Draper, EdD
role: STUDY_CHAIR
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