CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Low Intensity Continuous Ultrasounddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04177537
NCT04177537N/ACompleted

Efficacy of SAM Sport as an Addon to Traditional Therapy in Treating Sports-related Injuries

ZetrOZ, Inc.·observational·Posted Nov 26, 2019·Updated Nov 26, 2019

In Brief

An observational study evaluating Low Intensity Continuous Ultrasound for Pain, Chronic and 7 related conditions. Completed, enrolled 15 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 26, 2019
Enrollment StartOct 1, 2015
Primary CompletionOct 31, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.6 years ago

Interventions

Low Intensity Continuous Ultrasounddevice

3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC