Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04177537
Other study ID # AL-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2015
Est. completion date October 31, 2015

Study information

Verified date November 2019
Source ZetrOZ, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Intervention

Device:
Low Intensity Continuous Ultrasound
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ZetrOZ, Inc.

References & Publications (16)

See more »

Outcome

Type Measure Description Time frame Safety issue
Other Return to Work on the scale of number of week Athletes reported response to a questionnaire, implying the return to sporting activity, the lowest number of weeks means quicker recovery and a higher number of weeks meant the lowest recovery variable (1 - 8 weeks)
Primary Numeric Pain Rating Scale (NRS) (0-10) Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain. A total of 6 athletes were examined through questionnaires. in which they were asked about the change of pain on the NRS scale. No adverse effects were reported throughout the study. variable (1 - 8 weeks)
See also
  Status Clinical Trial Phase
Completed NCT05982483 - Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain N/A
Completed NCT04744246 - Muscle Activity During Load Carriage in ROTC Cadets N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Active, not recruiting NCT03680846 - Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain N/A
Completed NCT05597189 - Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain N/A
Completed NCT05342181 - Static and Dynamic Core Stability Exercises in Potpartum Back Pain N/A
Completed NCT02955342 - Back and Neck Pain in Adolescence
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Not yet recruiting NCT02536274 - "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" N/A
Recruiting NCT02237105 - The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Terminated NCT02239627 - Epidural Clonidine Versus Corticosteroid for Low Back Pain N/A
Completed NCT02254694 - The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body N/A
Completed NCT00986180 - NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain Phase 3
Completed NCT00771758 - Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Phase 3
Terminated NCT00769626 - Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy Phase 3
Withdrawn NCT00231374 - Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning N/A
Completed NCT00454064 - Cognitive-behavioural Treatment of Chronic Back Pain Phase 3
Completed NCT00103675 - Sensor Measurement of Acupuncture Needle Manipulation Phase 1