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NCT02609854 · ClinicalTrials.gov registry record · NA
Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions
A NA study of Chronic Low Back Pain (CLBP) and Intervertebral Disc Displacement, sponsored by ZetrOZ.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 3
- Study locations
NCT02609854 is a NA study of Chronic Low Back Pain (CLBP) and Intervertebral Disc Displacement that has completed, run by ZetrOZ. The registered enrollment target is 65 participants, below the 193-participant average among 8 other Chronic Low Back Pain (CLBP) trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT02609854, a NA study of Chronic Low Back Pain (CLBP) and Intervertebral Disc Displacement, has completed, sponsored by ZetrOZ.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 3
- Study locations
Study Summary
ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with chronic low back pain, a subset of which will have chronic low back pain due to a herniated disc, over an 8-week treatment period.
Conditions Studied
Interventions
- DEVICE Sham Device
- DEVICE Sustained Acoustic Medicine (SAM)
Study Locations (3)
New York
- Medical Pain Consultants - Dryden
North Carolina
- Osteopathic Medical Arts - Chapel Hill
Utah
- Weber State University - Ogden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02609854
The ClinicalTrials.gov registry entry for NCT02609854 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 8 other Chronic Low Back Pain (CLBP) trials with a reported enrollment target (66% lower). The listed sponsor is ZetrOZ, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Low Back Pain (CLBP) appearing as the primary indexed condition, and to 2 interventions - of which Sham Device is the first listed.
NCT02609854 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New York, North Carolina, Utah.
Frequently Asked Questions
What is clinical trial NCT02609854 about?
NCT02609854 is a clinical study titled "Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions". ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint...
What is the current status of trial NCT02609854?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2015-11. Estimated completion is 2016-04.
What conditions does trial NCT02609854 study?
This clinical trial studies the following conditions: Chronic Low Back Pain (CLBP), Intervertebral Disc Displacement.
What interventions are being tested in trial NCT02609854?
The interventions under investigation include: Sham Device (DEVICE), Sustained Acoustic Medicine (SAM) (DEVICE).
Who is sponsoring clinical trial NCT02609854?
This trial is sponsored by ZetrOZ, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02609854 being conducted?
This trial has 3 study locations across New York, North Carolina, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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