NCT02609854

Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: ZetrOZ, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

• Chronic Low Back Pain (CLBP)
• Intervertebral Disc Displacement

Interventions

Type	Name	Description
DEVICE	Sustained Acoustic Medicine (SAM)	Long-duration, low-intensity therapeutic ultrasound device that is self-applied and wearable, delivering treatment up to 4 hours per day.
DEVICE	Sham Device	Inactive ultrasound device

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-11-20
• Last updated: 2017-01-31

Locations

3 sites across 1 country: United States