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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: ZetrOZ, Inc.

Current Primary Outcome: Brief Pain Inventory-Short Form (BPI-SF): Pain Severity [ Time Frame: Change from Baseline to Week 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • BPI-SF: Pain Interference [ Time Frame: Change from Baseline to Week 8 ]
  • Oswestry Disability Index [ Time Frame: Change from Baseline to Week 8 ]
  • Numeric Rating Scale: Pain on Flexion [ Time Frame: Change from Baseline to Week 8 ]
  • Numeric Rating Scale: Pain on Extension [ Time Frame: Change from Baseline to Week 8 ]


Original Secondary Outcome:

  • BPI-SF: Pain Interference [ Time Frame: Change from Baseline to Week 8 ]
  • Oswestry Disability Index [ Time Frame: Change from Baseline to Week 8 ]
  • ActiGraph Activity Monitor [ Time Frame: Change from Baseline to Week 8 ]
  • Numeric Rating Scale: Pain on Flexion [ Time Frame: Change from Baseline to Week 8 ]
  • Numeric Rating Scale: Pain on Extension [ Time Frame: Change from Baseline to Week 8 ]


Information By: ZetrOZ, Inc.

Dates:
Date Received: November 17, 2015
Date Started: November 2015
Date Completion:
Last Updated: January 29, 2017
Last Verified: January 2017