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 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.

Study Overview

• Status: Completed
• Conditions: Intervertebral Disc Displacement; Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Device: Sham Device; Device: Sustained Acoustic Medicine (SAM)

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Dryden, New York, United States, 13053
      • Medical Pain Consultants
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Osteopathic Medical Arts
  • Utah
    • Ogden, Utah, United States, 84408
      • Weber State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Chronic low back pain, may be secondary to herniated nucleus pulposus (HNP) or other causes
• 18-60 years of age, inclusive
• Has Numeric Rating Scale (NRS) pain severity score of at least 4 for a minimum 5 days over the 1 week Baseline Period prior to being randomized to treatment
• Pain lasting >3 months
• Has MRI from within 2 months prior to Screening (If no recent MRI is available, then subject must agree to have MRI performed prior to randomization of treatment)
• If pain is secondary to HNP: MRI within the last 2 months demonstrating the presence of a herniated disc; herniated disc is laterally located and not centrally located; herniated disc is not sequestered
• Has the presence of radicular pain as assessed by a health care practitioner
• Is willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
• Is maintained on a stable pain management regimen, which may include opioid and/or non-opioid analgesic medications, but must be willing to keep dosage(s) stable through the study period; any dose adjustments that the investigator feels are required during the study period must be discussed with the study sponsor; and the use of any medications must be documented in the subject's Medication Log.
• Be willing to discontinue any other interventional treatment modalities on the lower back during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Exclusion Criteria:

• Cannot successfully demonstrate the ability to put on and take off the device.
• Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
• Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
• Has arthritis, bone spurs, stenosis, fusions, or implants near the treatment area.
• Is pregnant.
• Is a prisoner.
• Is non-ambulatory (unable to walk).
• Has a pacemaker.
• Has a malignancy in the treatment area.
• Has an active infection, open sores, or wounds in the treatment area.
• Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
• Has a known neuropathy (disease of the brain or spinal nerves).
• Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
• Has peripheral artery disease.
• Has BMI ≥30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham Sustained Acoustic Medicine Device; Sham Sustained Acoustic Medicine device - the device is to be used 4 hours/day, ≥4 days per week for 8 weeks.	Device: Sham Device; Inactive ultrasound device
Experimental: 3 MHz Sustained Acoustic Medicine Device; 3 MHz Sustained Acoustic Medicine device - the device is to be used 4 hours/day, ≥4 days per week for 8 weeks.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ZetrOZ, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 29, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: ultrasound; CLBP; herniated disc; sustained acoustic medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement
• Other Study ID Numbers: BP-01