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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02609854
First Posted: November 20, 2015
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ZetrOZ, Inc.
  Purpose
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.

Condition Intervention
Chronic Low Back Pain (CLBP) Intervertebral Disc Displacement Device: Sustained Acoustic Medicine (SAM) Device: Sham Device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions

Resource links provided by NLM:


Further study details as provided by ZetrOZ, Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 65
Study Start Date: November 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609854


Locations
United States, New York
Medical Pain Consultants
Dryden, New York, United States, 13053
United States, North Carolina
Osteopathic Medical Arts
Chapel Hill, North Carolina, United States, 27514
United States, Utah
Weber State University
Ogden, Utah, United States, 84408
Sponsors and Collaborators
ZetrOZ, Inc.
  More Information

Responsible Party: ZetrOZ, Inc.
ClinicalTrials.gov Identifier: NCT02609854     History of Changes
Other Study ID Numbers: BP-01
First Submitted: November 17, 2015
First Posted: November 20, 2015
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by ZetrOZ, Inc.:
herniated disc
sustained acoustic medicine
ultrasound
CLBP

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disc Displacement
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical