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Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT02609854•ZetrOZ, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (3)

Medical Pain Consultants

Dryden, New York, United States

Osteopathic Medical Arts

Chapel Hill, North Carolina, United States

Weber State University

Ogden, Utah, United States

Key Dates

Start Date

November 1, 2015

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

January 31, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Low Back Pain (CLBP)Intervertebral Disc Displacement

Interventions

Sustained Acoustic Medicine (SAM)

DEVICE

Sham Device

DEVICE

Lumber Stabilization Exercise Versus Back Endurance Exercise Among Female University Students

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RECRUITINGNA

Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training

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RECRUITINGNA

Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Lumber Stabilization Exercise Versus Back Endurance Exercise Among Female University Students

Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training

Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain

Predicting Pain and Disability From Voice Recordings in Low Back Pain

Virtual Reality-Based Rehabilitation in Chronic Low Back Pain: Effects on Muscle Architecture, Balance, and Satisfaction (VR-LBPREHAB)

Electrical Dry Needling Versus Sham Dry Needling in Patients With Chronic Low Back Pain