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

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