A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain

Inclusion Criteria:

- active duty Service Members (SMs) between the ages of 18 and 62, inclusive

- history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3
months or greater prior to entry into the study

- participants must be using narcotic and/or non-narcotic oral analgesic medications to
treat their chronic LBP symptoms on a weekly basis

- must be able to speak and read English and understand the study procedures

Exclusion Criteria:

- pacemaker or implanted electronic device

- history of stroke, blood clots, or cardiac arrhythmias

- pregnancy

- no self-reported history of prescription medication abuse or sole-provider contract
for prescribed narcotic medications

- open wound over site of chronic pain;

- history of spinal surgery

- participation in a clinical trial for an investigational drug/ treatment within last
30 days

- undergone treatment with TENS, biofeedback, or acupuncture within last 30 days

- prior treatment with the Biomodulator

- LBP "red flags": fever, trauma, progressive motor or sensory deficit, saddle
anesthesia

- participation in the study would delay the medical board (MEB) processing of the
service member off of active duty status or would delay a return to duty status to
their home unit