E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain

Exclusion Criteria

• •Subjects that have a demand type pacemaker or defibrillator.
• •Subjects that have had previous experience with electrotherapy.
• •Subjects that have had any failed back surgeries.
• •Subjects that have spinal stenosis which contributes to, or is the cause of lower back pain.
• •Subjects that have sciatica (lower back pain with radicular symptoms).
• •Subjects that have cauda equina syndrome.
• •Subjects that have fibromyalgia.
• •Subjects that have pain secondary to cancer.
• •Subjects who have cancer in the same anatomical location as their back pain.
• •Subjects that have any sensory deprivation or diagnosis of shingles or post- herpetic neuralgia (specifically in the mid-trunk region).
• •Subjects that have planned surgeries during the study period.
• •Subjects that have a history of alcohol or substance abuse in the last 5 years.
• •Subjects on psychoactive medication(s) that:
• •1. have had a change in dose or a change in medication type during the 3 months prior to screening, or
• •2. are expected to require a change in dose, or a new medication during the study.
• •Subjects that are seeking worker's compensation or any other legal claims.
• •Subjects that are pregnant or plan to become pregnant during the study period.