Enso Pilot Study for Chronic Low Back Pain

Exclusion Criteria

• •1. Patients that do not own or have access to a smartphone
• •2. Subject who, in the Investigator's opinion, does not demonstrate a strong desire to reduce opioid or other pain medication usage (e.g., opioid dependence)
• •3. Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
• •4. Primary symptoms due to spinal stenosis
• •5. Source of back pain related to an acute nerve impingement
• •6. Diagnosis of cancer/malignant tumors in the last 5 years
• •7. Source of back pain is an infection
• •8. Prior spinal fusion surgery
• •9. Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
• •10. Has radicular pain symptoms that account for more than 20% of their pain and/or functional impairment
• •11. Has undergone surgery to solve pain related to the study indication in the past 6 months
• •12. Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
• •13. Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in the judgement of the investigator.
• •14. Inability to complete subjective data as required; e.g. on mobile application and questionnaires
• •15. Pregnant women (as determined by self-report)
• •16. Have severe epilepsy
• •17. Have severe form of cardiovascular disease
• •18. Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes