The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain (TRU-BURST)

Exclusion Criteria

• •1. Subject is not willing to receive implant of a primary cell SCS system.
• •2. Subject is taking more than 50 morphine equivalents of opioid per day.
• •3. Subject has an unstable fusion with FBSS.
• •4. Subject's back and/or leg pain is believed to originate from spinal instability/mechanical pain.
• •5. Subject's back and/or leg pain is believed to originate from existing metal work.
• •6. Subject's low back pain is limited to a single focal pain area that suggests mechanical back pain.
• •7. Subject is currently participating, or intends to participate in another clinical investigation investigating pain management or that could present a confound to this study (per the investigator).
• •8. Subject is pregnant or nursing or subject plans pregnancy during the clinical investigation follow-up period. This includes female who is sexually active and not using a reliable form of birth control or being not surgically sterile or subject is listed as a post-menopausal female within less than 1 year.
• •9. Subject is part of a vulnerable population ( as per section 5.2.2.1 of the study protocol).
• •10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.
• •11. Subject has chronic widespread pain or confounding pain that will interfere with reporting of low back and leg pain (e.g. consider any chronic pain in the upper back, neck, head, face, shoulders, arms, or chronic headaches)
• •12. Subject has previously had permanent implantation of another SCS, DRG stimulation, or intrathecal drug delivery system or is scheduled to receive such system in a timeframe that would overlap with this study.
• •13. Subject has already participated in a SCS trial period before enrolling in the study and is now waiting for their permanent implantation.
• •14. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
• •15. Subject has a skin condition that could be exacerbated by use of the wearable biosensors (e.g., skin allergy to metals, plastics), as determined by the investigator.
• •16. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
• •17. Subject is bedridden.
• •18. Subject has life expectancy of less than 12 months.
• •19. Subject has a current diagnosis of a progressive neurological disorder as determined by the investigator. (e.g. multiple sclerosis, Huntington's disease)
• •20. Subject has a bleeding diathesis such as coagulopathy or thrombocytopenia
• •21. Subject has a current diagnosis of a coagulation disorder or uncontrolled diabetes mellitus.
• •22. Subject is immunocompromised and at an increased risk for infection
• •23. Subject has a systemic infection or local infection
• •24. Subject has regular intake of systemic steroids (except inhaled steroids used to treat asthma)
• •25. BMI \> 40.
• •26. Subject has an active malignant disease or history of cancer requiring treatment in the last 12 months.
• •27. Evidence of an active disruptive psychological or psychiatric disorder or social condition as determined by the investigator.
• •28. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior.
• •29. Subject is involved in an injury claim under active litigation that involves back or leg pain/injury or is receiving or planning to receive worker's compensation payments related to back or leg pain.
• •30. Subject has a diagnosis of spondylolisthesis or scoliosis
• •1\. Urine pregnancy test.