Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial
Brief Summary: The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).


Options:
A: Key Inclusion Criteria:

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
3. Qualifying pain score
4. Be on stable pain medications, as determined by the Investigator
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
7. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent

Key Exclusion Criteria:

1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
5. Have any addictions as determined by the Investigator
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have prior experience with neuromodulation devices
8. Other general exclusions applicable for SCS devices
9. Be involved in an injury claim under current litigation
10. Have a pending or approved worker's compensation claim
B: Inclusion Criteria:

1. Occurrence of chronic pain in the lumbosacral region, as well as unilateral or bilateral leg pain.
2. Prior lumbar surgery in medical history.
3. Diagnosed with neuropathic pain in the lower extremities and graded as probable neuropathic pain or definite neuropathic pain according International Association for the Study of Pain (IASP) criteria.
4. Patient report largely unchanged pain condition last 6 months.
5. Patient has undergone a 7 day SCS trial with epidural burst stimulation with the following results:

   1. At least 75% coverage of the painful area of tonic stimulation before start of burst trial stimulation.
   2. At least 50% reduction in pain intensity, measured via BPI, item 5 from baseline of trial to end of trial period.
6. The patient is ≥ 18 years of age and \< 60 years of age.
7. The patient must willingly participate in all parts of the study, as well as having the ability to complete the entire study plan.
8. Patient must certify that he / she understands the study plan, as well as voluntarily sign informed consent to participate in the study.
9. Must be able to sit still for a minimum of 45 minutes and be able to follow restrictions related to the PET survey.

Exclusion Criteria:

1. The patient has other current pain conditions than back and leg pain after back surgery.
2. The patient is treated with opioids exceeding 80 milligrams of Morphine per day or is considered at risk for development of problematic opioid use.
3. The patient suffers from an untreated depression or anxiety.
4. The patient can not complete the study plan.
5. The patient is unable to read or write Swedish.
6. The patient is currently participates in another clinical trial.
7. A history of previous PET scan or other substantial radiation dose in the last 5 years.
8. The patients is suffering from claustrophobia.
9. Ongoing pregnancy or planned pregnancy during study time.
10. The patient has contraindications for arterial catheterization.
11. The patient is previously treated with spinal cord stimulation.
C: Inclusion Criteria:

* Chinese outpatient of age 18 to 75
* At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ

Exclusion Criteria:

* Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
* Serum creatinine clearance greater than 60 ml/min
D: Inclusion Criteria:

1. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
2. Age ≥ 18 years
3. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
4. Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care
5. Patient has not had spine surgery for back or leg pain
6. Patient is a candidate for spinal cord stimulation
7. Low back pain ≥ 6 on Numerical Rating Scale
8. Oswestry Disability Index score of ≥ 30%
9. Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan

Exclusion Criteria:

1. Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
2. Primary complaint of leg pain, or leg pain is greater than back pain
3. Back pain is due to any of the following:

   * spinal instability defined as \> 2 mm translation on radiographic imaging
   * visceral causes (e.g., endometriosis or fibroids)
   * vascular causes (e.g., aortic aneurysm)
   * spinal infection (e.g., osteomyelitis)
   * inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)
   * tumor or spinal metastases
4. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)
5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
6. Neurological deficit (e.g. foot drop)
7. Prior lumbar spine surgery or sacroiliac joint fusion
8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days
9. Patient is bed bound
10. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement
12. Known allergic reaction to implanted materials
13. Severe scoliotic deformity (\>11 degrees in thoracic or lumbar spine)
14. Patient has a history of, or existing intrathecal drug pump
15. Patient has previous experience with neuromodulation devices, including a failed trial
16. BMI \> 40
17. Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel
18. 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 results.
19. Failed psychological evaluation
20. Suspicion or evidence of untreated mental illness, or substance abuse
21. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior
22. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
23. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

    * Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

Answer: B