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: All patients were selected after multidisciplinary discussion with a specialized pain physician, a psychological and psychiatric evaluation was performed to rule out psychogenic pain as well as other psychiatric morbidity contraindicating an implant. After authorization by the psychologist and psychiatrist an implant was offered.

Inclusion Criteria

* Patients enrolled in this study must meet the following inclusion criteria:
* Patients able to provide informed consent to participate in the study;
* Patient is between the age of 18 and 75;
* Patient has Failed Back Surgery Syndrome;
* Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
* Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
* Patient agrees not to add or increase medication throughout the randomization trial period of the study;
* Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.

Exclusion Criteria

A patient will be excluded from participation in this study if they meet any one of the following criteria:

* Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
* Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
* Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
* Patient currently participating in another clinical study;
* Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
* Patient is not willing to maintain current medication regimen;
* Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
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:

* Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD).
* Primary pain in the lower half of the body.

Exclusion Criteria:

* Requires, or will in the future, diathermy treatments.
* Had implanted spinal cord stimulation system within the last six months.
D: Inclusion Criteria:

1. Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
2. Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
3. Have stable neurological status.
4. Be on a stable analgesic regimen.
5. Be 22 years of age or older at the time of enrollment.
6. Be an appropriate candidate for the surgical procedures required in this study.
7. Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English.
8. Be willing and capable of giving informed consent.
9. Be willing and able to comply with study-related requirements, procedures, and scheduled visits.

Exclusion Criteria:

1. Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
2. Have a BMI ≥ 40.
3. Currently prescribed a daily opioid dosage \> 120 mg morphine equivalents.
4. Have a medical condition or pain in other area(s), not intended to be treated in this study.
5. Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury.
6. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
7. Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
8. Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
9. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
10. Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
11. Have an existing drug pump and/or another active implantable device such as a pacemaker.
12. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guidelines in the Physician's Manual.
13. Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
14. Have a life expectancy of less than one year.
15. Have a local infection at the anticipated surgical entry site or an active systemic infection.
16. Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
17. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
18. Be concomitantly participating in another clinical study.
19. Be involved in an injury claim under current litigation.
20. Be a recipient of Social Security Disability Insurance (SSDI).
21. Have a pending or approved worker's compensation claim.
22. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome.

Answer: B