Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
Brief Summary: Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.


Options:
A: Key Inclusion Criteria:

* Chronic low back pain, with or without leg pain, for at least 6 months
* Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
* Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
* Require implantation of lead(s) in the cervical epidural space
* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
* Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
B: Inclusion Criteria:

* Men or women with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome and intractable low back and leg pain, and for whom Burst-SCS has been recommended as a treatment option
* Candidates who can speak, read, and understand English

Exclusion Criteria:

* Subjects who are pregnant- as determined by verbal report or chart review
* Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principal investigator
* Subjects who are unable or unwilling to cooperate with clinical testing
* Subjects having any impairment, activity or situation that, in the judgement of the study coordinator or PI, would prevent satisfactory completion of the study protocol
C: Inclusion Criteria:

1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy
2. Chronic pain as a result of FBSS that exists for at least 6 months
3. ≥ 18 years of age
4. Written consent of the patient to participate in study procedures.

Exclusion Criteria:

1. Active malignancy
2. Addiction to any of the following: drugs, alcohol and/or medication
3. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
4. Local infection or other skin disorder at site of surgical incision
5. Pregnancy
D: 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.

Answer: B