Please select the eligibility criteria that correspond to the clinical trial below.
Title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Brief Summary: Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.

'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.

The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.

The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.


Options:
A: Inclusion Criteria:

* SCS candidate with the Specify 5-6-5 surgical lead
* Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
* Average low back pain is ≥ 5 as assessed by the baseline NPRS
* Average low back pain is greater than leg pain
* Subject has persistent moderate to severe low back and leg pain despite other treatments

Exclusion Criteria:

* Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
* Most recent back surgery \< 6 months ago
* Low back pain only (no leg pain)
* Investigator suspects substance abuse that might confound the study results
* Radiographic evidence of instability requiring fusion
* Pain relieved completely by lying down
* Life expectancy of \< 24 months
* Subject is pregnant or planning to become pregnant during the course of the study
* Subject is unable to undergo study assessments or complete questionnaires independently
B: 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
C: 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.
D: Inclusion Criteria:

* Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
* Minimum pain intensity of 5/10 on the leg pain NRS at baseline
* Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
* Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital

Exclusion Criteria:

* Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
* History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
* Abnormal pain behavior and/or unresolved psychiatric illness.
* Unresolved issues of secondary gain or inappropriate medication use.

Answer: D