Please select the eligibility criteria that correspond to the clinical trial below.
Title: Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
Brief Summary: Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.


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:

Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):

1. Traumatic, thoracic SCI
2. Chronic pain (i.e., Pain \>3 for \> 3 months)
3. Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
4. 18-80 years of age
5. Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens

Exclusion Criteria:

Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):

1. Complete cord transection
2. Persistent spinal instability or other injury preventing ability to participate
3. Active infection
4. Comorbid psychosis or psychotic disorder
5. Untreated, clinically significant depression
6. Active drug or alcohol abuse
7. Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test
C: 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
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: A