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: Inclusion Criteria:

* Patients with an implanted neurostimulation system met een FBSS met geïmplanteerd

Exclusion Criteria:

* no knowledge of the Dutch language
* Addicted to drugs
B: Inclusion Criteria:

* age 18-60, Rome II criteria, abdominal pain \>4 (0-10 VAS), stable symptoms for \>2 years

Exclusion Criteria:

* other gastrointestinal disease, somatic or psychiatric co-morbidity
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:

* Moderate-to-severe PDP in the lower limbs

  * The pain intended to treat has been present for more than 12 months
  * Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories:
  * Amitriptylin or an other tricyclic antidepressant and/or
  * Pregabalin (Lyrica®) or Gabapentin (Neurontin®) and/or
  * Duloxetine (Cymbalta®) and/or
  * Tramadol or strong opioids Patients were treated with 3 drugs from the above mentioned drug categories and followed the treatment algorithm for painful diabetic polyneuropathy according to Jensen. Starting dosage was based on individual patient characteristics. Each drug was tried for at least 3 weeks and dose was raised once, if possible. By insufficient pain relief and/or unacceptable side-effects, the drug treatment was stopped. Patients reached a steady state in medication use and it is not allowed to increase dosage during the study.
* Mean pain intensity during daytime and/or night time should be 5 or higher measured on a numeric rating scale (NRS). Pain during daytime will be scored 3 times per day during for 4 days according to Jensen.
* Patient's age is between 18 and 75 years.

Exclusion Criteria:

* The patient has had neuromodulation therapy during the month before the intake
* Neuropathic pain is most prevalent in the upper limbs (NRS\>3)
* Neuropathy or chronic pain of other origin than diabetes mellitus (NRS\> 3)
* Addiction: drugs, alcohol (\> 5E / day) and/or medication

  * Drugs: cocaine, heroine, marihuana.
  * Alcohol: wine, beer, liquor (max 5E / day)
  * Medication: benzodiazepines.
* Insufficient cooperation from the patient (little motivation, understanding or communication)
* Blood clotting disorder, when using 2 or more different kinds of anti coagulation
* Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to \> prednisolone 10 mg, immunodepressive, etc.)
* Peripheral vascular disease without palpable peripheral pulses at both feet (inclusion is possible if pulses are absent, but ankle brachial index is between 0.7 and 1.2 in both feet)
* Active foot ulceration
* Life expectancy \< 1 year
* Pacemaker
* Local infection or other skin disorders at site of incision
* Psychiatric problems potentially interfering with cooperation in the study
* Pregnancy
* Severe cardiac or pulmonary failure (\> NYHA classification II)
* Unstable blood glucose control (change in HbA1c\>1,0% in three months prior to inclusion)

Answer: C