Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.


Options:
A: 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.
B: Inclusion Criteria:

1. Have been diagnosed with chronic, intractable pain of the trunk and/or limbs which has been refractory to conservative therapy for a minimum of 3 months.
2. VAS ≥ 5
3. Be 18 years of age or older at the time of enrollment
4. Be willing and able to comply with study-related requirements, procedures, and visits
5. Be willing and capable of giving informed consent

Exclusion Criteria:

1. Pregnancy or potential for with unwillingness to use contraception
2. Have a current diagnosis of a coagulation disorder, bleeding diathesis
3. Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control
4. Have a life expectancy of less than 1 year
5. Have a condition currently requiring or likely to require the use of diathermy
6. Other inappropriate situations determined by the researcher
C: Inclusion Criteria:

1. Adults over the age of 18
2. Onset of low back pain \> 12 months
3. Low back pain intensity \> 60 out of 100mm on pain visual analogue scale (VAS)
4. Presence of clear component of neuropathic pain based on a PainDETECT Questionnaire score of \>19 (we will monitor this inclusion criteria in the early stage of the trial and revise if necessary)
5. Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography
6. On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator
7. Legally able to provide informed consent
8. Able to comply with study-related requirements, procedures and visits

Exclusion Criteria:

1. Had previous spinal surgery
2. Chronic widespread pain
3. Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.)
4. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumour, or severe/critical central or foraminal spinal stenosis
5. Mechanical spine instability detected by a clinician (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by \>5 degrees segmental angular movement) e.g. any forms of spondylolisthesis
6. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
7. Bleeding diathesis such as coagulopathy or thrombocytopenia
8. Immunocompromised and at an increased risk for infection
9. Systemic infection or local infection that would contraindicate SCS placement
10. Metastatic malignant disease or active local malignant disease
11. Pregnant (if female and sexually active, subject must be using a reliable form of contraception, be surgically sterile or be at least 2 years post-menopausal)
12. Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication.
13. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
14. Concomitant participation in another clinical trial (surgery, device or drug)
D: Inclusion Criteria:

* Males or females at least 18 years of age, of any ethnic origin
* Type 1 or 2 diabetes mellitus
* Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

* Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
* Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Answer: D