Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.


Options:
A: Inclusion Criteria:

* Subject is male or female between the ages of 18 and 80 years.
* Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
* Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
* Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

* Have 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.
* Have 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 outcomes.
* Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
* Have prior experience with SCS.
* Have an active systemic infection or local infection in the area of the surgical site.
* Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
* Be concomitantly participating in another clinical study.
B: Inclusion Criteria:

* Age ≥ 18 years or ≤ 80 years.
* Subject has FBSS and does not require further surgery. For the purposes of this study, FBSS is 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.
* Subject has persistent low back and leg pain despite other treatment modalities (pharmacological, surgical, physical, or psychological therapies) that have been tried and did not prove satisfactory or are unsuitable or contraindicated for the subject.
* Average global pain is ≥ 50 mm as assessed by the baseline VAS.
* With significant back, with mean intensity on a back pain VAS ≥ 50 mm (mean daily VAS score calculated on 5 consecutive days).
* Meeting the criteria for spinal cord stimulation test according to HAS guidelines (multidisciplinary consultation, psychological assessment, etc.).
* Subject is a candidate for SCS.
* Absence of active psychosis or history of serious psychotic illness requiring hospitalisation.
* Understands and accepts the constraints of the study.
* Free subject, not under temporary or permanent guardianship and not subject to subordination.
* Patients covered by French national health insurance.
* Patients who have given their written consent to the study after having received clear information.

Exclusion Criteria:

* Age \< 18 years or \> 80 years
* Subject is or has been 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.
* Cause of low back pain accessible to etiological "mechanical" surgical treatment (discogenic low back pain, vertebral instability, spinal deformity, etc.).
* Subject had most recent back surgery less than 6 months ago.
* Presenting a surgical, anaesthetic or psychiatric contraindication to implantation of a spinal cord stimulation system.
* Based on the opinion of the principal or sub-investigator, the subject is unable to operate the SCS equipment.
* Subject has a life expectancy of less than 24 months beyond study enrolment.
* Absence of signature of the informed consent form.
* Patients not covered by French national health insurance.
* Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting.
* Pregnant women, nursing mothers, women of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).
C: 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
D: Inclusion Criteria:

1. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
2. Age ≥ 18 years
3. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
4. Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care
5. Patient has not had spine surgery for back or leg pain
6. Patient is a candidate for spinal cord stimulation
7. Low back pain ≥ 6 on Numerical Rating Scale
8. Oswestry Disability Index score of ≥ 30%
9. Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan

Exclusion Criteria:

1. Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
2. Primary complaint of leg pain, or leg pain is greater than back pain
3. Back pain is due to any of the following:

   * spinal instability defined as \> 2 mm translation on radiographic imaging
   * visceral causes (e.g., endometriosis or fibroids)
   * vascular causes (e.g., aortic aneurysm)
   * spinal infection (e.g., osteomyelitis)
   * inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)
   * tumor or spinal metastases
4. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)
5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
6. Neurological deficit (e.g. foot drop)
7. Prior lumbar spine surgery or sacroiliac joint fusion
8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days
9. Patient is bed bound
10. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement
12. Known allergic reaction to implanted materials
13. Severe scoliotic deformity (\>11 degrees in thoracic or lumbar spine)
14. Patient has a history of, or existing intrathecal drug pump
15. Patient has previous experience with neuromodulation devices, including a failed trial
16. BMI \> 40
17. Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel
18. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
19. Failed psychological evaluation
20. Suspicion or evidence of untreated mental illness, or substance abuse
21. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior
22. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
23. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

    * Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

Answer: A