Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
Brief Summary: Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.


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:

* At least 18 years old at the time of informed consent
* Willing and able to provide a signed and dated informed consent
* Capable of comprehending and consenting in English
* Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
* On a stable dose (no new, discontinued or changes in) of all prescribed pain medications and willing/able to maintain or only decrease the dose of all prescribed pain medications
* Tried appropriate conventional medical management for their pain
* Not indicated for additional surgical treatment in the opinion of the referring physician or spinal surgeon
* Undergone previous spinal surgery
* Diagnosed with FBSS with appropriate pain score
* Primary pain at appropriate spinal level

Exclusion Criteria:

* Has an active implanted device, whether turned on or off
* Displays current signs of a systemic infection
* Pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
* Has untreated major psychiatric comorbidity
* Has serious drug-related behavioral issues
* Has neurological abnormalities unrelated to Failed Back Surgery Syndrome
* Diagnosed with Raynaud disease
* Diagnosed with Fibromyalgia
* Has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
* Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
* Participating or planning to participate in another clinical trial
* Has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
C: Inclusion Criteria:

* The patient must have SCS implanted for at least 2 months before study start date
* The patient must be at least 18 years old
* The patient must currently be receiving pain relief from SCS usage
* The patient must be willing to participate in a 9-week study
* The patient must have at least 20% of battery life remaining in his/her spinal cord stimulator
* The patient must be able to tolerate Vicodin-Extra Strength as well as Tylenol, but can also take their own pain medication if it is not one of the two mentioned

Exclusion Criteria:

* The patient is pregnant or intends to become pregnant during the course of the study.
* The patient by report, and/or by physician assessment, exhibits any or all of the following, which might bias reporting of treatment outcome:

A strong untreated dependency on prescription medication such as benzodiazepines and narcotic analgesics.

A strong potential for secondary gain issues.

A significant, untreated psychiatric comorbidity.

* The patient possesses a coexisting clinically relevant or disabling chronic pain problem not treated by SCS
* The patient has been diagnosed with unstable angina
* The patient receives a Karnofsky's performance score of \<60
D: 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)

Answer: D