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:

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)
B: Inclusion Criteria:

1. A diagnosis of primary or idiopathic erythromelalgia
2. Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.
3. Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.
4. Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.

Exclusion Criteria:

1. Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).
2. History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
3. Abnormal pain behavior and/or unresolved psychiatric illness.
4. Unresolved issues of secondary gain or inappropriate medication use.
5. Unfit for participation for any other reason as judged by the study physician.
C: 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
D: Inclusion Criteria:

1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy
2. Chronic pain as a result of FBSS that exists for at least 6 months
3. ≥ 18 years of age
4. Written consent of the patient to participate in study procedures.

Exclusion Criteria:

1. Active malignancy
2. Addiction to any of the following: drugs, alcohol and/or medication
3. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
4. Local infection or other skin disorder at site of surgical incision
5. Pregnancy

Answer: A