Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Brief Summary: This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.


Options:
A: Inclusion criteria:

* Patients 18 - 70 years old. For patients who only participate in the clinical RCT (without fMRI) no upper age limit.
* CRPS affecting one single upper or lower limb diagnosed by the IASP (2012) Budapest research criteria (Harden et al., 2010).
* Triggering trauma or the onset of pain \>3 months ago.
* If possible drugs that can influence the fMRI scans should be avoided. Documentation if used.

Exclusion criteria

* Drug abuse.
* Malignant/progressive, systemic or neurodegenerative disease.
* Other severe pain conditions.
* Severe clinical anxiety or depression, symptoms of fatigue or ME of a disabling level.

For patients who participate in the MRI related analyses:

* Metallic implants incompatible with the MR technology or medical condition not recommended for fMRI.
* Pregnancy.
* Phobia for MRI examination.
* Diseases that can cause structural changes and interfere with the interpretation of the MRI-scans (like severe diabetes mellitus, heart disease, ischemic stroke and vascular conditions).
B: Key Inclusion Criteria:

* Chronic low back pain, with or without leg pain, for at least 6 months
* Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
* Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
* Require implantation of lead(s) in the cervical epidural space
* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
* Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
C: 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)
D: Inclusion Criteria:

* History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
* Understand Norwegian or Swedish language (written and spoken).
* Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)

Exclusion Criteria:

Absolute

* Opioid dose \> 100 mg morphine equivalents / day
* Ongoing litigation
* Mental / psychiatric disorder that may affect treatment
* Chronic generalized pain
* Pregnancy
* Hypersensitivity to local anesthetics
* Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders
* Laminectomy in or above level for planned epidural access
* Spine surgery the last 3 months

Relative

* Ongoing medication that affects coagulation or platelet function

Answer: D