Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-Center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain
Brief Summary: This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.


Options:
A: Inclusion Criteria:

* age 18-60, Rome II criteria, abdominal pain \>4 (0-10 VAS), stable symptoms for \>2 years

Exclusion Criteria:

* other gastrointestinal disease, somatic or psychiatric co-morbidity
B: Key Inclusion Criteria:

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
3. Qualifying pain score
4. Be on stable pain medications, as determined by the Investigator
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
7. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent

Key Exclusion Criteria:

1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
5. Have any addictions as determined by the Investigator
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have prior experience with neuromodulation devices
8. Other general exclusions applicable for SCS devices
9. Be involved in an injury claim under current litigation
10. Have a pending or approved worker's compensation claim
C: Inclusion Criteria:

* Neuropathic pain \> 6 months
* Pain intensity ≥ 5 according to NRS (for neuropathic pain component to be treated with SCS)
* Known cause of the pain
* Neuroanatomical correlation to the pain
* ≥50% of the painful area is to be treated with SCS
* The patient has a physical and psychological health status that allows the patient to participate in physiotherapy and undergo SCS implantation.

Exclusion Criteria:

* Not able to undergo SCS implantation
* Inadequate knowledge of the Swedish language
* Alcohol or substance abuse
* Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
* Incapacitating pain conditions of other causes than neuropathic pain
* Pregnancy
* Insufficient compliance
* Malignant disease with short expected survival
D: 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)

Answer: B