Ensayos clínicos

Inclusion Criteria:

• Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery.
• Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain.
• Qualifying pain score.
• Be on stable pain medications, as determined by the Investigator.
• Be willing and capable of giving informed consent.
• Be willing and able to comply with study-related requirements, procedures and visits.
• 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

Exclusion Criteria:

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