Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

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