Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain

Inclusion Criteria:

1. Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back painfor the past week), which has been refractory to conservative therapy for a minimumof 3 months.

2. Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.

3. Is currently considered medically stable as judged by investigator.

4. Able to operate the SCS device (e.g., using remote control) and charge the deviceappropriately.

5. Determined to be a good surgical candidate by the investigator.

6. Willing to sign the Human Research Ethics Committee (HREC) approved informed consentand deemed capable of complying with the requirements of the study protocol.

7. Willing to stay on stable medications until implantable pulse generator (IPG)activation (i.e., from IPG implant to IPG activation, except for usual postoperativemedications required following IPG insertion).

8. Able to comply with study requirements and attend all scheduled visits.

9. Eighteen (18) years of age or older.

10. Literate, able to speak English and able to complete questionnaires independently.

Exclusion Criteria:

1. Diagnosis of active disruptive psychological or psychiatric disorder or other knowncondition significant enough to impact perception of pain, compliance, interventionand/or ability to evaluate treatment outcome as assessed by a clinical psychologistor psychiatrist in a psychological assessment performed at Baseline.

2. Chronic pain in any area other than back or legs, such that it precludes subject'sability to assess their pain for the primary indication of chronic low back pain asdetermined by Investigator.

3. Previous experience with implantable neuromodulation devices (e.g., spinal cordstimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).

4. Opioid usage with average total daily morphine equivalent dose (MED) of >60 mg.

5. A known need for an MRI or surgery within a 2-week period of the screening visitthrough the end of the study.

6. Female candidates of childbearing potential that are pregnant (confirmed by positiveurine/blood pregnancy test) or plan to get pregnant during the duration of thestudy.

7. Subject is participating in another interventional clinical trial.