A Randomized, Controlled, Multi-Center, Non-Inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with/without Leg Pain

INTERVENTION: The purpose of this study is to compare the safety and efficacy of Ultra‐Low Frequency Spinal Cord Stimulation (ULF‐SCS Presidio System) to Traditional Spinal Cord Stimulation (SCS) over a 15 day period in subjects with chronic, intractable back pain with/without leg pain. The Presidio Medical ULF‐SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) and low frequency (1‐500Hz) electrical currents to the epidural space to block the conduction of nerve pain. The participants will have epidural leads implanted for 15 days in an operating room setting. It will be performed by a pain management specialist surgeon in a day surgery setting under general or sedation anaesthesia with a procedure lasting approximately 1 hr. The trial system consists of epidural leads (implanted in the T8‐T10 region), lead adapters, an external pulse generator (EPG), surface electrodes and a programming application. The participant will wear the EPG on a hip belt and will have control to continue, pause or stop stimulation. The participant will return to the clinic at days 1, 3 and 7 to adjust their stimulation. The device is anticipated to provide near continuous stimulation throughout the trial though it is able to be paused or stopped by the participant. The entire system will be removed at Day 15. The usage data from the device will be downloaded at every clinic visit to assess for total run time and device performance. The study utilizes a multi‐centre, prospective, randomized, controlled, non‐inferiority two‐arm design. Randomization to a control Group allows for the ability to discriminate between improvement in outcomes due to the investigational treatment vs standard therapy. The nature of the two types of stimu CONDITION: Lower Back Pain;Leg Pain; ; Lower Back Pain ; Leg Pain Musculoskeletal ‐ Other muscular and skeletal disorders Neurological ‐ Other neurological disorders PRIMARY OUTCOME: The primary safety endpoint will be the percentage of subjects that experience one or more device, procedure, and/or stimulation related adverse events in the ULF‐SCS group compared to the Traditional SCS group. Adverse events will be assessed via clinical examination as well as participant self‐reported signs and symptoms. These will be reviewed in detail by the Investigators and recorded as appropriate. A DSMB will review all adverse events. Examples of known/possible adverse events include paresthesia in unwanted areas, pain at the implant site, infection, tingling sensation. These will be discussed with you at the time of your initial visit. [; Adverse events will be collected at the following visits:; Baseline visit, Day 0, Day 1, Day 3, Day 7, Day 15 and Day 23. ] The primary efficacy endpoint will be a review of mean change in VAS score for back pain intensity from baseline to Day 15 Day 15 between ULF‐SCS and Traditional SCS.; ; [Data will be collected at all participant visits including Day 0 (implant procedure) through to Day 23 (study Exit). ] ; • Mean change in VAS score for pain intensity in leg pain from baseline to Days 3, 7, and 15 ; ; [This outcome will be assessed from Baseline through to Day 3, Day 7 and Day 15. ] INCLUSION CRITERIA: 1. Eighteen (18) years of age or older 2. Literate, able to speak English and able to complete questionnaires independently 3. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 5. Are currently receiving optimal medical management and considered medically stable as judged by investigator 6. Ability to independently change AA batteries and operate EPG. 7. Able to comply with study requirements and attend all scheduled visits SECONDARY OUTCOME: Mean change in Oswestry disability Index (ODI 2.1a) score from baseline to Days 3, 7, and Day 15. [ODI will be collected at Baseline, Days 3, 7 and 15. ] Percentage of pain relief will be determined by calculating individual participant's change in pain score from baseline by calculating individual participant's change in pain score from baseline at Days 7 and 15. This will be a composite secondary outcome of the percentage of participants with 100%, 50% or greater and 80% or greater pain relief. VAS (Visual Analogue Score Questionnaire) will be used to calculate the pain score. [Percentage Pain Relief will be assessed at Days 7 and Days 15. ] Percentage of subjects in each ODI category at baseline.[This timepoint will be assessed at Days 7 and Day 15. ] Percentage of subjects with a clinically meaningful change (defined as a 15 point or greater decrease) from baseline in ODI score on Days 7 and 15[This timepoint will be assessed at Days 7 and Day 15. ] The secondary efficacy endpoints for this study will include a comparison between ULF‐SCS and Traditional SCS for the following measures: 4. Have been diagnosed with chronic low back pain with/without associated leg pain (VAS greater than 50mm for the past week), which has been refractory to conservative therapy for a minimum of 3 months