A Prospective, Single-Blinded, Dose-Response Study of Spinal Cord Stimulation (SCS) Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain

The study will involve the use of the Intellis Implantable Neurostimulator (Medtronic). The study will involve the use of 1000µs/100Hz stimulation in patients with chronic neuropathic low back pain. The system will be trialled in 2 stages. The first half (3-5 days) of the trial will use commercially established MDT high-density (HD) paraesthesia-free stimulation. The second half (next 3-5 days) of the trial will use a paraesthesia-free (sub-perception) waveform (1000µs/100Hz) at 80% stimulation threshold (80% of the amplitude – voltage – corresponding to 100% stimulation perception). If either stage of the trial is successful, the patient will be implanted. The patient will then experience the paraesthesia-free (sub-perception) waveform (1000µs/100Hz) at 80% stimulation threshold (80% of the amplitude – voltage – corresponding to 100% stimulation perception) for 6 weeks. Following this 6-week stimulation establishment experience, descending levels of stimulation threshold will be applied by the programmer each month by stepping down the amplitude (voltage) to achieve 60% sub-perception, then 40% for the last 4 week treatment period. Patient-reported outcomes (pain scores, QOL, satisfaction level, etc.) at each of these levels will be clinically assessed to identify patient response to each sub-perception level of stimulation. The study will be conducted a private research facility by a team of 3 Pain Specialists including the Principal Investigator who has over 20 years experience and has conducted 60+ clinical studies.