Leg and/or Back Pain After Failed Back Surgery

This research study aims to evaluate the safety and effectiveness of the Nalu Medical Neurostimulation System to treat chronic pain of the legs and/or back after failed back surgery. The Nalu Spinal Cord Stimulator System is experimental and not listed on the Australia Register (TGA) and as such is not registered for supply or use in Australia outside this Clinical Trial.  This is a First in Human study for this Device and Nalu Medical has developed this device that is smaller and has an external battery unlike the commercially available devices.

There will be at least 12 visits over a 14-month period in our Hurstville trial site. There will be no cost to participate in the trial and participants may be reimbursed for costs associated with travel for each visit.

Eligibility

• Male or female, 21 to 80 years old
• History of intractable neuropathic pain of the legs and/or back for at least 6 months
• Diagnosed with failed back surgery syndrome (FBSS), and it has been at least 6 months from the last back surgery
• Has undergone conservative pain management (e.g. physiotherapy, chiropractor, acupuncture, ultrasound, anti-inflammatory medications, spinal injections and radiofrequency)