Burst Spinal Cord Stimulation for Chronic Radicular Pain After Lumbar Spine Surgery A Randomized Double-Blind Sham-Controlled Crossover Trial

What this Trial Is About

Researchers are studying the use of spinal cord stimulation (SCS) to treat chronic radicular pain that persists after lumbar spine surgery. This pain is neuropathic and difficult to manage with non-surgical treatments. Traditional SCS works by replacing pain sensations with a tingling feeling called paresthesia, which some patients find uncomfortable. A newer approach called "burst" SCS delivers high-frequency electrical stimuli without causing paresthesia, potentially providing better pain relief for low back and leg pain. The study is a randomized, double-blind, sham-controlled crossover trial designed to evaluate how effective burst SCS is for this type of chronic pain. The study involves implanting a device called the ProclaimTM XR implantable pulse generator along with an Octrode4-contact lead under the skin for long-term therapy. Participants will receive burst SCS, which uses complex programming to deliver high-frequency bursts at 40 Hz with spikes at 500 Hz. There is also a sham stimulation condition where no spinal cord stimulation is provided. The trial includes a crossover design, meaning participants will experience both burst stimulation and sham stimulation at different times, without knowing which one they are receiving. Participants will be assessed for changes in their disease-specific functional outcomes over 12 months. Before the trial, they must have a successful two-week testing period with tonic SCS that reduces their leg pain by at least 2 points or 50% on the pain scale. Throughout the study, researchers will monitor pain levels and functional improvements to see how well the burst SCS works compared to no stimulation. The total involvement includes device implantation, stimulation periods, and follow-up evaluations to ensure safety and effectiveness.

Burst Crossover Trial