Spinal Cord Stimulation for Therapy-Resistant Neuropathic Pain After Lumbar Spinal Surgery A Randomized, Double-Blind, Sham-Controlled, Cross-over Study

What this Trial Is About

Researchers are evaluating spinal cord stimulation (SCS) as a treatment for persistent neuropathic leg pain that continues after lumbar spinal surgery and does not improve with medication or other conservative treatments. This study is a multicenter, double-blind, randomized, sham-controlled trial designed to compare the long-term effects of active, subthreshold SCS versus no stimulation (placebo) on reducing neuropathic leg pain in patients with persistent spinal pain syndrome type 2 (PSPS2). The study aims to assess not only pain reduction but also quality of life, physical functioning, sleep quality, return to work, and medication use. Participants who respond positively to a two-week SCS test trial will have a non-rechargeable Boston Alpha Prime SCS system implanted. After initial electrode implantation and a trial phase, those with adequate pain relief will receive a permanent implant. The study includes a four-week optimization period followed by a six-month randomized crossover phase where patients receive either active subthreshold stimulation or sham stimulation for three months each. Then, participants will use their preferred stimulation form for an additional six months. Both patients and physicians remain unaware of the stimulation status during the blinded phases, with only a research nurse managing programming. During the study, participants will complete questionnaires before implantation and at regular follow-ups at 3, 6, and 12 months. Researchers will monitor changes in leg pain intensity using the Numeric Rating Scale (NRS) and evaluate secondary outcomes such as quality of life and physical function. After completing the 12-month follow-up, blinding will be lifted, and participants may choose any available stimulation form. The total participation duration is approximately one year, including surgery, stimulation phases, and follow-up assessments.

Placebo Effect In Spinal Cord Electrical Stimulation for Pain