Subcutaneous Peripheral Nerve Stimulation as “Hybrid Stimulation” after Failure of Spinal Cord Stimulation to Control the Back Pain Component in Failed Back Surgery Syndrome Patients. A Randomized Controlled Study (Cumpns)

IntroductionDespite globally favorable outcomes of SCS, a significant proportion of FBSS patients do not obtain adequate coverage of low back pain. PNS has obtained the CE mark in Europe for the treatment of chronic refractory neuropathic pain and is now commonly used in some countries to target back pain. However, the potential value of combining SCS and PNS as ”hybrid stimulation” remains poorly described with only isolated case reports or limited experience in various indications. The “CUMPNS” comparative randomized study is designed to demonstrate the potential analgesic efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain component pain in refractory FBSS patients.Material and MethodsAll patients are randomized 1:1 in to 2 groups (SCS+PNS vs SCS). Group 1 (SCS+PNS) receives “hybrid stimulation” with PNS implantation one month after the inclusion visit. In the second group, patients continue to be treated with SCS alone for 4 months post-inclusion before having ...