Journal d'anesthésiologie et de recherche sur la douleur

Blinded Efficacy Testing of High Frequency Spinal Cord Stimulation

Abstract

Damoon Rejaei, Gary J Brenner

Objective: Traditional spinal cord stimulation (SCS) relies on paresthesias to mask patients’ pain perception. This restricts the high-quality evaluation of SCS’s efficacy. 10-kHz high-frequency (HF10) therapy, however, is a paresthesia-free modality of SCS. As such, the introduction of this technology creates the opportunity to evaluate SCS’s efficacy with appropriate patient and provider blinding to treatment. We report a case of a patient with axial low back pain who, without her knowledge, underwent “blinded” testing of the device by her spouse.
Case: A 66 year-old female with four years of axial low back pain and a diagnosis of post-laminectomy syndrome presented for consultation after failing multiple medical and surgical treatments. HF10 SCS trial provided her with greater than 50% pain relief with reduction in her opioid consumption. As such, decision was made to pursue permanent implantation. Without her knowledge, the patient underwent ‘blinded’ testing of the devise’s efficacy by her spouse who repeatedly inactivated (and subsequently activated) the stimulator while she slept.
Discussion: This is the first report to evaluate the efficacy of HF10 in treating chronic axial low back pain where the patient was truly blinded to the SCS treatment (i.e., she did not know if the device was on or off). Future studies can lead to appropriately blinded randomized control studies to generate high-level evidence for HF10’s efficacy and harm in a variety of pain condition.