Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (MODULATE-LBP): A Trial Protocol

Abstract

Introduction Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. There is evidence demonstrating high frequency 10kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with Failed Back Surgery Syndrome (FBSS) but there is limited evidence in CNLBP without prior surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10kHz SCS for this population. Methods This is a multicentre double-blind randomised sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10kHz SCS plus usual care (intervention group) or sham 10kHz SCS plus usual care (control group) after full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. Primary outcome will be a 7 day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6-months adjusting for baseline outcome scores. Incremental cost per quality adjusted life year (QALY) will be calculated at 6-months and over the patient lifetime. Discussion The outcomes of this trial will inform clinical practice and healthcare policy on the role of high frequency 10kHz SCS for patients with CNLBP without prior surgery.