Abstract
Introduction
Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades. But despite global favorable outcomes in Failed Back Surgery Syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. Their efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. ESTIMET is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono vs multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain.
Material and Methods
FBSS patients with a radicular pain VAS score ≥ 50mm, associated with a significant back pain component were recruited in 14 centers in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12 months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction ≥ 50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption.
Results
Trial recruitment started in May 2012 and closed in October 2013. The 14 study centers have been initiated. The last visit last subject was performed in January 2015. This study received funding in 2012 from the French government NHS program “PSTIC 2011” (Program de Soutien aux Techniques Innovantes et Coûteuses). Each patient provided informed consent and approval was requested and obtained from the Poitiers University Hospital Ethics Committee (CPP Ouest III), the French National Agency for Medicines and Health Products Safety (ANSM) and the French Data Protection Authority (CNIL, No. 70108724P).
Conclusion
Preliminary results are expected to be analyze for the end of 2015 and published at the start of 2016.