Abstract
BACKGROUND CONTEXT Low back pain (LBP) continues to be a costly problem in the United States. Unfortunately, current treatment options are limited when patients have predominantly LBP without instability or radicular symptoms. Neuromodulation has been shown to be effective, particularly in patients with chronic pain conditions such as failed back surgery and chronic regional pain syndrome. As such, the field of neuromodulation is evolving and spinal cord stimulator (SCS) implantation may provide a benefit to individuals who have chronic otherwise non-operable LBP. Considering SCS continues to advance with respect to stimulation parameters (eg, frequency, burst), combined with recent reports of improvements in both radicular lower extremity pain and axial LBP, further investigation into how SCS may benefit individuals experiencing chronic non-operative axial LBP is warranted. PURPOSE The purpose of this study was to determine the effects of SCS implantation on reducing pain and disability in chronic axial LBP patients who failed conservative treatment. STUDY DESIGN/SETTING Retrospective pre-test/post-test observational study design. PATIENT SAMPLE Twenty-four patients with chronic axial LBP who underwent SCS implantation. OUTCOME MEASURES Pain (Visual Analog Scale-VAS) and Disability (Oswestry Disability Index-ODI). METHODS A total of 24 patients with chronic axial LBP underwent SCS implantation and 1-year followup. All patients were diagnosed with chronic axial LBP with minimal or no radicular pain and had failed conservative treatment for a minimum of 12 months. All patients had >70% reduction of pain with trial stimulator before referral for placement of permanent implant. Patients were excluded if their primary complaint was radicular leg pain, had previous lumbar surgeries, no response to trial stimulator, RESULTS Baseline (pre-SCS implantation) measures for VAS and ODI were 7.9±1.5 and 24.2±10.2, respectively. At 1-year follow-up (post-SCS implantation), VAS and ODI were 3.4±2.6 and 12.0±10.9, respectively. These findings represent statistically significant effect sizes and clinically meaningful improvements in both pain (56.6% reduction in VAS, P CONCLUSIONS Patients with axial non-operable LBP demonstrated significant improvements in pain and disability at 1-year post-SCS implantation as VAS and ODI scores both surpassed minimal clinically important difference thresholds. This demonstrates that neuromodulation may play an important role in decreasing the burden that chronic LBP places on society. As SCS implantation technology improves, there is an increasing role for spine surgeons to understand the role of neuromodulation in the management of patients with spinal conditions. Further randomized controlled trials are needed to compare SCS implantation to other treatment interventions for chronic axial LBP. FDA DEVICE/DRUG STATUS Boston Scientific Coverage Lead with Precision Spectra Spinal Cord Stimulator System (Approved for this indication)
Published Version
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