Abstract
PurposeA prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion.MethodsConsecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates.ResultsMedian age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months posttreatment was − 30.07 +14.52 points (p < 0.0001); mean change in VAS was − 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93%) of patients achieved a ≥ 10-point improvement in ODI, and 75% reported ≥ 20-point improvement.ConclusionsMinimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.
Highlights
Chronic LBP affects more than 30 million U.S adults [1, 2]
Patients treated with radio frequency (RF) ablation of the basivertebral nerve (BVN) reported significant improvements from baseline in Oswestry Disability Index (ODI), visual analog scale (VAS), SF-36 and EQ-5D-5L at 3 months
Studies have demonstrated that vertebrogenic pain from degenerated or damaged vertebral endplates is an important source of chronic low back pain (CLBP)
Summary
Chronic LBP affects more than 30 million U.S adults [1, 2]. While nonoperative management is often successful, recurrence is common and long-term disability has been reported in up to 17% [3]. Rates of traditional surgical intervention, i.e., fusion, and reported outcomes are highly heterogeneous [4]. Studies have demonstrated that vertebrogenic pain from degenerated or damaged vertebral endplates is an important source of CLBP. The endplates are susceptible to damage due to their conflicting roles of providing nutritional support for the poorly vascularized disk and structural support for the spine. Endplate damage can lead to cellular communication between the immunologically privileged disk nucleus and vertebral bone marrow, triggering an inflammation—a process that can lead to Modic changes visible on MRI [7, 8]
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