A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain

Abstract

Purpose A 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. Methods Consecutive 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. Results Median 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. Conclusions Minimally 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. Key pointsTake Home Messages 1. Patients treated with RF ablation of the BVN reported significant improvements from baseline in ODI, VAS, SF-36 and EQ-5D-5L at 3 months.2. This study reaffirms, using a "real-world" environment, the results of a prior efficacy trial on the role of radiofrequency ablation of the BVN for treatment of vertebrogenic CLBP.3. Using straight-forward, objective MRI findings for patient selection, these data collectively support a favorable risk/benefit profile for RF ablation of the BVN in a population of CLBP patients with few validated treatment alternatives.

Developments in Minimally Invasive Surgical Options for Vertebral Pain: Basivertebral Nerve Ablation – A Narrative Review

“…Of these, 50% discontinued opioid use at the 3-month follow-up post procedure and none increased their dose or required new opioid medication. 7 In contrast, Khalil et al reported that 32% of patients on their study used opioids at baseline, and no significant difference was observed between the two treatment arms at 3-months. 8 Fischgrund et al reported that of the 106 patients in the 2-year follow-up group, 28 had been taking opiates at baseline.…”

“…By including patients with moderate spinal stenosis, on extended-release opiates, and with a history of lumbar surgery the sample, although small, does approach a more generalizable population, which is arguably more representative of our spine population in daily clinical practice. 7 …”

“…The study reported a significant improvement in EQ-5D-5L (0.198 ± 0.129) and SF-36 from 31.62 at baseline to 47.41 at 3-month for the physical component, and preoperative 51.01 and 55.24 at 3-month follow-up for the mental component of SF-36, similar to previous studies that were statistically significant (p<0.0001). 7 …”

“…In the Truumees et al 2019 study, >78% of subjects enrolled considered the treatment with BVN RFA a success to improve their pain and function, and were satisfied with their outcomes, however this was subjectively reported and not using the MacNab criteria. 7 Kim et al 2018 assessed the MacNab criteria at one-week follow-up, while the study by Kim et al 2020 assessed MacNab criteria at an indeterminate length of time post procedure. The 2018 study revealed a success rate of 92.9% at 1-week follow up and the 2020 study revealed a 93% success rate (good to excellent satisfaction) at unspecified follow-up periods.…”

“…Lack of Kim’s signs was associated with overall fair outcomes based on MacNab’s criteria and less clinically significant improvement in ODI and VAS; No specific final follow-up period. Markman et al 2019 10 Neurosurgery Post-hoc analysis of sham-controlled trial 69 12 months N/A Treatment arm: Patients reporting increased opioid use - increased from 12.1 to 41.8 mME Patients reporting decreased opioid use - decreased from 15.4 to 4.0 mME Sham arm: Patients reporting increased opioid use - increased from 14.0 to 26.0 mME Patients reporting decreased opioid use - decreased from 24.2 to 3.9 mME N/A Increased use= 10 or more mME/day increase, Decreased use= 10 or more mME/day decrease Khalil et al 2019 8 The Spine Journal Prospective, randomized, multicenter 104 3 months N/A No significant difference in opioid reduction was observed between the two treatment arms at 3 months ODI improvement ≥ 10: 74.5% in treatment arm versus 32.7% in control (p<0.001) ODI improvement ≥ 20: 62.7% in treatment arm versus 13.5% in control (p<0.001) VAS improvement ≥ 2: 72.5% in treatment arm versus 34% in control (p<0.001) Interim analysis showed clear statistical superiority; included patients on extended release narcotics, history of discectomy/laminectomy Fischgrund et al 2019 6 International Journal of Spine Surgery Prospective, randomized, double-blind, sham-controlled, multicenter 106 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months N/A N/A ODI imrovement ≥ 10: 3 months- 75.6% (96/127) 12 months- 76.4% (81/106) ODI improvement ≥ 20: 3 months- 48% (61/127) 24 months- 57.5% (61/106) VAS improvement ≥ 1.5 cm: 3 months- 65.4% (83/127) 24 months- 70.2% (73/104) Due to high crossover rate, radiofrequency ablation treated participants acted as their own control in a comparison to baseline for the 2-year outcomes; Results represent the per-protocol treatment population Truumees et al 2019 7 European Spine Journal Prospective, open-label, single-arm, multicenter 28 …”