Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data

Abstract

Objective Develop pain location “maps” and investigate the relationship between low back pain (LBP)-exacerbating activities and treatment response to basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically suspected vertebral endplate pain (VEP). Design Aggregated cohort study of 296 patients treated with BVN RFA at 33 centers in three prospective trials. Methods Participant demographics, pain diagrams, and LBP-exacerbating activities were analyzed for predictors using stepwise logistic regression. Treatment success definitions were: (1) ≥50% LBP visual analog scale (VAS), (2) ≥15-point Oswestry Disability Index (ODI), and (3) ≥50% VAS or ≥15-point ODI improvements at 3 months post-BVN RFA. Results Midline LBP correlated with BVN RFA treatment success in individuals with clinically-suspected VEP. Duration of pain ≥5 years (OR 2.366), lack of epidural steroid injection within 6 months before BVN RFA (OR 1.800), lack of baseline opioid use (OR 1.965), LBP exacerbation with activity (OR 2.099), and a lack of LBP with spinal extension (OR 1.845) were factors associated with increased odds of treatment success. Regressions areas under the curve (AUCs) were under 70%, indicative of low predictive value. Conclusions This study demonstrates that midline LBP correlates with BVN RFA treatment success in individuals with VEP. While none of the regression models demonstrated strong predictive value, the pain location and exacerbating factors identified in this analysis may aid clinicians in identifying patients where VEP should be more strongly suspected. The use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain remain the most useful patient selection factors for BVN RFA.

Modic changes as seen on MRI are associated with nonspecific chronic lower back pain and disability

“…We do recognise that having published their review protocol in Prospero they had limited freedom to do so. Unfortunately, Herlin et al is often being inappropriately cited as demonstrating no association between LBP and MC without acknowledging its limitations [30][31][32][33][34][35][36][37][38], but others do cite it in a more appropriate nuanced way [23,[39][40][41][42][43][44][45][46][47][48][49].…”

“…Papers citing Herlin et al were identified using Pub-Med [23,[30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49]. The literature was searched through PubMed with the keywords "MRI (back pain) association Modic" restricted to the last 5 years and identified 135 articles.…”

“…BVNA treatment provided lasting and clinically significant reductions in pain and disability, with 64% (95% CI 43-82%) and 75% (95% CI 63-85%) of subjects reporting ≥ 50% pain reduction and ≥ 15-point reduction in Oswestry Disability Index at 12 months [27]. Patients with nonspecific CLBP can present with multiple MRI findings, but only the presence of axial lower back pain and MC1 or MC2 changes was predictive of the success of BVNA [23].…”

“…Until now, the field has been largely observational. With the observed clinical benefit in randomised controlled trials of basivertebral nerve ablation (BVNA) and its subsequent regulatory approval for the treatment of patients with MC1 and MC2 endplate oedema and vertebrogenic pain, the importance of identifying Modic changes has been recognised [5,[23][24][25][26]. BVNA treatment can provide clinically significant reductions in pain and disability [27].…”

“…BVNA treatment can provide clinically significant reductions in pain and disability [27]. The contribution of vertebral endplate and marrow damage, observed as MC1 or MC2 changes on MRI, to CLBP is becoming more widely appreciated and has led to the endorsement of the diagnostic selection of CLBP patients with MC1 or MC2 changes and the BVNA procedure by US learned societies [23,24]. The medical history and MRI-based diagnosis of vertebrogenic pain has been recognised with an International Classification of Diseases (10th Revision) diagnostic code M54-51 [28].…”