Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results

Koreckij, Theodore D.; Kreiner, Scott; Khalil, Jad G.; Smuck, Matthew; Markman, John D.; Garfin, Steven R.

doi:10.1016/j.xnsj.2021.100089

Cited by 14 publications

(32 citation statements)

References 30 publications

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“…This appears to be supported by the existing literature, in which the vast majority of study participants observed to initially benefit from BVN RFA continued to report significant pain and functional improvement at 1, 2, and 5 years ( Figures 2–5 ). This pattern appears to be the same in industry-funded [ 3 , 7–10 , 36 ] and independently performed studies [ 1 , 5 ]. Along with robust improvements in pain and function, healthcare utilization appears to decrease substantially after BVN RFA.…”

Section: Discussionmentioning

confidence: 60%

“…There were no disagreements among reviewers about study inclusion. These included one RCT comparing BVN RFA with sham, with outcomes reported at up to 1, 2, and 5 years [ 4 , 7 , 9 , 10 ]; one RCT comparing BVN RFA with standard care treatment, with outcomes reported at up to 3, 6, 12, and 24 months [ 8 , 11 , 36 ]; and four single-group cohort studies, with outcomes reported between 3 and 12 months [ 1 , 3 , 5 , 6 , 12 ].…”

Section: Resultsmentioning

confidence: 99%

“…The main characteristics of the included studies are summarized in Table 1 . From 2017 to 2021, a total of 414 participants were allocated to receive BVN RFA in two RCTs and four single-group cohort studies [ 1 , 3 , 5 , 7 , 11 , 12 , 36 ]. Participants in all reviewed studies were adults with chronic LBP for ≥6 months with MC1 and MC2 changes within at least one of the L3–S1 vertebral bodies.…”

Section: Resultsmentioning

confidence: 99%

“…Of the participants who were followed in the SMART trial, only 3% had received a lumbosacral facet joint RFA treatment or spinal injection in the year preceding the 5-year data collection time point [ 9 ]. Similarly, 5% of participants from INTRACEPT received an epidural steroid injection at a treated level by the 2-year data collection time point [ 36 ]. In both of these studies, a minority of participants progressed to a fusion surgery (8% and 4.5%, respectively).…”

Section: Discussionmentioning

confidence: 99%

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The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis

et al. 2022

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Objective To provide an estimate of the effectiveness of basivertebral nerve (BVN) radiofrequency ablation (RFA) to treat vertebrogenic low back pain (LBP). Design Systematic review with single-arm meta-analysis. Population Persons ≥18 years of age with chronic LBP associated with type 1 or 2 Modic changes. Intervention Intraosseous BVN RFA. Comparison Sham, placebo procedure, active standard care treatment, or none. Outcomes The proportion of patients treated with BVN RFA who reported ≥50% pain score improvement on a visual analog scale or numeric rating scale. The main secondary outcome was ≥15-point improvement in Oswestry Disability Index score. Methods Three reviewers independently assessed articles published before December 6, 2021, in MEDLINE and Embase. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to evaluate the overall quality of evidence. Results Of the 856 unique records screened, 12 publications met the inclusion criteria, representing six unique study populations, with 414 participants allocated to receive BVN RFA. Single-arm meta-analysis showed a success rate of 65% (95% confidence interval [CI] 51–78%) and 64% (95% CI 43–82%) for ≥50% pain relief at 6 and 12 months, respectively. Rates of ≥15-point Oswestry Disability Index score improvement were 75% (95% CI 63–86%) and 75% (95% CI 63–85%) at 6 and 12 months, respectively. Conclusion According to GRADE, there is moderate-quality evidence that BVN RFA effectively reduces pain and disability in most patients with vertebrogenic LBP. Further high-quality studies will likely improve our understanding of the effectiveness of this procedure.

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Section: Discussionmentioning

confidence: 60%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis

et al. 2022

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“…This evidence has driven the development of therapeutic interventions designed to denervate such pain generators. Such treatments substantially improve pain and function when provided to well-selected patients [ 11 , 12 , 23 , 24 ].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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.

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Basivertebral nerve ablation for the treatment of chronic low back pain in a community practice setting: 6 Months follow-up

Schnapp

Martiatu

Delcroix

2023

North American Spine Society Journal (NASSJ)

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Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results

Abstract: on behalf of the INTRACEPT trial investigators, Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results,

Cited by 14 publications

References 30 publications

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis

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

Basivertebral nerve ablation for the treatment of chronic low back pain in a community practice setting: 6 Months follow-up

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