The Relationship Between Patient Demographic and Clinical Characteristics and Successful Treatment Outcomes After Basivertebral Nerve Radiofrequency Ablation: A Pooled Cohort Study of Three Prospective Clinical Trials.

OBJECTIVE: Multiple studies have demonstrated the safety and effectiveness of basivertebral nerve radiofrequency ablation (BVN RFA) for improving low back pain related to the vertebral endplate. However, the influence of patient demographic and clinical characteristics on treatment outcome is unknown. DESIGN: Pooled cohort study of three clinical trials of patients with vertebral endplate pain identified by Type 1 and/or Type 2 Modic changes and a correlating presentation of anterior spinal element pain. SETTING: Thirty-three global study centers. SUBJECTS: Patients (n = 296) successfully treated with BVN RFA. METHODS: Participant demographic and clinical characteristics were analyzed with stepwise logistic regression to identify predictors of treatment success. Three definitions of treatment success were defined: 1) ≥50% visual analog scale pain improvement, 2) ≥15-point Oswestry Disability Index (ODI) improvement, and 3) ≥50% visual analog scale or ≥15-point ODI improvement from baseline. RESULTS: Low back pain of ≥5 years' duration and higher ODI scores at baseline increased the odds of treatment success, whereas baseline opioid use and higher Beck Depression Inventory scores reduced these odds. However, the three regression models demonstrated receiver-operating characteristics of 62-70% areas under the curve, and thus, limited predictive capacity. CONCLUSIONS: This analysis identified no demographic or clinical characteristic that meaningfully increased or reduced the odds of treatment success from BVN RFA. On the basis of these findings and the high response rates from the three analyzed trials, we recommend the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain to determine optimal candidacy for BVN RFA.

Intra-Articular Sacroiliac Joint Injection: Technical Guide.

Sacroiliac (SI) joint pathology has been an increasingly discussed pathology as a potential etiology for significant low back and lower extremity pain. While patient history and examination maneuvers can assist with identifying the SI joint as a potential cause of pain, an intra-articular SI joint injection is critical to properly diagnose the SI joint as a clinically relevant pain generator. In addition to the diagnostic information from the injection, SI joint intra-articular injections can be performed for therapeutic benefit as part of a multi-modal, conservative treatment approach for SI joint pathology. We discuss our technique for safe and effective SI joint intra-articular injections as a both diagnostic and therapeutic aid for SI joint pathology.

Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.

BACKGROUND: Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes. METHODS: In total, 117 US patients were treated successfully with BVN ablation. Patient-reported outcomes of ODI, VAS, postablation treatments, and patient satisfaction were collected at a minimum of 5-years following BVN ablation. Primary outcome was mean change in ODI. Comparisons between the postablation and baseline values were made using an analysis of covariance with alpha 0.05. RESULTS: Of the 117 US treated patients 100 (85%) were available for review with a mean follow-up of 6.4 years (5.4-7.8 years). Mean ODI score improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points (p < 0.001). Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p < 0.001). In total, 66% of patients reported a > 50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete pain resolution. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%. CONCLUSION: CLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.

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

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. These slides can be retrieved under Electronic Supplementary Material.

Selective nerve root injections can predict surgical outcome for lumbar and cervical radiculopathy: comparison to magnetic resonance imaging.

OBJECTIVE: Diagnostic selective nerve root injection (SNI) results were analyzed in 101 patients who underwent lumbar or cervical decompression for radiculopathy and compared to surgical outcome 1 year postoperatively. A comparison of surgical outcomes was also examined between magnetic resonance imaging (MRI) and SNI results. RESULTS: Of the 101 patients, 91 (90%) had positive and 10 had negative SNI results at the level operated. Ninety-one percent of the patients with a positive SNI had good surgical outcomes, whereas 60% of the patients with a negative SNI had good outcomes. Of the patients with a positive MRI result, 87% had good surgical outcomes, whereas a similar percentage of the patients with a negative MRI (85%) had good surgical outcomes. When findings between SNI and MRI differed (n = 20), surgery at a level consistent with the SNI was more strongly associated with a good surgical outcome. Of the patients with a poor surgical outcome, surgery was most often performed at a level inconsistent with the SNI finding. CONCLUSIONS: Our study found that a diagnostic SNI can safely and accurately discern the presence or absence of cervical or lumbar radiculopathy. The diagnostic SNI can persuade surgeons from operating on an initially suspicious, but incorrect, level of radiculopathy. In cases where MRI findings are equivocal, multilevel, and/or do not agree with the patient's symptoms, the result of a negative diagnostic SNI (ie, lack of presence of radiculopathy) becomes superior in predicting the absence of an offending lesion.