Khalil Jad G, Truumees Eeric, Macadaeg Kevin, Nguyen Daniel T D, Moore Gregory A, Lukes Dylan, Fischgrund Jeffrey
Orthopaedic Surgery, Oakland University, William Beaumont School of Medicine, Department of Orthopaedic Surgery, Beaumont University Hospital, 3811 West 13 Mile Rd, Royal Oak, MI, 48073, USA.
Orthopaedic and Neurological Surgery, University of Texas, Dell Medical School, Ascension Spine & Scoliosis Center, Ascension Seton Medical Center, 1004 West 32nd Street #200, Austin, TX, 78705, USA.
Interv Pain Med. 2024 Dec 13;3(4):100529. doi: 10.1016/j.inpm.2024.100529. eCollection 2024 Dec.
Vertebrogenic pain is a documented source of anterior column chronic low back pain (CLBP) that stems from damaged vertebral endplates. Nociceptive signals are transmitted by the basivertebral nerve (BVN) and endplate damage is observed as Type 1 or Type 2 Modic changes (MC) on magnetic resonance imaging (MRI). The clinical impact and safety of intraosseous radiofrequency ablation of the BVN (BVNA) for the treatment of vertebrogenic pain has been demonstrated in three prospective clinical trials (two randomized and one single-arm study).
Report aggregate long-term BVNA outcomes at five years from three studies.
Pooled results at 5-years post-BVNA are reported for three clinical trials with similar inclusion/exclusion criteria and outcomes measurements: 1) a prospective, open label, single-arm follow-up of the treatment arm of a randomized controlled trial (RCT) comparing BVNA to sham ablation (SMART); 2) a prospective, open label, single-arm follow-up of the treatment arm of an RCT comparing BVNA to standard care (INTRACEPT); and 3) a prospective, open label, single-arm long-term follow-up study of BVNA-treated participants (CLBP Single-Arm). Paired datasets (baseline and 5-years) for mean changes in Oswestry disability index (ODI) and numeric pain scores (NPS) were analyzed using a two-sided paired -test with a 0.05 level of significance. Secondary outcomes included responder rates, patient satisfaction, adverse events, and healthcare utilization.
Two hundred forty-nine (249) of 320 BVNA-treated participants (78 % participation rate) completed a five-year visit (mean of 5.6 years follow-up). At baseline, 71.9 % of these participants reported back pain for ≥5 years, 27.7 % were taking opioids, and 61.8 % had prior therapeutic lumbar spinal injections. Pain and functional improvements were significant at 5-years with a mean improvement in NPS of 4.32 ± 2.45 points (95 % CI 4.01, 4.63; p < 0.0001) from 6.79 ± 1.32 at baseline and a mean improvement in ODI of 28.0 ± 17.5 (95 % CI 25.8, 30.2; p < 0.0001) from 44.5 ± 11.0 at baseline. Nearly one-third (32.1 %) of patients reported being pain-free (NPS = 0) at five years, 72.7 % of patients indicated their condition improved and 68.7 % had resumed activity levels they had prior to onset of CLBP. In the sixty-nine participants taking opioids at baseline, 65.2 % were no longer taking them at 5-years, and spinal injections decreased by 58.1 %. The rate of lumbosacral treatment (therapeutic spinal injection, radiofrequency ablation, or surgery) for the same index pain source and vertebral level was 33/249 (13.2 %) at 5 years post BVNA; including a 6.0 % rate of lumbar fusion. There were no serious device or device-procedure related adverse events reported during the long-term follow-up.
In this 5-year aggregate analysis, BVNA significantly improved pain and function scores compared to baseline. Similarly, there were significant reductions in opioid consumption and spinal injections post BVNA. Data demonstrate a strong safety profile with no serious device or device-related events and low healthcare utilization rate for the same index pain source through a mean of 5.6 years. Results demonstrate that intraosseous BVNA treatment for patients with vertebrogenic pain is safe, effective, and durable through five years.
椎源性疼痛是前柱慢性下腰痛（CLBP）的一个已被证实的来源，其源于受损的椎体终板。伤害性信号通过椎基静脉神经（BVN）传递，在磁共振成像（MRI）上，终板损伤表现为1型或2型Modic改变（MC）。三项前瞻性临床试验（两项随机试验和一项单臂研究）已证明了骨内射频消融BVN（BVNA）治疗椎源性疼痛的临床效果和安全性。
报告三项研究中BVNA五年的总体长期结果。
报告了三项临床试验BVNA术后5年的汇总结果，这些试验具有相似的纳入/排除标准和结果测量方法：1）一项随机对照试验（RCT）治疗组的前瞻性、开放标签、单臂随访，该试验将BVNA与假消融（SMART）进行比较；2）一项RCT治疗组的前瞻性、开放标签、单臂随访，该试验将BVNA与标准护理（INTRACEPT）进行比较；3）一项对接受BVNA治疗参与者的前瞻性、开放标签、单臂长期随访研究（CLBP单臂研究）。使用双侧配对t检验分析Oswestry功能障碍指数（ODI）和数字疼痛评分（NPS）平均变化的配对数据集（基线和5年），显著性水平为0.05。次要结果包括缓解率、患者满意度、不良事件和医疗保健利用率。
320名接受BVNA治疗的参与者中有249名（参与率78%）完成了五年随访（平均随访5.6年）。基线时，这些参与者中有71.9%报告背痛≥5年，27.7%正在服用阿片类药物，61.8%曾接受过治疗性腰椎注射。5年时疼痛和功能有显著改善，NPS从基线时的6.79±1.32分平均改善4.32±2.45分（95%CI 4.01，4.63；p<0.0001），ODI从基线时的44.5±11.0分平均改善28.0±17.5（95%CI 25.8，3 .2；p<0.0001）。近三分之一（32.1%）的患者在五年时报告无痛（NPS=0），72.7%的患者表示病情有所改善，68.7%的患者恢复到CLBP发作前的活动水平。在基线时服用阿片类药物的69名参与者中，65.2%在五年时不再服用，脊柱注射减少了58.1%。BVNA术后5年，同一索引疼痛源和椎体水平的腰骶部治疗（治疗性脊柱注射、射频消融或手术）率为33/249（13.2%）；包括6.0%的腰椎融合率。长期随访期间未报告严重的器械或器械相关不良事件。
在这项5年的汇总分析中，与基线相比，BVNA显著改善了疼痛和功能评分。同样，BVNA术后阿片类药物消费和脊柱注射也显著减少。数据显示，在平均5.6年的时间里，针对同一索引疼痛源，BVNA具有良好的安全性，没有严重的器械或器械相关事件，医疗保健利用率低。结果表明，骨内BVNA治疗椎源性疼痛患者在五年内是安全、有效且持久的。
