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.,European Spine Journal

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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.
European Spine Journal ( IF 2.8 ) Pub Date : 2020-05-25 , DOI: 10.1007/s00586-020-06448-x
Jeffrey S Fischgrund ₁ , Alfred Rhyne ₂ , Kevin Macadaeg ₃ , Gregory Moore ₄ , Evish Kamrava ₅ , Christopher Yeung ₆ , Eeric Truumees ₇ , Michael Schaufele ₈ , Philip Yuan ₉ , Michael DePalma ₁₀ , David Greg Anderson ₁₁ , Douglas Buxton ₁₂ , James Reynolds ₁₃ , Michael Sikorsky ₁₄

Affiliation

William Beaumont Hospital, Oakland University School of Medicine, 3601 W 13 Mile Road, Royal Oak, MI, 48073, USA.
OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.
Indiana Spine Group, 13225 North Meridian Street, Carmel, IN, 46032, USA.
Pacific Sports and Spine, 74B Centennial Loop, Suite 300, Eugene, OR, 97401, USA.
The Spine Institute, 2811 Wilshire Boulevard, Suite 850, Santa Monica, CA, 90403, USA.
Desert Institute for Spine Care, 1635 E Myrtle Avenue, Suite 400, Phoenix, AZ, 85020, USA.
Seton Spine & Scoliosis Center, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA.
Drug Studies America, 400 Tower Road NE, Suite 150, Marietta, GA, 30060, USA.
Memorial Orthopedic Surgical Group, Department of Surgery, Long Beach Memorial Medical Center, 2760 Atlantic Avenue, Long Beach, CA, 90806, USA.
Virginia iSpine Physicians, 9020 Stony Point Parkway, S-140, Richmond, VA, 23235, USA.
Rothman Orthopedic Institute, 3300 Tillman Drive, 2nd Floor, Glenview Corporate Center, Bensalem, PA, 19020, USA.
Maine Medical Partners Neurosurgery and Spine, 195 Fore River Parkway, Suite 490, Portland, ME, 04102, USA.
Spine Care Medical Group, 455 Hickey Boulevard, Suite 310, Daly City, CA, 94015, USA.
Michigan Orthopedic Institute, 26025 Lahser Road, Suite 200B, Southfield, MI, 48033, USA.

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.

中文翻译：

骨内基底椎神经消融治疗慢性腰痛的长期结果：一项前瞻性随机双盲假对照多中心研究的 5 年治疗组结果。

背景

受损或退化的椎骨终板是导致椎源性慢性腰痛 (CLBP) 的重要原因。Modic 变化是这些患者的一种客观 MRI 生物标志物。来自假对照治疗组的先前数据，RCT 显示在基底椎神经 (BVN) 消融后 2 年临床改善得以维持。本研究报告了 5 年的临床结果。

方法

总共有 117 名美国患者成功接受了 BVN 消融治疗。在 BVN 消融后至少 5 年收集患者报告的 ODI、VAS、消融后治疗和患者满意度的结果。主要结果是 ODI 的平均变化。使用α 0.05 的协方差分析对消融后值和基线值进行比较。

结果

在美国接受治疗的 117 名患者中，有 100 名 (85%) 可供审查，平均随访时间为 6.4 年（5.4-7.8 年）。5 年随访时平均 ODI 评分从 42.81 提高到 16.86，降低了 25.95 分（p < 0.001）。VAS 疼痛评分的平均降低为 4.38 分（基线为 6.74，p < 0.001）。总共有 66% 的患者报告疼痛减轻 > 50%，47% 报告疼痛减轻 > 75%，34% 的患者报告疼痛完全缓解。5 年时使用≥ 15 点 ODI 和≥ 2 点 VAS 阈值的功能和疼痛复合反应率为 75%。