Jeffrey S Fischgrund1, Alfred Rhyne2, Kevin Macadaeg3, Gregory Moore4, Evish Kamrava5, Christopher Yeung6, Eeric Truumees7, Michael Schaufele8, Philip Yuan9, Michael DePalma10, David Greg Anderson11, Douglas Buxton12, James Reynolds13, Michael Sikorsky14. 1. William Beaumont Hospital, Oakland University School of Medicine, 3601 W 13 Mile Road, Royal Oak, MI, 48073, USA. jsfischgrund37@gmail.com. 2. OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA. 3. Indiana Spine Group, 13225 North Meridian Street, Carmel, IN, 46032, USA. 4. Pacific Sports and Spine, 74B Centennial Loop, Suite 300, Eugene, OR, 97401, USA. 5. The Spine Institute, 2811 Wilshire Boulevard, Suite 850, Santa Monica, CA, 90403, USA. 6. Desert Institute for Spine Care, 1635 E Myrtle Avenue, Suite 400, Phoenix, AZ, 85020, USA. 7. Seton Spine & Scoliosis Center, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA. 8. Drug Studies America, 400 Tower Road NE, Suite 150, Marietta, GA, 30060, USA. 9. Memorial Orthopedic Surgical Group, Department of Surgery, Long Beach Memorial Medical Center, 2760 Atlantic Avenue, Long Beach, CA, 90806, USA. 10. Virginia iSpine Physicians, 9020 Stony Point Parkway, S-140, Richmond, VA, 23235, USA. 11. Rothman Orthopedic Institute, 3300 Tillman Drive, 2nd Floor, Glenview Corporate Center, Bensalem, PA, 19020, USA. 12. Maine Medical Partners Neurosurgery and Spine, 195 Fore River Parkway, Suite 490, Portland, ME, 04102, USA. 13. Spine Care Medical Group, 455 Hickey Boulevard, Suite 310, Daly City, CA, 94015, USA. 14. Michigan Orthopedic Institute, 26025 Lahser Road, Suite 200B, Southfield, MI, 48033, USA.
Abstract
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.
RCT Entities:
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.
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