Jeffrey S Fischgrund1, Alfred Rhyne2, Jörg Franke3, Rick Sasso4, Scott Kitchel5, Hyun Bae6, Christopher Yeung7, Eeric Truumees8, Michael Schaufele9, Philip Yuan10, Peter Vajkoczy11, Michael Depalma12, David G Anderson13, Lee Thibodeau14, Bernhard Meyer15. 1. Department of Orthopedic Surgery, Oakland University, William Beaumont School of Medicine, Royal Oak, Michigan. 2. OrthoCarolina Spine Center, Charlotte, North Carolina. 3. Department of Orthopedics-Spine and Pediatric Orthopedics, Klinikum Magdeburg gGmbH, Magdeburg, Germany. 4. Department of Orthopedic Surgery, Indiana University School of Medicine, Indianapolis, Indiana. 5. NeuroSpine Institute, Eugene, Oregon. 6. Department of Surgery, Cedars Sinai Medical Center, Los Angeles, California. 7. Desert Institute for Spine Care, Phoenix, Arizona. 8. Seton Brain & Spine Institute, Department of Surgery, Dell Medical School, Seton Spine & Scoliosis Center, Austin, Texas. 9. Pain Solutions Treatment Centers, Marietta, Georgia. 10. Department of Surgery, Long Beach Memorial Medical Center, Long Beach, California. 11. Department of Neurosugery, Charité Universitätsmedizin, Berlin Campus, Virchow Medical Center, Berlin, Germany. 12. Virginia iSpine Physicians, Richmond, Virginia. 13. Department of Orthopaedic and Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania. 14. Maine Spine Surgery, Portland, Maine. 15. Direktor der Neurochirurgische Klinik und Poliklinik, Technischen Universität München, Klinikum rechts der Isar, Munich, Germany.
Abstract
BACKGROUND: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. METHODS: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. RESULTS: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. CONCLUSIONS: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.
BACKGROUND: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. METHODS: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. RESULTS: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. CONCLUSIONS: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.
Entities:
Keywords:
basivertebral nerve; chronic low back pain; radiofrequency ablation
Authors: Andrew Fagan; Robert Moore; Barrie Vernon Roberts; Peter Blumbergs; Robert Fraser Journal: Spine (Phila Pa 1976) Date: 2003-12-01 Impact factor: 3.468
Authors: D G Borenstein; J W O'Mara; S D Boden; W C Lauerman; A Jacobson; C Platenberg; D Schellinger; S W Wiesel Journal: J Bone Joint Surg Am Date: 2001-09 Impact factor: 5.284
Authors: Aaron Conger; Matthew Smuck; Eeric Truumees; Jeffrey C Lotz; Michael J DePalma; Zachary L McCormick Journal: Pain Med Date: 2022-07-20 Impact factor: 3.637
Authors: Zachary L McCormick; Beau P Sperry; Barret S Boody; Joshua A Hirsch; Aaron Conger; Katrina Harper; Jeffrey C Lotz; Taylor R Burnham Journal: Pain Med Date: 2022-07-20 Impact factor: 3.637
Authors: Ivan Urits; Nazir Noor; Arjun Singh Johal; Joseph Leider; Joseph Brinkman; Nathan Fackler; Neeraj Vij; Daniel An; Elyse M Cornett; Alan D Kaye; Omar Viswanath Journal: Pain Ther Date: 2020-10-31
Authors: Vinicius Tieppo Francio; David Sherwood; Eric Twohey; Brandon Barndt; Robert Pagan-Rosado; James Eubanks; Dawood Sayed Journal: J Pain Res Date: 2021-06-23 Impact factor: 3.133