PT  - JOURNAL ARTICLE
AU  - FISCHGRUND, JEFFREY S.
AU  - RHYNE, ALFRED
AU  - FRANKE, JÖRG
AU  - SASSO, RICK
AU  - KITCHEL, SCOTT
AU  - BAE, HYUN
AU  - YEUNG, CHRISTOPHER
AU  - TRUUMEES, EERIC
AU  - SCHAUFELE, MICHAEL
AU  - YUAN, PHILIP
AU  - VAJKOCZY, PETER
AU  - DEPALMA, MICHAEL
AU  - ANDERSON, DAVID G.
AU  - THIBODEAU, LEE
AU  - MEYER, BERNHARD
TI  - Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
AID  - 10.14444/6015
DP  - 2019 Apr 01
TA  - International Journal of Spine Surgery
PG  - 110--119
VI  - 13
IP  - 2
4099  - https://www.ijssurgery.com/content/13/2/110.short
4100  - https://www.ijssurgery.com/content/13/2/110.full
SO  - Int J Spine Surg2019 Apr 01; 13
AB  - 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.