Fig. 1.

CONSORT Diagram, In the INTRACEPT RCT 140 participants were randomized when enrollment was stopped due to statistical superiority at the interim analysis, with sixty-six (66) randomized to BVNA. Fifty-three of these 66 consented to a long-term follow-up study (80% retention rate) and completed a 24-month and 3-year follow-up visits. In the prospective single arm cohort study, 47 participants were treated with BVNA. Of these, 42 consented to a long-term follow-up study (89% retention rate) and had a 3-year follow-up visit. Details on reasons for study exit prior to the 3-year visit are reported for this aggregate study within the CONSORT diagram below. Abbreviations: BVNA - basivertebral nerve ablation; CLBP - chronic low back pain; LTFU - lost to follow-up; RCT - randomized controlled trial.