This notice describes corrections to the Online First version of “Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation: The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial.”
The Anesthesiology editorial staff have become aware that one of the coprimary endpoints was ambiguously described in the original version of the manuscript. Specifically, the coprimary endpoint for outcome of facet and medial branch blocks used by the authors was the change in numerical pain rating at 1 month rather than the numerical pain rating score itself. While the interpretation of the data and conclusions have not changed, several elements of the manuscript have been updated.
Specifically:
The last line of the methods section in the Abstract read: “Coprimary outcome measures were average numerical rating scale pain scores 1 month after the facet or saline blocks and 3 months after ablation.”
It now reads: “Coprimary outcome measures were average reduction in numerical rating scale pain score 1 month after the facet or saline blocks, and average numerical rating scale pain score 3 months after ablation.”
The first sentence in the second paragraph under the heading “Data Collection” read: “For the facet phase of the study, the primary outcome measure was average 0 to 10 numerical rating scale pain score (10 cm written pain scale showing all integers) 1 month after the facet injection.”
It now reads: “For the facet phase of the study, the primary outcome measure was average reduction in 0 to 10 numerical rating scale pain score (10 cm written pain scale showing all integers) 1 month after the facet injection.”
The second sentence in the second paragraph under the heading “Statistical Analysis” read: “The coprimary outcomes of difference in numerical rating scale pain score at 1 month after facet injection and 3 months after radiofrequency ablation among the three treatment/control groups were evaluated with an ANOVA.”
It now reads: “The coprimary outcomes of mean reduction in numerical rating scale pain score at 1 month after facet injection and average pain score 3 months after radiofrequency ablation were compared in the three treatment/control groups using an ANOVA.”
The second sentence under the heading “3-month Radiofrequency Coprimary Outcome Measure and Follow-ups” read: “The mean reduction in average numerical rating scale pain score 1 month after ablation was 2.2 ± 2.1 (95% CI, 1.6 to 2.8) in the intraarticular group, 2.1 ± 2.0 (95% CI, 1.5 to 2.7) in the medial branch block group, and 1.0 ± 1.6 (95% CI, 0.5 to 1.5) in the control group (P = 0.986 for
intraarticular vs. medial branch block group, P = 0.017 for intraarticular vs. placebo group, P = 0.023 for medial branch block vs. placebo group), with similar reductions in worst numerical rating scale pain score and medication use.”
It now reads: “The average numerical rating scale pain score at 3 months was 3.0 ± 2.0 (95% CI, 2.4 to 3.6) in the intraarticular group, 3.2 ± 2.5 in the medial branch block group (95% CI, 2.5 to 3.9), and 3.5 ± 1.9 (95% CI, 2.9 to 4.1) in the control group (P = 0.860 for intraarticular vs. medial branch block group, P = 0.461 for intraarticular vs. placebo group, P = 0.768 for medial branch block vs. placebo group). The average reduction in numerical rating scale pain score at 3 months was 1.8 ± 2.3 (95% CI, 1.1 to 2.5) in the intraarticular group, 1.8 ± 2.4 in the medial branch block group (95% CI, 1.1 to 2.5), and 0.7 ± 1.5 (95% CI, 0.3 to 1.2) in the control group (P = 0.998 for intraarticular vs. medial branch block group, P = 0.044 for intraarticular vs. placebo group, P = 0.046 for medial branch block vs. placebo group).”
Table 2 has been updated to include Average NRS Pain Score (mean ± SD) and Worst NRS Pain Score (mean ± SD).
The legend in Table 4 has been updated to provide explanation to the data.
