Pain outcomes stratified by treatment group
| Study time point | Baseline | 1-month follow-up | 3-month follow-up | 6-month follow-up | 9-month follow-up | 12-month follow-up | ||||||||||||
| CRFA (n=96) | Crossover (n=89) | P-value | CRFA (n=95) | Crossover (n=86) | P-value | CRFA (n=87) | Crossover (n=82) | P-value | CRFA (n=75) | Crossover (n=72) | P-value | CRFA (n=62) | Crossover (n=64) | P-value | CRFA (n=61) | Crossover (n=63) | P-value | |
| Average Pain Score (mean, SD) | 6.4 (1.4) | 6.1 (1.5) | 0.15 | 4.1 (2.4) | 3.3 (2.2) | 0.03 | 3.9 (2.4) | 3.3 (2.6) | 0.17 | 3.6 (2.4) | 3.6 (2.5) | 0.96 | 4.0 (2.6) | 3.1 (2.2) | 0.06 | 3.5 (2.6) | 3.4 (2.5) | 0.76 |
| Change from baseline in average pain (mean, SD)* | – | – | – | 2.3 (2.1) | 2.8 (2.6) | 0.28 <0.0001 | 2.5 (2.2) | 2.8 (2.9) | 0.42 <0.0001 | 2.7 (2.2) | 2.5 (3.0) | 0.51 <0.0001 | 2.3 (2.4) | 2.9 (2.6) | 0.19 <0.0001 | 2.7 (2.5) | 2.6 (2.8) | 0.79 <0.0001 |
| Worst Pain Score (mean, SD) | 8.6 (1.2) | 8.1 (1.4) | 0.01 | 6.1 (3.0) | 5 (2.9) | 0.01 | 6 (2.9) | 5.2 (3.3) | 0.10 | 5.5 (3.1) | 5.5 (3.2) | 0.95 | 5.7 (3.3) | 5.2 (2.8) | 0.23 | 5.5 (3.2) | 5.3 (3.0) | 0.69 |
| Change from baseline in worst pain (mean, SD)* | – | – | – | 2.3 (2.9) | 3.0 (3.0) | 0.06 <0.0001 | 2.3 (2.8) | 2.9 (3.2) | 0.04 <0.0001 | 2.8 (3.0) | 2.5 (3.3) | 0.41 <0.0001 | 2.6 (3.2) | 2.7 (3.0) | 0.53 <0.0001 | 2.7 (3.1) | 2.7 (3.1) | 0.78 <0.0001 |
| Responder analyses † | ||||||||||||||||||
| ≥30% Improvement in average pain (N, %) | – | – | – | 48 (50.5) | 50 (58.1) | 0.30 | 45 (51.7) | 49 (59.8) | 0.29 | 49 (65.3) | 36 (50.0) | 0.06 | 31 (50.0) | 39 (60.9) | 0.22 | 36 (59.0) | 39 (61.9) | 0.74 |
| ≥50% Improvement in average pain (N, %) | – | – | – | 38 (40.0) | 41 (47.7) | 0.30 | 35 (40.2) | 45 (54.9) | 0.06 | 34 (45.3) | 30 (41.7) | 0.65 | 21 (33.9) | 34 (53.1) | 0.03 | 25 (41.0) | 29 (46.0) | 0.57 |
| At least a 2-point decrease in average pain (N, %) | – | – | – | 51 (53.7) | 54 (62.8) | 0.22 | 54 (62.1) | 52 (63.4) | 0.86 | 52 (69.3) | 45 (62.5) | 0.38 | 38 (61.3) | 43 (67.2) | 0.49 | 43 (70.5) | 41 (65.1) | 0.52 |
| Positive responder (N, %)† | – | – | – | 39 (41.1) | 45 (52.3) | 0.13 | 45 (51.7) | 49 (59.8) | 0.29 | 41 (54.7) | 37 (51.4) | 0.69 | 32 (51.6) | 37 (58.7) | 0.42 | 35 (57.4) | 35 (55.6) | 0.84 |
*Top p-value represents the difference between CRFA group as initial treatment and crossover CRFA group, while the bottom p-value represents the change from baseline for the entire cohort. When only a single p-value is listed, it represents the difference between the CRFA group as an initial treatment and the crossover CRFA group.
†Positive responder is defined as (1) at least a 2-point or 30% reduction in average NRS pain from baseline and (2) a rating of at least 5 on the Patient Global Impression of Change.
CRFA, cooled radiofrequency ablation.