TABLE 4.
Primary and Secondary Outcomes: Fixed-effect NMA Results
Mean percentage reduction from baseline back pain VAS/NRS score | ||
---|---|---|
Mean difference (95% CrI): % | ||
Comparison* | 3 mo† | 6 mo‡ |
Closed-loop SCS vs. Fixed-output SCS | 26.38 (8.18-44.59) | 32.72 (15.69-49.78) |
Fixed-output SCS vs. CMM | 74.34 (66.62-82.06) | 68.86 (63.43-74.31) |
Closed-loop SCS vs. CMM | 100.72 (80.92-120.51) | 101.58 (83.73-119.48) |
Proportion of patients with 50% and 80% reduction from baseline back pain VAS/NRS score at 6 mo | ||
Risk Difference (95% CrI) | ||
Comparison§ | 50% reduction‡ | 80% reduction‡,∥ |
Closed-loop SCS vs. fixed-output SCS | 0.46 (0.21-0.71) | 0.29 (0.05-0.53) |
Fixed-output SCS vs. CMM | 0.78 (0.72-0.85) | 0.48 (0.40-0.56) |
Closed-loop SCS vs. CMM | 1.24 (0.98-1.50) | 0.77 (0.52-1.02) |
Proportion of patients with ≥10-point reduction in ODI score (ODI responders) from baseline | ||
Risk Difference (95% CrI) | ||
Comparison§ | 3 mo† | 6 mo‡ |
Closed-loop SCS vs Fixed-output SCS | 0.36 (0.13-0.58) | 0.37 (0.14-0.61) |
Fixed-output SCS vs CMM | 0.69 (0.57-0.81) | 0.75 (0.68-0.82) |
Closed-loop SCS vs CMM | 1.05 (0.79-1.30) | 1.12 (0.87-1.37) |
Mean change from baseline in ODI | ||
Mean difference (95% CrI) | ||
Comparison* | ODI (6 mo)¶ | |
Closed-loop SCS vs. fixed-output SCS | 14.48 (5.97-23.03) | |
Fixed-output SCS vs. CMM | 28.68 (24.06-33.29) | |
Closed-loop SCS vs. CMM | 43.15 (33.47-52.84) | |
Mean change from baseline in EQ-5D-5L Index score | ||
Mean difference (95% CrI) | ||
Comparison* | 3 mo† | 6 mo# |
Closed-loop SCS vs. fixed-output SCS | 0.07 (−0.03 to 0.18) | 0.12 (0.02-0.22) |
Fixed-output SCS vs. CMM | 0.20 (0.16-0.25) | 0.24 (0.20-0.29) |
Closed-loop SCS vs. CMM | 0.28 (0.17-0.39) | 0.36 (0.25-0.47) |
Mean difference >0 favors the first intervention in the comparison over the second intervention.
EVOKE NSRBP subgroup with LVCF (n=50) and completers from SENZA-NSRBP (n=143).
EVOKE NSRBP subgroup with LVCF (n=48) and completers from SENZA-NSRBP (n=140) and DISTINCT (n=183).
Risk difference > 0 favors the first intervention in the comparison over the second intervention.
Convergence problems occurred due to very low numbers of patients (0 to 1) achieving ≥80% pain reduction in CMM group of SENZA-NSRBP and DISTINCT.
Evoke NSRBP subgroup with LVCF (n=48) and completers from DISTINCT (n=183).
Evoke NSRBP subgroup with LVCF (n=48) and completers from SENZA-NSRBP (n=140).
CMM indicates conventional medical management; CrI, Credible interval; NMA, network meta-analysis; NRS, numeric rating scale; ODI, Oswestry Disability Index; SCS, spinal cord stimulation; VAS, visual analog scale.