TABLE 3.

Outcomes of Randomized Controlled Trials Included in the Systematic Review

References	Intervention	Control	Outcomes included in the analysis at 6 mo	Key findings	Adverse events at last follow-up	Explants at last follow-up
Deer et al17 DISTINCT	B-SCS (fixed-output SCS)	CMM	Percent pain reduction from baseline Proportion of patients with ≥50% pain reduction Proportion of patients with ≥80% pain reduction Change in ODI Proportion of patients with MCID ≥10 in ODI Proportion of patients reporting “better or a great deal better” in PGIC	↑ P<0.001 ↑ P<0.001 B-SCS 42.2%/CMM 1.2% ↑ P<0.001 B-SCS 91.2%/CMM 16.0% ↑ P<0.001	Fourteen nonserious device- or procedure-related events were reported in the B-SCS arm (14/162, 8.6%), of which 6 lead migrations (3.7%), 2 infections (1.2%), 2 skin reactions, 2 IPG pocket pain, 1 CSF leakage, and 1 IPG migration. Three SAEs were reported, of which 2 were infections that required explant, 1 was postprocedural abdominal pain resolved with pain management without sequelae	At 6 mo there were 2 explants due to infections; no explants reported due to LoE
Kapural et al15 SENZA-NSRBP	HF-SCS (fixed-output SCS)	CMM	Percent pain reduction from baseline Proportion of patients with ≥50% pain reduction Proportion of patients with ≥80% pain reduction Proportion of patients with MCID ≥10 in ODI Change in HRQoL (EQ-5D utility) Proportion of patients reporting “better or a great deal better” in PGIC	↑ P<0.001 ↑ P<0.001 HF-SCS 58.5%/CMM 0% ↑ P<0.001 ↑ P<0.001 ↑ P<0.001	At 12 mo there were 5 SAEs (2 implant site infections, 1 poor wound healing, 1 lethargy, 1 osteomyelitis). Over 24 mo, there were 51 study-related AEs.32 The most common AE was implant site pain (13 events in 12/145 patients [8.3%]; 8 [5.5%] required IPG repositioning. Implant site infection was reported by 6 patients (4.1%), and 3 patients (2%) had transient CSF leakage. Six patients (4.1%) underwent lead revision due to lead dislodgment	Over 24 mo there were 6 (4.8%) explants out of 125 SCS devices.(32) Three (2.4%) were due to patient dissatisfaction with SCS therapy (inefficacy, LoE), and 3 (2.4%) due to infection (2 of these patients received a replacement device)
Mekhail et al16 EVOKE NSRBP subgroup	CL-SCS	OL-SCS (fixed-output SCS)	Percent pain reduction from baseline Proportion of patients with ≥50% pain reduction Proportion of patients with ≥80% pain reduction Change in ODI Proportion of patients with MCID ≥10 in ODI Change in HRQoL (EQ-5D utility) Proportion of patients reporting “improved or very much improved” in PGIC	↑ P<0.001 ↑ P<0.01 ↑ P<0.05 ↑ P<0.01 ↑ P<0.01 ↑ P<0.001 ↑ P<0.001	At 36 mo there were 7 AEs in 6 (24%) patients in the OL-SCS group and 13 AEs in 8 (32%) patients in the CL-SCS group (rate difference 8.0 [95% CI: −16.8 to 32.8]). Most frequently reported AEs were IPG pocket pain (2 [8%] in OL-SCS group and 3 [12%] in CL-SCS group) and lead migration (2 [8%] in OL-SCS group and 2 [8%] in CL-SCS group)	Over 36 mo there were 5 (10%) explants. 1 (4%) explant due to LoE in OL-SCS, 2 explants due to need for MRI (1 [4%] in OL-SCS and 1 [4%] in CL-SCS), and 2 explants due to subsequent unrelated comorbid conditions (1 [4%] in OL-SCS and 1 [4%] in CL-SCS); no explants reported due to LoE for CL-SCS

(-) no statistically significant differences between groups.

↑ statistically significant between groups in favor of intervention group.

AE indicates adverse event; B-SCS, burst SCS; CL-SCS, closed-loop SCS; CMM, conventional medical management; CSF, cerebrospinal fluid; HF-SCS, high-frequency spinal cord stimulation; HRQoL, health-related quality of life; IPG, implantable pulse generator; LoE, loss of efficacy; MCID, minimal clinical important difference; NSRBP, non-surgical refractory back pain; ODI, Oswestry Disability Index; OL-SCS, open-loop SCS; PGIC, Patient Global Impression of Change; SAE, serious adverse event; SCS, spinal cord stimulation.