Sayed D, Grider J, Strand N, et al. J Pain Res. 2022;15:3729-3832.
The authors have advised that there is an error in Table 32 on page 3797. Row six Gilligan et al 2021, fourth column level of evidence, the text “I-C” should read “I-A”. The correct Table 32 is as follows.
Table 32.
Evidence Summary for Multifidus Activation via Medial Branch Nerve Stimulation
| Source, Year | Design | Sample Size | Level of Evidence | Outcome Measures | Results |
|---|---|---|---|---|---|
| Deckers et al, 2018336 | Prospective, multi-center, single-arm, non-randomized trial | 53 | I-B | NRS (back), ODI, EQ-5D | The percentage of subjects at 90 days, 6 months, and 1 year with greater than or equal to MCID in single day NRS was 63%, 61%, and 57% respectively. The percentage of subjects with greater than or equal to MCID in EQ-5D was 88%, 82%, and 81% respectively. There were no unanticipated adverse events related to the device, procedure, or therapy. |
| Cohen, et al, 2019337 | Case-series | 9 | II | Daily pain levels and analgesic medication consumption in weekly diaries and once weekly visits to assess pain, disability, and adverse events, ODI, BPI-9, PGIC | At one month, 67% of patients experienced highly clinically significant reductions in average BPI vs baseline. The mean reduction in average pain intensity in all subjects was 59% with average 76% reduction in non-opioids and 100% reduction in opioid, with 67% experiencing significant improvement in ODI and reduction in BPI. |
| Ilfeld et al, 2017338 | Retrospective literature review | 43 | I-C | Rate of infection/1000 indwelling days; Rate of infection in the 1st 30 and 60 days | The risk of infection with non-coiled leads was estimated to be 25 times greater than with coiled leads. The infection rates were estimated to be 0.03 infections per 1000 indwelling days for coiled leads and 0.83 infections per 1000 indwelling days for non-coiled leads. |
| Gilligan et al, 2021339 | Randomized, multi-center, active- sham-controlled clinical trial | 204 | I-A | Comparison of responder subjects with greater than or equal to 30% relief on VAS (LBP) without analgesic increase at 120 days; ODI, EQ-5D, PPR, PGIC, and LBP resolution | The primary endpoint comparing the responder proportions was inconclusive in superiority; however, prespecified secondary outcomes and analyses were consistent with a modest but clinically significant meaningful treatment benefit at 120 days. |
| Gilligan et al, 2021340 | Open-label follow up of randomized, active-sham-controlled trial | 204 | I-A | VAS, ODI, EQ-5D-5L, opioid intake at 6, 12, and 24 months | At two years, 76% subjects experienced ≥50% CLBP relief and 65% reported CLBP resolution; 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. |
| Kapural et al, 2018341 | Case report | 2 | II | BPI, ODI | 2 subjects experienced clinically significant reductions in average BPI at end of therapy, which was sustained at 4 months with at least 50% reduction in ODI and 83% reduction in BPI, revealing the utility of minimally invasive neuromodulation therapy |
| Gilmore et al, 2019342 | Case Series | 9 | II | BPI-3, BPI-5 | Among responders at four months, the mean reduction in average pain intensity (BPI-5) and worst pain intensity (BPI-3) was 84% and 78%, respectively. Subject-reported reductions in pain intensity were substantiated by concomitant and sustained reductions in analgesic medication usage. Subjects also reported clinically significant reductions in patient-centric outcomes of disability (ODI), pain interference (BPI-9), and PGIC. |
| Thomson et al, 2021539 | Post-market prospective clinical follow-up | 42 | I-B | NRS, ODI, EQ-5D-5L | Among the 37 patients completing 2-year follow-up, NRS pain scores improved from 7.0 ± to 3.5 ± 0.3, ODI scores improved from 46.2 ± 2.2 to 29.2 ± 3.1, and health-related quality of life improved from 0.426 ± 0.035 to 0.675 ± 0.030. Additionally, 57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements. |
Abbreviations: NRS, numeric rating scale; ODI, Oswestry Disability Index; EQ-5D, EuroQOL health questionnaire; MCID, minimum clinically important difference; BPI, Brief Pain Inventory; PGIC, patient global impression of change; VAS, visual analog scale; PPR, percentage pain relief; LBP, low back pain.
The authors apologize for this error.