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With regard to the article in the January 2023 issue, “Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction” (Neuromodulation 2023;26(1):98-108), the authors conducted an additional review of the statistical methods used to account for missing data and an error in the imputation model for repeated binary endpoints was discovered. This error affects the responder rate estimates with imputation for missing data (N = 204) reported in Table 1 and Figure 4. Every test reported as statistically significant remains statistically significant and p values remain unchanged. All other results, descriptions, and clinical interpretations are not affected and remain unchanged. See the following for the revised Table 1 (changes in bold) and Figure 4. The authors regret the error.
FigureResponder proportions at common clinical importance thresholds. a. ≥ 50% VAS reduction and residual VAS ≤ 2.5 cm. b. ≥ 20-point ODI reduction and composite of ≥ 50% VAS reduction and/or ≥ 20-point ODI reduction. Solid lines represent completed cases; dashed lines represent results with MI for missing data (N = 204).
For continuous outcomes, P < 0.0001 for two-sided t-test if the change from baseline differs from 0.
N = 204
N = 176
N = 204
N = 156
N = 204
N = 133
N = 204
LBP VAS (cm)
7.3 ± 0.7
3.0 (0.2)
3.3 (0.2)
2.4 (0.2)
3.1 (0.2)
2.4 (0.2)
3.2 (0.2)
Change in VAS (cm)
−4.3 (0.2) (−4.7, −3.9)
−3.9 (0.2) (−4.3, −3.6)
−4.8 (0.2) (−5.2, −4.5)
−4.2 (0.2) (−4.6, −3.8)
−4.9 (0.2) (−5.3, −4.5)
−4.0 (0.2) (−4.4, −3.6)
Change in VAS (%)
−58.9 (2.6) (−64.1, −53.6)
−54.2 (2.7) (−59.5, −49.0)
−66.7 (2.6) (−71.7, −61.6)
−58.0 (2.7) (−63.3, −52.7)
−67.4 (2.6) (−73.1, −61.6)
−55.6 (2.8) (−61.1, −50.1)
≥ 30% improvement in VAS
73.9 (130/176) (67.4, 80.4)
68.2 (3.4) (61.2, 74.4)
82.6 (128/155) (76.6, 88.6)
72.2 (3.3) (65.2, 78.2)
82.3 (107/130) (75.7, 88.9)
67.7 (3.6) (60.3, 74.3)
≥ 50% improvement in VAS
63.6 (112/176) (56.5, 70.7)
58.7 (3.6) (51.6, 65.5)
71.6 (111/155) (64.5, 78.7)
62.3 (3.6) (55.1, 69.0)
76.9 (100/130) (69.7, 84.2)
63.1 (3.7) (55.6, 70.0)
≥ 70% improvement in VAS
46.6 (82/176) (39.2, 54.0)
43.2 (3.6) (36.4, 50.3)
61.9 (96/155) (54.3, 69.6)
53.4 (3.7) (46.1, 60.5)
61.5 (80/130) (53.2, 69.9)
50.7 (3.8) (43.3, 58.1)
LBP resolution (VAS ≤ 2.5 cm)
51.7 (91/176) (44.3, 59.1)
48.0 (3.6) (41.0, 55.0)
66.5 (103/155) (59.0, 73.9)
57.3 (3.6) (50.0, 64.2)
66.9 (87/130) (58.8, 75.0)
55.0 (3.8) (47.5, 62.3)
ODI
39.1 ± 10.3
19.0 (1.4)
20.6 (1.0)
17.6 (1.2)
20.1 (1.1)
16.4 (1.3)
20.1 (1.1)
Change in ODI
−19.9 (1.2) (−22.3, −17.6)
−18.4 (1.0) (−20.4, −16.3)
−21.4 (1.3) (−24.0, −18.7)
−18.9 (1.1) (−21.0, −16.8)
−22.7 (1.3) (−25.3, −20.1)
−18.9 (1.1) (−21.1, −16.8)
Change in ODI (%)
−50.5 (2.9) (−56.3, −44.8)
−46.4 (2.8) (−51.8, −41.0)
−54.3 (3.2) (−60.6, −48.0)
−47.5 (2.8) (−53.0, −42.0)
−58.5 (3.0) (−64.5, −52.6)
−48.4 (2.9) (−54.0, −42.8)
≥ 20 points improvement in ODI
57.4 (101/176) (50.1, 64.7)
53.5 (3.6) (46.5, 60.5)
61.3 (95/155) (53.6, 69.0)
54.5 (3.6) (47.3, 61.5)
62.6 (82/131) (54.3, 70.9)
52.0 (3.7) (44.7, 59.3)
Composite of VAS and ODI
≥ 50% improvement in VAS and/or ≥ 20 points ODI
73.3 (129/176) (66.8, 79.8)
67.9 (3.4) (60.9, 74.1)
77.3 (119/154) (70.7, 83.9)
67.7 (3.5) (60.5, 74.0)
83.2 (109/131) (76.8, 89.6)
68.7 (3.5) (61.4, 75.2)
≥ 50% improvement in VAS and ≥ 20 points ODI
47.7 (84/176) (40.3, 55.1)
44.1 (36) (37.3, 51.2)
56.5 (87/154) (48.7, 64.3)
49.4 (3.7) (42.3, 56.6)
56.2 (73/130) (47.6, 64.7)
46.2 (3.8) (38.9, 53.6)
EQ-5D-5L index
0.585 ± 0.174
0.780 (0.012)
0.763 (0.012)
0.769 (0.012)
0.768 (0.011)
0.805 (0.014)
0.764 (0.012)
Change in EQ-5D-5L index
0.198 (0.016) (0.167, 0.229)
0.177 (0.011) (0.155, 0.199)
0.218 (0.017) (0.184, 0.253)
0.183 (0.011) (0.160, 0.205)
0.220 (0.017) (0.186, 0.253)
0.178 (0.012) (0.156, 0.201)
PPR (%)
65.7 (2.4) (60.9, 70.5)
60.7 (2.5) (55.7, 65.7)
72.1 (2.4) (67.3, 77.0)
62.3 (2.6) (57.3, 67.3)
75.3 (2.4) (70.6, 80.1)
62.2 (2.6) (57.0, 67.3)
SGIC “Better” or “Much better”
71.6 (126/176) (64.9, 78.3)
66.4 (3.4) (59.4, 72.8)
78.6 (121/154) (72.1, 85.1)
68.8 (3.4) (61.8, 75.1)
80.0 (104/130) (73.1, 86.9)
66.0 (3.6) (58.6, 72.7)
TSQ “Definitely satisfied”
78.2 (136/174) (72.0, 84.3)
73.6 (3.2) (66.7, 79.4)
80.0 (124/155) (73.7, 86.3)
71.2 (3.4) (64.1, 77.3)
85.5 (112/131) (80.4, 92.2)
72.0 (3.4) (64.8, 78.2)
CGI “Much better”
73.3 (129/176) (66.8, 79.8)
68.7 (3.4) (61.8, 74.9)
77.6 (118/152) (71.7, 84.3)
69.5 (3.4) (62.4, 75.8)
81.4 (105/129) (74.7, 88.1)
68.2 (3.6) (60.8, 74.8)
Baseline carried forward for participants who withdrew because of lack of efficacy or explant because of infection. For remaining missing data, continuous outcome estimates from mixed model repeated measures regression models adjusted for baseline; all other binary outcomes analyzed with MI. Statistics are expressed as % (n/N) for binary outcomes and N, mean (standard error) for continuous outcomes.
The imputation model estimates for years 1 and 2 also consider year 3 data and therefore differ slightly from those reported in earlier publications.
∗ For continuous outcomes, P < 0.0001 for two-sided t-test if the change from baseline differs from 0.
Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability.
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