Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial

Philippe Rigoard, Surajit Basu, Mehul Desai, Rod Taylor, Lieven Annemans, Ye Tan, Mary Jo Johnson, Carine Van den Abeele, Richard North, PROMISE Study Group, Philippe Rigoard, Surajit Basu, Mehul Desai, Rod Taylor, Lieven Annemans, Ye Tan, Mary Jo Johnson, Carine Van den Abeele, Richard North, PROMISE Study Group

Abstract

Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP. This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas. If trial stimulation was successful, a multicolumn SCS system was implanted. Outcomes were assessed at baseline (before randomization) and at 1, 3, 6, and 12 months after randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ≥50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability, and health-related quality of life (HRQoL). The results are posted at ClinicalTrials.gov under registration number NCT01697358. In the intent-to-treat analysis, there were more responders in the SCS group than in the OMM group (13.6%, 15/110 vs 4.6%, 5/108, difference 9% with 95% confidence interval 0.6%-17.5%, P = 0.036) at 6 months. The SCS group improved in all secondary outcomes compared with the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention. Adding multicolumn SCS to OMM improved pain relief, HRQoL, and function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.

Conflict of interest statement

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Figures

Figure 1.
Figure 1.
CONSORT diagram of patient flow. OMM, optimal medical management; SCS, spinal cord stimulation.
Figure 2.
Figure 2.
Low back pain intensity, as-treated. OMM, optimal medical management; SCS, spinal cord stimulation.
Figure 3.
Figure 3.
Leg pain intensity, as-treated. OMM, optimal medical management; SCS, spinal cord stimulation.
Figure 4.
Figure 4.
Oswestry Disability Index, as-treated. ODI, Oswestry Disability Index; OMM, optimal medical management; SCS, spinal cord stimulation.

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