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

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) fa...

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Veröffentlicht in:	Pain (Amsterdam) Jg. 160; H. 6; S. 1410
Hauptverfasser:	Rigoard, Philippe, Basu, Surajit, Desai, Mehul, Taylor, Rod, Annemans, Lieven, Tan, Ye, Johnson, Mary Jo, Van den Abeele, Carine, North, Richard
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.06.2019
Schlagworte:	Adult Back Pain - complications Back Pain - therapy Failed Back Surgery Syndrome - therapy Female Humans Low Back Pain - complications Low Back Pain - therapy Male Middle Aged Neuralgia - etiology Neuralgia - therapy Neurosurgical Procedures - adverse effects Pain Management Pain Measurement - methods Prospective Studies Quality of Life Spinal Cord Stimulation - methods
ISSN:	1872-6623, 1872-6623
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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.
AbstractList	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. 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.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.
Author	North, Richard Annemans, Lieven Basu, Surajit Desai, Mehul Tan, Ye Rigoard, Philippe Johnson, Mary Jo Taylor, Rod Van den Abeele, Carine
Author_xml	– sequence: 1 givenname: Philippe surname: Rigoard fullname: Rigoard, Philippe organization: UMR 3346, CNRS, P' Institute, Futuroscope, Poitiers, France – sequence: 2 givenname: Surajit surname: Basu fullname: Basu, Surajit organization: Department of Neurosurgery, Nottingham University Hospital, Nottingham, United Kingdom – sequence: 3 givenname: Mehul surname: Desai fullname: Desai, Mehul organization: George Washington University Medical Center, Washington, DC, United States – sequence: 4 givenname: Rod surname: Taylor fullname: Taylor, Rod organization: Institute of Health Research, University of Exeter Medical School, Exeter, United Kingdom – sequence: 5 givenname: Lieven surname: Annemans fullname: Annemans, Lieven organization: Interuniversity Centre for Health Economics Research, Ghent University, Brussels University, Ghent and Brussels, Belgium – sequence: 6 givenname: Ye surname: Tan fullname: Tan, Ye organization: Department of Clinical Research, Medtronic, Minneapolis, MN, United States – sequence: 7 givenname: Mary Jo surname: Johnson fullname: Johnson, Mary Jo organization: Department of Clinical Research, Medtronic, Minneapolis, MN, United States – sequence: 8 givenname: Carine surname: Van den Abeele fullname: Van den Abeele, Carine organization: Department of Clinical Research, Medtronic International Trading Sàrl, Tolochenaz, Switzerland – sequence: 9 givenname: Richard surname: North fullname: North, Richard organization: Department of Neurosurgery, Johns Hopkins University (retired), Baltimore, MD, United States
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Snippet	Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective...
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SubjectTerms	Adult Back Pain - complications Back Pain - therapy Failed Back Surgery Syndrome - therapy Female Humans Low Back Pain - complications Low Back Pain - therapy Male Middle Aged Neuralgia - etiology Neuralgia - therapy Neurosurgical Procedures - adverse effects Pain Management Pain Measurement - methods Prospective Studies Quality of Life Spinal Cord Stimulation - methods
Title	Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial
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