Rescue therapy with novel waveform spinal cord stimulation for patients with failed back surgery syndrome refractory to conventional stimulation: a systematic review and meta-analysis

Sally El SammakDepartment of Neurologic Surgery, Mayo Clinic, Rochester;

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William MualemDepartment of Neurologic Surgery, Mayo Clinic, Rochester;

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Giorgos D. MichalopoulosDepartment of Neurologic Surgery, Mayo Clinic, Rochester;

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Joshua M. RomeroDepartment of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota; and

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Christopher T. HaDepartment of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota; and

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Christine L. HuntAnesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Jacksonville, Florida

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Mohamad BydonDepartment of Neurologic Surgery, Mayo Clinic, Rochester;

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OBJECTIVE

Conventional spinal cord stimulators (SCSs) have demonstrated efficacy in individuals with failed back surgery syndrome (FBSS). However, a subgroup of patients may become refractory to the effects of conventional waveforms over time. The objective of this study was to systematically review and evaluate the current literature on the use of novel waveform spinal cord stimulation for the management of FBSS refractory to conventional SCSs.

METHODS

A comprehensive electronic search of the literature published in electronic databases, including Ovid MEDLINE and Epub Ahead of Print, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus, was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The outcomes of interest were reduction in back pain and/or leg pain after conversion from conventional to novel SCSs. Risk of bias was assessed with the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria.

RESULTS

A total of 6 studies with 137 patients with FBSS were identified. Studies were published between 2013 and 2021. The mean ± SD age of the pooled patient sample was 55 ± 10.5 years. All patients who underwent treatment with conventional SCSs were identified. Two studies evaluated the efficacy of high-density spinal cord stimulation, 3 studies evaluated burst spinal cord stimulation, and 1 study assessed multimodal waveforms. The mean difference in back pain scores after conversion from a standard SCS to a novel waveform SCS was 2.55 (95% CI 1.59–4.08), demonstrating a significant reduction in back pain after conversion to novel stimulation. The authors also performed a subgroup analysis to compare burst stimulation to tonic waveforms. In this analysis, the authors found no significant difference in the average reductions in back pain between the 2 groups (p = 0.534).The authors found an I2 statistic equivalent to 98.47% in the meta-regression model used to assess the effect of follow-up duration on study outcome; this value implied that the variability in the data can be attributed to the remaining between-study heterogeneity. The overall certainty was moderate, with a high risk of bias across studies.

CONCLUSIONS

Rescue therapy with novel waveform spinal cord stimulation is a potential option for pain reduction in patients who become refractory to conventional SCSs. Conversion to novel waveform SCSs may potentially mitigate expenses and complications.

ABBREVIATIONS

FBSS = failed back surgery syndrome; GRADE = Grading of Recommendations, Assessment, Development and Evaluations; HD = high-density; HF = high-frequency; NRS = numeric rating scale; PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analyses; RCT = randomized controlled trial; ROBINS-I = Risk of Bias in Nonrandomized Studies of Interventions; SCS = spinal cord stimulator; VAS = visual analog scale.
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Images from Gami et al. (pp 713–721).

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