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. 2024 Jul 17:19:100528.
doi: 10.1016/j.xnsj.2024.100528. eCollection 2024 Sep.

Twelve-month results from a randomized controlled trial comparing differential target multiplexed spinal cord stimulation and conventional spinal cord stimulation in subjects with chronic refractory axial low back pain not eligible for spine surgery

Thomas White  1 , Rafael Justiz  2 , Wilson Almonte  3 , Velimir Micovic  4 , Binit Shah  5 , Eric Anderson  6 , Leonardo Kapural  7 , Harold Cordner  8 , Amr El-Naggar  9 , Michael Fishman  10 , Yashar Eshraghi  11 , Philip Kim  10 , Al Abd-Elsayed  12 , Krishnan Chakravarthy  13   14 , Yoann Millet  1 , Mahendra Sanapati  15 , Nathan Harrison  11 , Brandon Goff  16 , Mayank Gupta  17 , Prabhdeep Grewal  16 , Michael Wilkinson  18 , Richard Bundschu  19 , Andrew Will  20 , Pankaj Satija  21 , Sean Li  22 , Scott Dulebohn  18 , John Broadnax  6 , Gennady Gekht  19 , Ken Wu  1 , Steven Falowski  10 , Wesley Park  23 , David L Cedeno  23 , Ricardo Vallejo  23
Affiliations

Twelve-month results from a randomized controlled trial comparing differential target multiplexed spinal cord stimulation and conventional spinal cord stimulation in subjects with chronic refractory axial low back pain not eligible for spine surgery

Thomas White et al. N Am Spine Soc J. .

Abstract

Background: Successful treatments for intractable chronic low back pain (CLBP) in patients who are not eligible for surgical interventions are scarce. The superior efficacy of differential target multiplexed spinal cord stimulation (DTM SCS) to conventional SCS (Conv-SCS) on the treatment of CLBP in patients with persistent spinal pain syndrome (PSPS) who have failed surgical interventions (PSPS-T2) motivated the evaluation of DTM SCS versus Conv-SCS on PSPS patients who are non-surgical candidates (PSPS-T1).

Methods: This is a prospective, open label, crossover, post-market randomized controlled trial in 20 centers across the United States. Eligible patients were randomized to either DTM SCS or Conv-SCS in a 1:1 ratio. Primary endpoint was CLBP responder rate (percentage of subjects with ≥50% CLBP relief) at 3-month in randomized subjects who completed trialing (modified intention-to-treat population). Patients were followed up to 12 months. Secondary endpoints included change of CLBP and leg pain, responder rates, changes in disability, quality of life, patient satisfaction and global impression of change, and safety profile. An optional crossover was available at 6-month to all patients.

Results: About 121 PSPS-T1 subjects with CLBP and leg pain mostly associated with degenerative disc disease and radiculopathy and who were not eligible for spine surgery were randomized. CLBP responder rate with DTM SCS (93.5%) was superior to Conv-SCS (36.4%) at the primary endpoint. Superior CLBP responder rates (88.1%-90.5%) were obtained with DTM SCS at all other timepoints. Mean CLBP reduction with DTM SCS (6.52 cm) was superior to that with Conv-SCS (3.01 cm) at the primary endpoint. Similar CLBP reductions (6.23-6.43 cm) were obtained with DTM SCS at other timepoints. DTM SCS provided significantly better leg pain reduction and responder rate, improvement of disability and quality of life, and better patient satisfaction and global impression of change. 90.9% of Conv-SCS subjects who crossed over were CLBP responders at completion of the study. Similar safety profiles were observed between the two groups.

Conclusion: DTM SCS for chronic CLBP in nonsurgical candidates is superior to Conv-SCS. Improvements were sustained and provided significant benefits on the management of these patients.

Keywords: Conventional SCS; Differential target multiplexed SCS; Nonsurgical candidates; Persistent spinal pain syndrome type 1; Randomized controlled trial; Spinal cord stimulation.

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Conflict of interest statement

One or more of the authors declare financial or professional relationships on ICMJE-NASSJ disclosure forms.

Figures

Fig 1
Fig. 1
Subject disposition of study subjects.
Fig 2
Fig. 2
Back pain responder rate at various time points of the study. Error bars are 95% CI. DTM SCS was superior at all time points. Results are obtained for the mITT using a repeated measures model for imputation of missing data. Crossover data was censored in this analysis.
Fig 3
Fig. 3
Back pain VAS scores along the 12-month follow up visits for DTM SCS and Conv-SCS in the mITT population and with crossover data censored. Error bars correspond to standard errors.
Fig 4
Fig. 4
Back pain reduction relative to baseline at the various time points of the study. Error bars are 95% CI. DTM SCS was superior at all time points. Results were obtained for the mITT population using a repeated measures model for imputation of missing data. Crossover data was censored in this analysis.
Fig 5
Fig. 5
Leg pain VAS scores along the 12-month follow up visits for DTM SCS and Conv-SCS in the mITT subjects with baseline leg VAS ≥ 5 cm, including the record for subjects that crossed over from the control to the test arm. Error bars correspond to standard errors.
Fig 6
Fig. 6
Leg responder rate (left graph) and leg pain reduction from baseline (right graph) at various time points of the study. Error bars are 95% CI. DTM SCS was superior at all time points. Results obtained for the mITT using a repeated measures model for imputation of missing data, including the record from subjects that crossed over from Conv-SCS to DTM SCS at the 6-month visit.
Fig 7
Fig. 7
Improvement in functional disability (ODI) along the 12-month visits for DTM SCS and Conv-SCS. Error bars correspond to standard errors. Differences of mean improvement between treatments are significant.
Fig 8
Fig. 8
Change in EQ-5D-5L index (left graph) and EQ-5D-5L VAS score (right graph) relative to baseline along the 12-month visits for DTM SCS and Conv-SCS. Error bars correspond to standard errors. Differences between mean improvement between treatment are significant for all comparisons except for EQ-5D-5L VAS score at 9 months.
See this image and copyright information in PMC

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