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Synergistic neuromodulation therapy for persistent spinal pain: a proof-of-concept trial on the use of spinal cord and dorsal root ganglion stimulation

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Abstract

Purpose

Persistent Spinal Pain Syndrome type 2 (PSPS-T2) poses a significant clinical challenge, demanding innovative therapeutic interventions. The integration of Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion Stimulation (DRG-S) is emerging as a potent synergistic strategy for comprehensive pain management. This single patient-blind proof of concept (POC) trial explores the efficacy and synergistic potential of combined SCS and DRG-S in a patient with refractory PSPS-T2.

Methods

A 45-year-old male with intractable PSPS-T2 underwent a unique, methodically structured study, involving three treatment phases: Phase A with SCS alone, Phase B with DRG-S alone, and Phase C The patient, blinded to the treatment modalities, provided pain assessments using the Visual Analogue Scale (VAS) and Douleur Neuropathique 4 Questions (DN4) conducted by clinical investigators at each phase. Baseline pain scores were ten and nine, respectively.

Results

Distinct responses were noted across the phases. Phase A demonstrated moderate pain relief, while Phase B offered further pain intensity reduction. However, Phase C, combining both strategies, yielded the most significant improvement, remarkably enhancing the patient’s quality of life and functional capacity.

Conclusion

This POC trial underscores the synergistic potential of SCS and DRG-S in managing complex cases of PSPS-T2, suggesting a paradigm shift towards integrated neuromodulation strategies for enhanced pain control. The development of dual intent implantable pulse generators (IPGs) capable of offering combination therapy simultaneously might be effective for pain management in select cases. The significant pain reduction and functional improvement observed advocate for further research in dual neuromodulation therapies. Trial registration number: IRB 20190536.

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Data availability

All data and materials used in this article are present and available within this manuscript.

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Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Neurological Surgery, University of Miami, 1475 NW 12th Ave, Miami, FL, 33136, USA

    Augusto Müller Fiedler, Guilherme Santos Piedade, Bernardo Assumpção de Monaco, Ruby Rose Taylor, Michelle Dawn Williams & Joacir Graciolli Cordeiro

  2. Medical Scientist Training Program, Miller School of Medicine, University of Miami, Miami, FL, USA

    Ruby Rose Taylor

  3. Miller School of Medicine, University of Miami, Miami, FL, USA

    Ruby Rose Taylor, John L. Danny & Adrienne Minor

  4. Division of Neurosurgery, Clinics Hospital, University of São Paulo, São Paulo, Brazil

    Bernardo Assumpção de Monaco

  5. Pre-Residency Fellowship Program, University of Miami/Jackson Healthcare System, Miami, FL, USA

    Michelle Dawn Williams

Authors
  1. Augusto Müller Fiedler
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  8. Joacir Graciolli Cordeiro
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Contributions

Conceptualization: Augusto Müller Fiedler, and Guilherme Santos Piedade; Methodology: Bernardo Assumpção de Monaco; Formal analysis and investigation: Augusto Müller Fiedler, Guilherme Santos Piedade; Writing—original draft preparation: Augusto Müller Fiedler, Ruby Rose Taylor; Writing—review and editing: Joacir Graciolli Cordeiro, Bernardo Assumpção de Monaco, Michelle Dawn Williams, John L. Danny, Adrienne Minor; Funding acquisition: not applicable; Resources: Augusto Müller Fiedler, Guilherme Santos Piedade, and Bernardo Assumpção de Monaco; Supervision: Joacir Graciolli Cordeiro. All authors read and approved the final manuscript.

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Correspondence to Augusto Müller Fiedler.

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The authors have no competing interests to declare that are relevant to the content of this article.

Ethical approval

Approval was obtained from the ethics committee of University of Miami Institutional Review Board (IRB 20190536). The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

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Informed consent was obtained from all individual participants included in the study.

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Fiedler, A.M., Piedade, G.S., Assumpção de Monaco, B. et al. Synergistic neuromodulation therapy for persistent spinal pain: a proof-of-concept trial on the use of spinal cord and dorsal root ganglion stimulation. Acta Neurol Belg (2024). https://doi.org/10.1007/s13760-024-02575-0

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