A Visual and Narrative Timeline Review of Spinal Cord Stimulation Technology and US Food and Drug Administration Milestones.

OBJECTIVES: The aim of this study was to present key technologic and regulatory milestones in spinal cord stimulation (SCS) for managing chronic pain on a narrative timeline with visual representation, relying on original sources to the extent possible. MATERIALS AND METHODS: We identified technical advances in SCS that facilitated and enhanced treatment on the basis of scientific publications and approvals from the United States (US) Food and Drug Administration (FDA). We presented milestones limited to first use in key indications and in the context of new technology validation. We focused primarily on pain management, but other indications (eg, motor disorder in multiple sclerosis) were included when they affected technology development. RESULTS: We developed a comprehensive visual and narrative timeline of SCS technology and US FDA milestones. Since its conception in the 1960s, the science and technology of SCS neuromodulation have continuously evolved. Advances span lead design (from paddle-type to percutaneous, and increased electrode contacts) and stimulator technology (from wireless power to internally powered and rechargeable, with miniaturized components, and programmable multichannel devices), with expanding stimulation program flexibility (such as burst and kilohertz stimulation frequencies), as well as usage features (such as remote programming and magnetic resonance imaging conditional compatibility). CONCLUSIONS: This timeline represents the evolution of SCS technology alongside expanding FDA-approved indications for use.

Spinal cord stimulation as treatment for complex regional pain syndrome should be considered earlier than last resort therapy.

BACKGROUND: Spinal cord stimulation (SCS), by virtue of its historically described up-front costs and level of invasiveness, has been relegated by several complex regional pain syndrome (CRPS) treatment algorithms to a therapy of last resort. Newer information regarding safety, cost, and efficacy leads us to believe that SCS for the treatment of CRPS should be implemented earlier in a treatment algorithm using a more comprehensive approach. METHODS: We reviewed the literature on pain care algorithmic thinking and applied the safety, appropriateness, fiscal or cost neutrality, and efficacy (S.A.F.E.) principles to establish an appropriate position for SCS in an algorithm of pain care. RESULTS AND CONCLUSION: Based on literature-contingent considerations of safety, efficacy, cost efficacy, and cost neutrality, we conclude that SCS should not be considered a therapy of last resort for CRPS but rather should be applied earlier (e.g., three months) as soon as more conservative therapies have failed.

[Development of epidural spinal cord stimulation. Fortieth anniversary of the first implantation in Germany]. / Entwicklung der epiduralen Rückenmarkstimulation. 40 Jahre seit der Erstimplantation in Deutschland.

Spinal cord stimulation is nowadays an established therapy for various neuropathic and vasculopathic pain syndromes after more conservative measures have failed. However, 40 years ago, only 5 years after the first worldwide implantation in the US, this therapy was promoted in Germany. In 1972, the first devices were implanted in the Departments of Neurosurgery at the Universities Hannover and Freiburg. These pioneering efforts and the establishment of the therapy are intimately associated with three names: Jörg-Ulrich Krainick, Uwe Thoden, and Wolfhard Winkelmüller. Nowadays about 1700 spinal cord stimulation systems are implanted annually in Germany. The development of spinal cord stimulation from the beginnings up to now taking into special consideration the early years in Germany are presented.

Spinal cord stimulation for the treatment of neuropathic pain: expert opinion and 5-year outlook.

INTRODUCTION: Spinal cord stimulation (SCS) is an effective treatment for chronic, intractable neuropathic pain. There have been relatively few high-level studies that suggest its unequivocal use. The decay of stimulation efficacy over time have opened opportunity for the entrance of new pulse trains and waveforms. AREAS COVERED: In this state-of-the-art review, we focused on many of the major studies published in the last 10 years that were considered level one evidence. A retrospective narrative approach was taken to conceptualize foundation studies as they pertain to current evidence. A special focus was taken on reported safety outcomes in comparison to foundation studies especially as they pertain to our 5-year outlook on the use of spinal cord stimulation. EXPERT OPINION: We find there are still significant limitations in the body of reviewed evidence and suggest that long-term data beyond 24 months are lacking in the literature. In addition, adverse event rates, device explantation rates and the sham effect looms as important concepts to address in the future in spite of the existing novel stimulation paradigms.