Dataset Information

Spinal cord stimulation: a real-world data analysis on outcomes and differences between rechargeable and non-rechargeable implantable pulse generators.

ABSTRACT:

Objective

In this analysis, we examined differences between rechargeable and non-rechargeable spinal cord stimulation (SCS) devices in patients with pain.

Methods

We conducted a retrospective, longitudinal claims data analysis using a German research database comprising 5 million statutory insured patients (2012-2017). Outcomes of demographics, patient pathways, and health care resource utilization (HCRU) in patients with initial SCS were collected.

Results

Of 150 patients in the database, 73 (49%) received a rechargeable device and 77 (51%) a non-rechargeable device. The average age was 62.5 years (51% female and 49% male patients). A significant decrease over a 3-year follow-up was observed in analgesic prescriptions (-18%), number of patient visits to a physician, and number of patients who were hospitalized. HCRU-related figures for patients with non-rechargeable neurostimulators increased in the last follow-up year whereas the group receiving rechargeable neurostimulators showed a steady decrease.

Conclusions

SCS seems to be an effective way for patients with chronic pain to decrease pain and improve quality of life. Rechargeable devices seem to be superior to non-rechargeable devices owing to greater longevity and were found to be associated with continuous reduction of pain diagnoses, hospitalization, physician visits, and use of pain medication in our study.

SUBMITTER: Luecke T

PROVIDER: S-EPMC8408900 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSpinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping.MethodsThis study will enroll up to 300 subjects with chronic, intractable trunk and/or limb pain in up to 25 United States investigation sites. Subjects meeting eligibility criteria will undergo a trial procedure and a permanent implant following a successful trial. Neurophysiological measurements (measured in-clinic and continuously during home use) and clinical outcomes including pain, quality-of-life, psychological, emotional, and functional assessments will be collected at baseline, trial end, and up to 24-months post-implantation.DiscussionAssociations between objective neurophysiological data, clinical evaluation and patient-reported outcomes may have important clinical and scientific implications. They may provide novel insights about the chronic pain pathophysiology, its modulation during CL-SCS, and identification of pain phenotypes and/or mechanisms associated with treatment response during SCS trials and long-term therapy. Data from the ECAP study could lead to improvements in diagnosis, assessment, patient identification and management of chronic pain. It could also provide the foundation for development of a new SCS treatment approach customized by the patient's pain phenotype, unique neurophysiology, and disease severity.