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Real-world device survival, revision burden and observed pain patterns after epidural spinal cord stimulation for neuropathic pain in adults with spinal cord injury: protocol for a longitudinal observational cohort study using routine clinical data

Year: 2026

Type: article

Abstract: Introduction Neuropathic pain affects 40–70% of people with chronic spinal cord injury (SCI), but real-world device survival, revision burden and pain trajectories after epidural spinal cord stimulation (eSCS) remain poorly characterised, with no Canadian programme-level evidence base. This protocol describes a 10-year longitudinal observational cohort study quantifying long-term device survival, revision burden and observed documentation-based pain patterns after eSCS for SCI-associated neuropathic pain at a single quaternary centre, under pre-specified protocol governance. Methods and analysis Design: longitudinal observational cohort with retrospective and rolling accrual from finalised routine clinical documentation. Setting: The Ottawa Hospital, Ottawa, Canada (single quaternary academic centre). Participants: adults (≥18 years) with confirmed SCI undergoing eSCS implantation for neuropathic pain, 1 January 2024 to 31 December 2034. Data source: finalised Epic electronic medical records; no research procedures imposed. Primary outcome: device survival (Kaplan-Meier). Key secondary outcome: longitudinal Numeric Rating Scale/Visual Analogue Scale-equivalent pain patterns, summarised descriptively and, if data density permits, using a mixed-effects model. Secondary endpoints: revision burden, device-related adverse events, responder durability, analgesic burden change and healthcare utilisation. Analytic trigger: ≥10 participants with ≥12 months follow-up; definitive analysis at year 10. Projected cohort: 20–40 participants over 10 years. Ethics and dissemination This study has been approved by The Ottawa Health Science Network Research Ethics Board under delegated minimal-risk procedures (Protocol ID: 20260238-01H; approved 17 April 2026), with institutional approval from The Ottawa Hospital Research Institute on the same date. A waiver of individual consent has been granted under the Tri-Council Policy Statement (Articles 5.5 and 3.7A); the study complies with Ontario’s Personal Health Information Protection Act, Section 44. This protocol references applicable Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 items as a structural reporting guide, though it is an observational secondary-use study rather than an interventional trial. Findings will be disseminated through peer-reviewed publications and conferences in neurosurgery, neuromodulation and spinal cord medicine.

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-125558

Authors: Sasi Kumar Jagadeesan, Emam Khan, Ryan Sandarage, Alan Chalil, Eve C Tsai

Institutions: University of Ottawa, Ottawa Hospital, Ottawa Hospital Research Institute

Language: English

Topic: Pain Management and Treatment

Subfield: Anesthesiology and Pain Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,839