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Real-world outcomes in spinal cord stimulation: predictors of reported effect and explantation using a comprehensive registry-based approach
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Pain. Akadem Sjukhuset, S-75185 Uppsala, Sweden..ORCID iD: 0000-0001-9011-4711
Quantify Res, Stockholm, Sweden.;Karolinska Inst, Dept Learning Informat Management & Eth, Stockholm, Sweden..
Quantify Res, Stockholm, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Pain. Akadem Sjukhuset, S-75185 Uppsala, Sweden..ORCID iD: 0000-0003-3923-4093
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2023 (English)In: Pain Reports, E-ISSN 2471-2531, Vol. 8, no 6, article id e1107Article in journal (Refereed) Published
Abstract [en]

Introduction: Despite advancements in implanted hardware and development of novel stimulation paradigms in Spinal Cord Stimulation (SCS), real world evidence suggests a large variation in patient reported outcomes and a proportion of patients are later explanted due to loss of analgesia. Possible predictors for outcome have been explored in smaller short-term evaluations, but few clinically applicable robust measures for long term outcome have emerged.

Methods: We performed a comprehensive retrospective study based on an assembled patient-level aggregated database from multiple local and national registries in Sweden. Variables associated with risk of explantation (due to insufficient analgesia) and analgesic effect was analyzed using a Cox regression analysis and an ordered logit regression model, respectively.

Results: We found the accumulated risk of explantation due to loss of analgesia to be 10% and 21% at two and ten years follow up, respectively. The use of 10 kHz spinal cord stimulation (compared with Tonic waveform; p = 0.003), and being 60 years or older (reference 18-40 years; p = 0.003) were associated with an increased risk of explantation.At a mean follow up at 1 year, 48% of patients reported a pain intensity reduction from baseline of at least 30%. Secondary (p = 0.030) and post-secondary (p = 0.001) education (compared with primary education) was associated with an increased probability of successful patient reported outcomes.Results:We found the accumulated risk of explantation due to loss of analgesia to be 10% and 21% at two and ten years follow up, respectively. The use of 10 kHz spinal cord stimulation (compared with Tonic waveform; p = 0.003), and being 60 years or older (reference 18-40 years; p = 0.003) were associated with an increased risk of explantation.At a mean follow up at 1 year, 48% of patients reported a pain intensity reduction from baseline of at least 30%. Secondary (p = 0.030) and post-secondary (p = 0.001) education (compared with primary education) was associated with an increased probability of successful patient reported outcomes.

Conclusion: This study suggests that a higher educational level and being employed are associated with successful treatment outcome in patients with chronic pain treated with SCS in Sweden.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2023. Vol. 8, no 6, article id e1107
Keywords [en]
Neuromodulation, Administrative register, Chronic pain, Effectiveness, Education, Real-world evidence
National Category
Neurology
Identifiers
URN: urn:nbn:se:uu:diva-516899DOI: 10.1097/PR9.0000000000001107ISI: 001104153900001PubMedID: 38027468OAI: oai:DiVA.org:uu-516899DiVA, id: diva2:1816442
Available from: 2023-12-01 Created: 2023-12-01 Last updated: 2024-02-26Bibliographically approved

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Kirketeig, TerjeKarlsten, Rolf

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