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Published in: Health and Quality of Life Outcomes 1/2018

Open Access 01-12-2018 | Research

Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting

Authors: Luciana Scalone, Furio Zucco, Angelo Lavano, Amedeo Costantini, Marisa De Rose, Paolo Poli, Gianpaolo Fortini, Laura Demartini, Enrico De Simone, Valentino Menardo, Mario Meglio, Paolo Cozzolino, Paolo A. Cortesi, Lorenzo G. Mantovani

Published in: Health and Quality of Life Outcomes | Issue 1/2018

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Abstract

Background

Failed back surgery syndrome (FBSS) represents one main cause of chronic neuropathic or mixed pain, functional disability and reduced Health Related Quality of Life (HRQoL). Spinal Cord Stimulation (SCS) can be a value for money option to treat patients refractory to conventional medical management (CMM).
We estimated from real-world data: 1) the amount of reduced levels of HRQoL of target patients compared to general population, 2) the relationship between pain intensity, functional disability, and overall HRQoL, and 3) the improvement of patients’ health from SCS intervention, and 4) we give some insights and make some suggestions on the selection of a battery of patients’ reported health instruments for use in routine clinical practice.

Methods

At recruitment (before SCS) and every 6 months for 2 years after SCS a battery of questionnaires/tests were completed: the generic EQ-5D and SF-36 for HRQoL, the specific Numerical Rating Scale (NRS) to measure pain intensity, and Oswestry Disability Index (ODI) to measure functional disability. We conducted multilevel regression analyses to investigate the association of HRQoL with the NRS and ODI indexes; multiple regression analyses to compare EQ-5D data with those of the general population adjusted for age, sex and education, and statistical tests to compare the changes of HRQoL, NRS and ODI estimates at baseline with those measured during the follow-up.

Results

Eighty patients (40% male, mean age = 58 years) participated. HRQoL was significantly worse in the patients than in the corresponding general population. Pain, functional disability and HRQoL significantly related each other during follow-up, Significant improvements (p < 0.001) in pain intensity, functional capability and HRQoL were reached after 6 months from SCS and generally remained stable during follow-up. Specific instruments provided detailed information on disability and pain, while generic instruments assessed the overall HRQoL and allowed a comparison with the general population’s one.

Conclusions

SCS + CMM treatment reaches a statistically significant and probably a clinically relevant improvement in pain perception, functional disability and HRQoL in patients with FBSS refractory to CMM. An appropriate selection of instruments for use in clinical practice is crucial for a routine assessment of health perception in patients, aimed to guide decisions for optimal treatment.
Appendix
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Metadata
Title
Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting
Authors
Luciana Scalone
Furio Zucco
Angelo Lavano
Amedeo Costantini
Marisa De Rose
Paolo Poli
Gianpaolo Fortini
Laura Demartini
Enrico De Simone
Valentino Menardo
Mario Meglio
Paolo Cozzolino
Paolo A. Cortesi
Lorenzo G. Mantovani
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2018
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-018-0887-x

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