Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial)

Received 22 August 2007; received in revised form 28 January 2008; accepted 28 January 2008. published online 25 March 2008.

Abstract

Background

Chronic back and leg pain conditions result in patients’ loss of function, reduced quality of life and increased costs to the society.

Aims

To assess health-related quality of life (HRQoL) and cost implications of spinal cord stimulation plus non-surgical conventional medical management (SCS group) versus non-surgical conventional medical management alone (CMM group) in the management of neuropathic pain in patients with failed back surgery syndrome.

Methods

A total of 100 patients were randomised to either the SCS or CMM group. Healthcare resource consumption data relating to screening, the use of the implantable generator in SCS patients, hospital stay, and drug and non-drug pain-related treatment were collected prospectively. Resource consumption was costed using UK and Canadian 2005–2006 national figures. HRQoL was assessed using the EuroQol-5D (EQ-5D) questionnaire. Costs and outcomes were assessed for each patient over their first 6-months of the trial.

Results

The 6-month mean total healthcare cost in the SCS group (CAN$19,486; €12,653) was significantly higher than in the CMM group (CAN$3994; €2594), with a mean adjusted difference of CAN$15, 395 (€9997) (p<0.001). However, the gain in HRQoL with SCS over the same period of time was markedly greater in the SCS group, with a mean EQ-5D score difference of 0.25 [p<0.001] and 0.21 [p<0.001], respectively at 3- and 6-months after adjusting for baseline variables.

Conclusions

The addition of SCS to CMM in patients with neuropathic leg and back pain results in higher costs to health systems but also generates important improvements in patients’ EQ-5D over the same period.

Keywords: Costs, Quality of life, Neuropathic pain, Spinal cord stimulation, Randomised controlled trial

a Centre for Health Economics, Alcuin A Block, University of York, York YO10 5DD, United Kingdom

b Department of Neurosurgery, Regina General Hospital, Regina, Canada

c Peninsula Medical School, Peninsula Technology Assessment Group, Universities of Exeter and Plymouth, United Kingdom

d Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Canada

e Department of Pain and Anaesthesia, James Cook University Hospital, Middlesbrough, United Kingdom

f Department of Functional Neurosurgery, Gemelli Catholic University Hospital, Rome, Italy

g Department of Neurosurgery, Santa Creu i Sant Pau Hospital, Barcelona, Spain

h Pain Clinic, Basildon and Thurrock University Hospitals, Basildon, United Kingdom

i Pain Clinic, Axxon Pain Medicine, Brisbane, Australia

j Pain Relief Unit, Rambam Medical Center, Haifa, Israel

k Department of Neurosurgery, Namur Regional Hospital, Namur, Belgium

l Pain Management Services and Neuromodulation Centre, EHC-Morges Hospital, Morges, Switzerland

m Pain Clinic, Varese Regional Hospital and Macchi Foundation, Varese, Italy

n Department of Pain and Anesthesia, Bradford Hospitals, Bradford, United Kingdom

o Health Economics Facility, Health Service Management Centre, University of Birmingham, United Kingdom

p Program for Assessment of Technology in Health, St. Joseph’s Hospital Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada

Corresponding author. Tel.: +44 (0) 1904321430; fax: +44 (0) 1904321402.

PII: S1090-3801(08)00021-9

doi:10.1016/j.ejpain.2008.01.014

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