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


OBJECTIVE
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 euros) was significantly higher than in the CMM group (CAN$3994; 2594 euros), with a mean adjusted difference of CAN$15,395 (9997 euros) (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.
Manca
Andrea
A
Centre for Health Economics, Alcuin A Block, University of York, York YO10 5DD, United Kingdom. am126@york.ac.uk
Kumar
Krishna
K
Taylor
Rod S
RS
Jacques
Line
L
Eldabe
Sam
S
Meglio
Mario
M
Molet
Joan
J
Thomson
Simon
S
O'Callaghan
Jim
J
Eisenberg
Elon
E
Milbouw
Germain
G
Buchser
Eric
E
Fortini
Gianpaolo
G
Richardson
Jonathan
J
Taylor
Rebecca J
RJ
Goeree
Ron
R
Sculpher
Mark J
MJ
D000700:Analgesics / Q000191:economics / Q000627:therapeutic use*; D001315:Australia; D002170:Canada; D003362:Cost-Benefit Analysis; D004599:Electric Stimulation Therapy / Q000191:economics / Q000706:statistics & numerical data*; D005060:Europe; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data* / Q000639:trends; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006304:Health Status; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007557:Israel; D008136:Longevity; D017116:Low Back Pain / Q000191:economics* / Q000523:psychology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000009:adverse effects; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010523:Peripheral Nervous System Diseases / Q000191:economics* / Q000523:psychology / Q000628:therapy; D011183:Postoperative Complications / Q000191:economics* / Q000523:psychology / Q000628:therapy; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D013116:Spinal Cord / Q000502:physiology / Q000601:surgery; D013122:Spinal Diseases / Q000601:surgery; D013131:Spine / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D013577:Syndrome; D017211:Treatment Failure
D000700:Analgesics