Gianpaolo Fortini

Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome

Abstract Patients with neuropathic pain secondary to failed back surgery syndrome (FBSS) typically experience persistent pain, disability, and reduced quality of life. We hypothesised that spinal cord stimulation (SCS) is an effective therapy in addition to conventional medical management (CMM) in this patient population. We randomised 100 FBSS patients with predominant leg pain of neuropathic radicular origin to receive spinal cord stimulation plus conventional medical management (SCS group) or conventional medical management alone (CMM group) for at least 6 months. The primary outcome was the proportion of patients achieving 50% or more pain relief in the legs. Secondary outcomes were improvement in back and leg pain, health‐related quality of life, functional capacity, use of pain medication and non‐drug pain treatment, level of patient satisfaction, and incidence of complications and adverse effects. Crossover after the 6‐months visit was permitted, and all patients were followed up to 1 year. In the intention‐to‐treat analysis at 6 months, 24 SCS patients (48%) and 4 CMM patients (9%) (p < 0.001) achieved the primary outcome. Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction (p ⩽ 0.05 for all comparisons). Between 6 and 12 months, 5 SCS patients crossed to CMM, and 32 CMM patients crossed to SCS. At 12 months, 27 SCS patients (32%) had experienced device‐related complications. In selected patients with FBSS, SCS provides better pain relief and improves health‐related quality of life and functional capacity compared with CMM alone.

The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation

OBJECTIVEAfter randomizing 100 failed back surgery syndrome patients to receive spinal cord stimulation (SCS) plus conventional medical management (CMM) or CMM alone, the results of the 6-month Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation (i.e., PROCESS) showed that SCS offered superior pain relief, health-related quality of life, and functional capacity. Because the rate of crossover favoring SCS beyond 6 months would bias a long-term randomized group comparison, we present all outcomes in patients who continued SCS from randomization to 24 months and, for illustrative purposes, the primary outcome (>50% leg pain relief) per randomization and final treatment. METHODSPatients provided data on pain, quality of life, function, pain medication use, treatment satisfaction, and employment status. Investigators documented adverse events. Data analysis included inferential comparisons and multivariate regression analyses. RESULTSThe 42 patients continuing SCS (of 52 randomized to SCS) reported significantly improved leg pain relief (P < 0.0001), quality of life (P ≤ 0.01), and functional capacity (P = 0.0002); and 13 patients (31%) required a device-related surgical revision. At 24 months, of 46 of 52 patients randomized to SCS and 41 of 48 randomized to CMM who were available, the primary outcome was achieved by 17 (37%) randomized to SCS versus 1 (2%) to CMM (P = 0.003) and by 34 (47%) of 72 patients who received SCS as final treatment versus 1 (7%) of 15 for CMM (P = 0.02). CONCLUSIONAt 24 months of SCS treatment, selected failed back surgery syndrome patients reported sustained pain relief, clinically important improvements in functional capacity and health-related quality of life, and satisfaction with treatment.

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.

Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study).

Introduction.  Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re‐operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost‐effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS.

Treatment of failed back surgery syndrome.

Objectives. To evaluate the long‐term results of different therapies for failed back surgery syndrome (FBSS).

Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study

To assess the cost‐effectiveness and cost‐utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM).

The Infection Risk of Intrathecal Drug Infusion Pumps after Multiple Refill Procedures

The objective of this study was to evaluate the long‐term infection risk from refilling intrathecal drug delivery devices. We studied 25 patients (14 females and 11 males) with intrathecal infusion pumps placed for spasticity (23 patients) and chronic pain (two patients). In this study group there were 890 refill procedures (mean 35.6 ± 20.5; range 8–72 times) performed on an outpatient basis by four different physicians. All refill procedures were performed in a sterile and standardized fashion as suggested by the manufacturer, using manufacturers approved kits for the refills. During the study period, five patients had recurrent infection of the urinary tract and three patients had recurrent infections of the respiratory tract. At the last pump refill of each patient, residual drug, extracted from the pump reservoir, was sent to a laboratory for aerobic and anaerobic cultures. All cultures, in all pumps, were negative for aerobic and anaerobic bacteria. We conclude that periodic refills of intrathecal implanted pumps do not seem to be a risk factor for infection if standard sterile refill procedures are performed. In this study, it was clear that comorbid infections from other parts of the body do not present as a risk for device contamination.

Letter to the editor: Clinical Use, Quality of Life and Cost-Effectiveness of Spinal Cord Stimulation Used to Treat Patients with Failed Back Surgery Syndrome

Copyright C 2017 by Korean Society of Spine Surgery This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Asian Spine Journal • pISSN 1976-1902 eISSN 1976-7846 • www.asianspinejournal.org Received May 10, 2017; Accepted 20-May 20, 2017 Corresponding author: Luciana Scalone CESP, Research Centre on Public Health, University of Milan Bicocca Via Cadore, 48, Monza I-20900, Italy Tel: +39-(0)39-2333097, Fax: +39-(0)2-700536422, E-mail: luciana.scalone@unimib.it

Il costo della sindrome da fallimento chirurgico spinale (Failed Back Surgery Syndrome, FBSS) nei pazienti con indicazione a impianto per neurostimolazione midollare in Italia

ObjectiveTo assess the costs and clinical condition of Failed Back Surgery Syndrome (FBSS) for patients eligible for Spinal Cord Stimulation (SCS) in Italy.MethodsA multicentre, retrospective data collection with a maximum time horizon of 12 months was developed. Nine Italian Centers experienced in SCS were involved enrolling 80 patients. Use and costs of healthcare and non-healthcare resources, clinical condition and HR-QoL data were collected through specific questionnaires submitted to patients. Mean monthly costs (EUR 2008) were evaluated according to three perspectives: Patient, National Healthcare System (NHS) and Society.ResultsA strong impairment in baseline HR-QoL was documented. Mean utility score was 0.07 (general UK population: 0.70). According to the Oswestry questionnaire, 44% of patients were crippled and 39% severely disabled. All SF-36 dimensions were worse than in normal population. To treat FBSS, monthly expenditure per patient was equal to €177.34, €221.12 and €1,046.12 from the perspectives of Patient, NHS and Society, respectively. Productivity losses accounted for 62% of the societal total costs, while hospitalizations explained 28% of the costs sustained by the NHS. From the patient perspective, the main cost drivers were home care (27%) and travel expenses (26%).ConclusionsThis Cost-of-Illness analysis confirms FBSS as a disabling and costly disease.

Relationship between Pain, Functional Disability and Health-Related Quality of Life in Patient with Failed Back Surgery Syndrome Undergoing Spinal Cord Stimulation: Results from the Precise Study

Objectives: Osteoarthritis (OA) is the most common and costly bone and joint disease in the elderly. Recently, viscosupplementation, an intra-articular injection of artificial joint fluid in order to restore rheological properties affecting lubrication and shock absorption, has introduced as an alternative conservative treatment. To assess the effectiveness and cost-effectiveness of Hylan G-F 20 (Hylan) as a substitute for existing treatments for pain due to OA of the knee, other viscosupplementation devices, and/or as an adjunct to conventional therapy. MethOds: A Markov microsimulation model was developed to define a treatment pathway for OA of the knee, illustrate the current costs of treating patients with the condition, and demonstrate the potential savings associated with introduction of Hylan. A hypothetical cohort of patients categorized as having 2-3 or 4 degree of OA of the knee was followed over a 30-month time period. Results: When comparing intra-articular administration of Hylan, the use of NSAIDs and intra-articular administration of corticosteroids (GCS), rirost costs compared with the strategy of NSAIDs amounted to