Sam Eldabe

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.

The Appropriate Use of Neurostimulation of the Spinal Cord and Peripheral Nervous System for the Treatment of Chronic Pain and Ischemic Diseases: The Neuromodulation Appropriateness Consensus Committee

The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications.

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.

The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases

The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications.

The Cost-effectiveness of Spinal Cord Stimulation in the Treatment of Failed Back Surgery Syndrome

ObjectivesHealthcare policy makers and payers require cost-effectiveness evidence to inform their treatment funding decisions. Thus, in 2008, the United Kingdoms National Institute of Health and Clinical Excellence analyzed the cost effectiveness of spinal cord stimulation (SCS) compared with conventional medical management (CMM) and with reoperation and recommended approval of SCS in selected patients with failed back surgery syndrome (FBSS). We present previously unavailable details of the National Institute of Health and Clinical Excellence analysis and an analysis of the impact on SCS cost effectiveness of rechargeable implanted pulse generators (IPGs). MethodsWe used a decision analytic model to examine the cost effectiveness of SCS versus CMM and versus reoperation in patients with FBSS. We also modeled the impact of nonrechargeable versus rechargeable IPGs. ResultsThe incremental cost-effectiveness of SCS compared with CMM was £5624 per quality-adjusted life year, with 89% probability that SCS is cost effective at a willingness to pay threshold of £20,000. Compared with reoperation, the incremental cost-effectiveness of SCS was £6392 per quality-adjusted life year, with 82% probability of cost-effectiveness at the £20,000 threshold. When the longevity of an IPG is 4 years or less, a rechargeable (and initially more expensive) IPG is more cost-effective than a nonrechargeable IPG. DiscussionIn selected patients with FBSS, SCS is cost effective both as an adjunct to CMM and as an alternative to reoperation. Despite their initial increased expense, rechargeable IPGs should be considered when IPG longevity is likely to be short.

Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study.

Spinal cord stimulation is a recognized treatment of chronic neuropathic and vascular pain. Recent data suggest that the use of very high‐frequency (HF) stimulation modes does produce analgesia without paresthesia.

An analysis of the components of pain, function, and health-related quality of life in patients with failed back surgery syndrome treated with spinal cord stimulation or conventional medical management.

Objectives:  Failed back surgery syndrome (FBSS) patients experience pain, functional disability, and reduced health‐related quality of life (HRQoL) despite anatomically successful surgery. Examining sub‐dimensions of health outcomes measures provides insight into patient well‐being.

Spinal Cord Stimulation of the Dorsal Root Ganglion for Groin Pain—A Retrospective Review

Spinal cord stimulation (SCS) is a standard treatment option for chronic neuropathic pain. However, some anatomical pain distributions are known to be difficult to cover with traditional SCS‐induced paresthesias and/or may also induce additional, unwanted stimulation. We present the results from a retrospective review of data from patients with groin pain of various etiologies treated using neuromodulation of the dorsal root ganglion (DRG).