Line Jacques

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.

Functional outcome of brachial plexus reconstruction after trauma.

OBJECTIVETraumatic brachial plexopathies can be devastating injuries. In addition to motor and sensory deficits, pain and functional limitations can be equally debilitating. We sought to evaluate functional outcome and quality of life using statistically validated tools. METHODSThe authors identified a consecutive series of patients who underwent surgical repair of a brachial plexus injury by the same surgeon between 1997 and 2004 at the McGill University Health Center. Participating patients were sent a package containing the Short Form 36, the Disability of the Arm, Shoulder, and Hand questionnaire, a pain visual analog scale, and an additional question on their satisfaction with the surgery. Data was recorded and analyzed using statistical software (SPSS version 13.0 for Windows; SPSS, Inc., Chicago, IL). RESULTSThirty-one patients with a mean age of 32.7 years at the time of injury participated in this study. The mean time to surgery was 7.5 months, and the mean follow-up period was 42.7 months. Patients who underwent surgery within 6 months of injury scored consistently better on the Disability of the Arm, Shoulder, and Hand questionnaire (P = 0.03) and the Short Form 36 subscale scores. There was no difference between supra- and infraclavicular injuries; however, patients with root avulsion injuries were more likely to have pain (P = 0.04) and scored lower on the Disability of the Arm, Shoulder, and Hand questionnaire (P = 0.05). CONCLUSIONStatistically validated tools can be used to evaluate the quality of life, upper extremity function, and pain after brachial plexus repairs. Root avulsion injuries and delayed surgical repair correlated negatively with functional outcomes.

Demographic Characteristics of Patients with Severe Neuropathic Pain Secondary to Failed Back Surgery Syndrome

Background:  Neuropathic pain commonly affects the back and legs and is associated with severe disability and psychological illness. It is unclear how patients with predominantly neuropathic pain due to failed back surgery syndrome (FBSS) compare with patients with other chronic pain conditions.

Recurrent Spontaneous Spinal Cerebrospinal Fluid Leak Associated with "Nude Nerve Root" Syndrome: Case Report

OBJECTIVE AND IMPORTANCESpontaneous spinal cerebrospinal fluid (CSF) leaks have been noted occasionally at multiple sites in the same patient, but recurrent spontaneous spinal CSF leaks have not been documented. We describe a patient with a recurrent CSF leak who was found at surgery to have an absence of the entire nerve root sleeve at multiple thoracic levels. CLINICAL PRESENTATIONA 29-year-old woman bodybuilder noted an excruciating orthostatic headache associated with nausea. The neurological examination was unremarkable, and a magnetic resonance imaging examination showed the typical changes of intracranial hypotension. Computed tomographic myelography showed an extensive bilateral lower cervical CSF leak. INTERVENTIONThe patient underwent bilateral lower cervical nerve root explorations, and several small dural holes were found. The CSF leaks were repaired, but 3 months later, computed tomographic myelography showed a new CSF leak in the midthoracic area. A thoracic laminectomy was performed, and several nerve roots were found to be completely devoid of dura. After the CSF leaks were repaired, there was significant improvement in her headaches. CONCLUSIONA recurrent spontaneous spinal CSF leak may occur in patients with intracranial hypotension at a site previously documented not to be associated with a CSF leak. Absent nerve root sleeves may be found in patients with spontaneous spinal CSF leaks (“nude nerve root” syndrome), and these patients may be at increased risk of developing a recurrent CSF leak.

Neurogenic thoracic outlet syndrome: current diagnostic criteria and advances in MRI diagnostics.

Neurogenic thoracic outlet syndrome (nTOS) is caused by compression of the brachial plexus as it traverses from the thoracic outlet to the axilla. Diagnosing nTOS can be difficult because of overlap with other complex pain and entrapment syndromes. An nTOS diagnosis is made based on patient history, physical exam, electrodiagnostic studies, and, more recently, interpretation of MR neurograms with tractography. Advances in high-resolution MRI and tractography can confirm an nTOS diagnosis and identify the location of nerve compression, allowing tailored surgical decompression. In this report, the authors review the current diagnostic criteria, present an update on advances in MRI, and provide case examples demonstrating how MR neurography (MRN) can aid in diagnosing nTOS. The authors conclude that improved high-resolution MRN and tractography are valuable tools for identifying the source of nerve compression in patients with nTOS and can augment current diagnostic modalities for this syndrome.

An Algorithmic Programming Approach for Back Pain Symptoms in Failed Back Surgery Syndrome Using Spinal Cord Stimulation with a Multicolumn Surgically Implanted Epidural Lead: A Multicenter International Prospective Study

Many studies have demonstrated the efficacy and the medical/economic value of epidural spinal cord stimulation for the treatment of “failed back surgery syndrome” (FBSS). However, the back pain component of FBSS has been recalcitrant. Recent clinical trials have suggested that multicolumn surgically implanted leads combined with enhanced programming capabilities in the newer implantable pulse generators demonstrate the ability to treat the back pain component of FBSS. The objective of our present international multicentre study is to prospectively evaluate these findings in a larger population.

Peripheral Nerve Stimulation for Chronic Neurogenic Pain

Peripheral nerve stimulation (PNS) has been used for the treatment of neuropathic pain for more than 40 years. Recent interest in the utilization of this technique stems from the many modifications of the original procedure and the refinement of the available hardware. This rendered the procedure less traumatic and more effective, and thus more widely accepted as a neuromodulation technique for the treatment of various chronic pain syndromes including post-traumatic and postsurgical neuropathy, occipital neuralgia, and complex regional pain syndromes, and in relatively new indications for neuromodulation, such as migraines and daily headaches, cluster headaches. We present a review of the principle and indications for the use of PNS, and review our single institution experience that comprises 24 peripheral nerve stimulators as well as 8 occipital nerve stimulators over 13 years. We review the protocol of our approach including the surgical nuances for our implantation technique. Collaborative efforts in future research will lead to a growth in our clinical experience with the utilization of PNS and will help in identifying the best candidates for it. This, along with the development and refinement of the available hardware would lead to a more specific patient selection for each modality of treatment, increasing the efficacy and success of the intended treatment.