Glossary of Neurostimulation Terminology: A Collaborative Neuromodulation Foundation, Institute of Neuromodulation, and International Neuromodulation Society Project.

Objective: Consistent terminology is necessary to facilitate communication, but limited efforts have addressed this need in the neurostimulation community. We set out to provide a useful and updated glossary for our colleagues and prospective patients.

Materials And Methods: This collaborative effort of the Neuromodulation Foundation (NF), the Institute of Neuromodulation (IoN), and the International Neuromodulation Society (INS) expands a glossary first published in 2007 for spinal cord stimulation.

Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations.

Spinal cord stimulation (SCS) is an interventional nonpharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). Although randomization overcomes certain types of bias, additional challenges to the validity of RCTs of SCS include blinding, choice of control groups, nonspecific effects of treatment variables (eg, paresthesia, device programming and recharging, psychological support, and rehabilitative techniques), and safety considerations.

Cost-Effectiveness Model Shows Superiority of Wireless Spinal Cord Stimulation Implantation Without a Separate Trial.

Objective: We evaluated the cost-effectiveness of wireless spinal cord stimulation (Wireless SCS) with single stage "direct to permanent" implantation vs. screening with temporary electrodes and an external pulse generator followed by implantation of a system for long-term use (IPG SCS).

Materials And Methods: We created a cost model that takes a 2019 United States (U.

WIKISTIM.org: An On-Line Database of Published Neurostimulation Studies.

Introduction: Primary data reported in scientific publications provide guidance for improving patient care, expanding indications, identifying research gaps, educating patients, justifying reimbursement, and gaining regulatory approval. Finding and analyzing pertinent publications among the huge volume noted in databases such as PUBMED, however, costs time and effort. This situation demands innovative ways to locate citations of (and the possibility of abstracting data from) papers reporting primary findings.

A review of economic factors related to the delivery of health care for chronic low back pain.

Introduction And Methods: We describe tools used to evaluate the economic impact of health care interventions, discuss the economic burden of chronic low back pain, and review evidence on the cost-effectiveness of treating failed back surgery syndrome with spinal cord stimulation, intrathecal drug delivery, acupuncture, epidural injections, disc prosthesis, lumbar fusion, and noninvasive therapies. We also mention the lack of cost studies for emerging therapies, such as vibrotherapy and peripheral nerve field stimulation. Topics include types of cost studies; the economic perspectives taken by such studies; direct and indirect costs; measures of success; definitions of cost-effectiveness, incremental cost-effectiveness, incremental cost-utility ratios, and quality-adjusted life years; the concept of maximum willingness to pay; and the use of cost-effectiveness models.

Prevention of percutaneous spinal cord stimulation electrode migration: a 15-year experience.

Objectives: Percutaneous spinal cord stimulation electrodes have a propensity to migrate longitudinally, which is a costly complication that often compromises therapeutic effect. After implementing simple changes to our percutaneous electrode anchoring technique, we no longer encounter this migration. The current retrospective study updates previously reported results.

Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study).

Background: Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain.

Method/design: Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States.

Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study).

Objective: This paper presents the protocol of the EVIDENCE study, a multicenter multinational randomized controlled trial to assess the effectiveness and cost-effectiveness of spinal cord stimulation (SCS) with rechargeable pulse generator versus re-operation through 36-month follow-up in patients with failed back surgery syndrome.

Study Design: Study subjects have neuropathic radicular leg pain exceeding or equaling any low back pain and meet specified entry criteria. One-to-one randomization is stratified by site and by one or more prior lumbosacral operations.

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads.

Introduction:   While reference is frequently made to the risk of spinal cord or nerve root injury with the surgical implantation of paddle type spinal cord stimulation (SCS) electrodes, data are lacking on the frequency, causes, and prevention of these complications.

Methods:   To determine the incidence and frequency of neurologic complications, we performed 1) a comprehensive analysis of the literature to determine the incidence of complications that have caused or could lead to neurologic injury; 2) an analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) data base; and 3) an investigation of manufacturers' data on surgically implanted paddle electrodes. We then convened an expert panel of neurosurgeons experienced in the surgical implantation of paddle electrodes to provide recommendations to minimize the risk of neurologic injury.

Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial.

Objective: We analyzed the cost-effectiveness and cost-utility of treating failed back-surgery syndrome using spinal cord stimulation (SCS) versus reoperation.

Materials And Methods: A disinterested third party collected charge data for the first 42 patients in a randomized controlled crossover trial. We computed the difference in cost with regard to success (cost-effectiveness) and mean quality-adjusted life years (cost-utility).