Reporting guidelines for protocols of randomised controlled trials of implantable neurostimulation devices: the SPIRIT-iNeurostim extension.

Background: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in protocols of clinical trials of implantable neurostimulation devices are common.

Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension.

Background: The Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reporting of randomised trials. Extensions to the CONSORT statement are often needed to address specific issues of trial reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in clinical trials of implantable neurostimulation devices are common.

Disease applications of spinal cord stimulation: Chronic nonmalignant pain.

Neuropathic pain is a chronic condition representing a significant burden for society. It is estimated 1 out of 10 people over the age of 30 that in the US have been diagnosed with neuropathic pain. Most of the available treatments for neuropathic pain have moderate efficacy over time which limit their use; therefore, other therapeutic approaches are needed for patients.

A Definition of Neuromodulation and Classification of Implantable Electrical Modulation for Chronic Pain.

Objectives: Neuromodulation therapies use a variety of treatment modalities (eg, electrical stimulation) to treat chronic pain. These therapies have experienced rapid growth that has coincided with escalating confusion regarding the nomenclature surrounding these neuromodulation technologies. Furthermore, studies are often published without a complete description of the effective stimulation dose, making it impossible to replicate the findings.

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources.

Objective: Spinal cord stimulation (SCS) thresholds are known to change with body position; however, these changes have not been fully characterized for both "constant-voltage" and "constant-current" pulse generators. This study aimed to evaluate and quantify changes in psychophysical thresholds resulting from postural changes that may affect both conventional paresthesia-based SCS and novel paresthesia-free SCS technologies.

Materials And Methods: We measured perceptual, usage, and discomfort thresholds in four body positions (prone, supine, sitting, standing) in 149 consecutive patients, with temporary lower thoracic percutaneous epidural electrodes placed for treating persistent low back and leg pain.

Screening trials of spinal cord stimulation for neuropathic pain in England-A budget impact analysis.

Screening trials of spinal cord stimulation (SCS) prior to full implantation of a device are recommended by expert guidelines and international regulators. The current study sought to estimate the budget impact of a screening trial of SCS and the costs or savings of discontinuing the use of a screening trial. A budget impact analysis was performed considering a study population that reflects the size and characteristics of a patient population with neuropathic pain in England eligible for SCS.

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.

Trends in Utilization and Cost of Inpatient Spinal Cord Stimulation: Analysis of Data from 2008 to 2014.

Objective: In this study, we sought to characterize contemporary trends in cost and utilization of spinal cord stimulation (SCS).

Methods: The Healthcare Cost and Utilization Project-National Inpatient Sample was queried for inpatient admissions from 2008 to 2014 where SCS was performed. We then determined the rates and costs of SCS performed in this time frame to treat diagnoses that we classified as device-related complications, degenerative spine disease, pain syndromes, and neuropathies/neuritis/nerve lesions.

Examining the Need to Standardize Implanted Stimulator Connectors: NANS Survey Results.

Introduction: Connectors between implanted stimulator electrodes and pulse generators allow revisions, including battery changes or generator upgrades, to proceed without disturbing uninvolved components, such as the electrode. As new devices are introduced, however, connector incompatibility, even with updated hardware from the same manufacturer, can lead to additional procedures, expense, and morbidity.

Materials And Methods: Following the example of the cardiac pacemaker/defibrillator industry, the Institute of Neuromodulation (IoN) met to explore the possibility of creating connector standards for implanted neurostimulation devices.

Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation for Pain.

This systematic review assessed design characteristics and reporting quality of published randomized clinical trials of spinal cord stimulation (SCS) for treatment of pain in adults and adolescents. The study protocol was registered with PROSPERO (CRD42018090412). Relevant articles were identified by searching the following databases through December 31, 2018: MEDLINE, Embase, WikiStim, The Cochrane Database of Systematic Reviews, and The Cochrane Central Register of Controlled Trials.

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.

Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain.

The aims of this review were to systematically identify the current evidence base of placebo (or "sham") randomised controlled trials (RCTs) of spinal cord stimulation (SCS) for neuropathic pain and to undertake a meta-analysis to investigate the effectiveness of SCS when compared with a placebo comparator arm. Electronic databases were searched from inception until January 2019 for RCTs of SCS using a placebo/sham control. Searches identified 8 eligible placebo-controlled randomised trials of SCS for neuropathic pain.

Randomized Placebo-/Sham-Controlled Trials of Spinal Cord Stimulation: A Systematic Review and Methodological Appraisal.

Objectives: The recent availability of paraesthesia/sensation free spinal cord stimulation (SCS) modalities allow the design of clinical trials of SCS using placebo/sham controls and blinding of patients, clinicians, and researchers. The aims of this study were to: 1) systematically review the current evidence base of randomized controlled trials (RCTs) of SCS placebo/sham trials and 2) to undertake a methodological critique of their methods. Based on this critique, we developed a checklist for the design and reporting of future RCTs of SCS.

Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.

Background: "Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely.

Objective: To evaluate fully implanted wireless SCS devices during a 30-day screening trial in subjects with chronic low back pain and leg pain and a history of lumbosacral spine surgery.

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.