Differentiating the Leaves From the Branches in the Tree of Neuromodulation: The State of Peripheral Nerve Field Stimulation

Levy, Robert M.

doi:10.1111/j.1525-1403.2011.00359.x

Cited by 24 publications

(13 citation statements)

References 23 publications

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“…While there have been reports of treating LBP using implantable stimulation devices (ie, spinal cord stimulators) with the leads implanted subcutaneously [3][4][5], a technique that has been termed "peripheral nerve field stimulation," this is at best an experimental approach because there is no highquality outcome data to support the approach. Potentially troubling about OC's presentation is that her pain practitioner used an introduction to a patient for whom SCS was 1) used for an indication supported by outcome data, and 2) quite effective.…”

Section: Patient 1 Discussionmentioning

confidence: 98%

Ethical Challenges and Interventional Pain Medicine

Brenner

Kueppenbender

Mao

et al. 2011

Curr Pain Headache Rep

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The relief of suffering and the cure of disease must be seen as twin obligations of a medical profession that is truly dedicated to the care of the sick. Physicians' failure to understand the nature of suffering can result in medical intervention that (though technically adequate) not only fails to relieve suffering but becomes a source of suffering itself." -Eric J. Cassel [1] We must abandon those orientations that treat pain as an object independently of the being that it affects. -Giordano and Schatman [2]Early in their professional careers, virtually all physicians endeavor to practice medicine in an ethical manner motivated by a desire to help patients. It is also clear that a significant proportion of individuals and organizations involved in the delivery of health care in this country are centrally motivated by financial concerns. Our fee-for-service reimbursement system compensates for "doing things" to patients. Because of this, great attention must be applied to assure that medical care is focused on the patient's needs rather than that of the individual provider, their practice group, or a hospital system. Pain medicine, like most medical specialties, presents this challenge of maintaining patient-centered care. There are a variety of factors, patient-, provider-, and system-related, that can encourage overemphasis on maximization of financial reward. This type of practice, which is often procedurally focused (but also may occur in the form of inappropriate medical management, as exemplified by the "pill mills"), is inherently unethical and challenges the integrity of the field. Pain medicine must be multimodal and focused on doing what is in the best interest of the patient. The challenge over the next several years will be to utilize education and the coming changes in health care delivery to favor pain practice that is both ethical and sustainable. Case Reports Patient 1A 47-year-old woman (OC) presented for initial evaluation at a pain center with the chief complaint of persistent severe axial low back pain (LBP). OC was in a state of good health until 6 years prior, when this severe pain started after a strain

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Section: Patient 1 Discussionmentioning

confidence: 98%

Ethical Challenges and Interventional Pain Medicine

Brenner

Kueppenbender

Mao

et al. 2011

Curr Pain Headache Rep

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“…This situation will improve as physicians realize that their institutions (hospitals and other facilities) have a legal reporting requirement and should cooperate with manufacturers when they gather information as part of the MDR process. All health‐care providers performing or participating in SCS procedures should, therefore, familiarize themselves with these reporting requirements and with their institutional procedures for reporting adverse events to device manufacturers and/or the FDA (14).…”

Section: Discussionmentioning

confidence: 99%

“…We then sought to obtain accurate incidence and frequency data from reliable raw data that reside in the hands of the device manufacturers rather than merely in the public record. The manufacturers collect these data to comply with US Food and Drug Administration (FDA) requirements that a Medical Device Report (MDR) be sent to the FDA for every instance in which a medical device might have caused or contributed to death or serious injury or is likely to cause or contribute to a death or serious injury (14). A series of meetings between the first author and the presidents and representatives of the three manufacturers resulted in creation of a working group to develop an acceptable format for the collection and parsing of the data.…”

Section: Methodsmentioning

confidence: 99%

Incidence and Avoidance of Neurologic Complications with Paddle Type Spinal Cord Stimulation Leads

Levy

Henderson

Slavin

et al. 2011

Neuromodulation: Technology at the Neural Interface

124

115

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“…The mechanism of SQS-mediated paresthesia remains to be fully elucidated. However, it is thought that its effect arises from the creation of an electrical field that results in decreased nociceptive input which may impact on local blood flow, block cell membrane depolarization, and/or alter neurotransmitter release and reuptake, thus altering nociceptive information as it is transmitted to the central nervous system [11]. …”

Section: Introductionmentioning

confidence: 99%

Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial

Eldabe

Kern

Peul

et al. 2013

Trials

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BackgroundChronic radicular pain can be effectively treated with spinal cord stimulation, but this therapy is not always sufficient for chronic back pain. Subcutaneous nerve stimulation (SQS) refers to the placement of percutaneous leads in the subcutaneous tissue within the area of pain. Case series data show that failed back surgery syndrome (FBSS) patients experience clinically important levels of pain relief following SQS and may also reduce their levels of analgesic therapy and experience functional well-being. However, to date, there is no randomized controlled trial evidence to support the use of SQS in FBSS.Methods/DesignThe SubQStim study is a multicenter randomized controlled trial comparing SQS plus optimized medical management (‘SQS arm’) versus optimized medical management alone (‘OMM arm’) in patients with predominant back pain due to FBSS. Up to 400 patients will be recruited from approximately 33 centers in Europe and Australia and will be randomized 1:1 to the SQS or OMM arms. After 9 months, patients who fail to reach the primary outcome will be allowed to switch treatments. Patients will be evaluated at baseline (prior to randomization) and at 1, 3, 6, 9, 12, 18, 24, and 36 months after randomization. The primary outcome is the proportion of patients at 9 months with a ≥50% reduction in back pain intensity compared to baseline. The secondary outcomes are: back and leg pain intensity score, functional disability, health-related quality of life, patient satisfaction, patient global impression of change, healthcare resource utilization/costs, cost-effectiveness analysis and adverse events. Outcomes arms will be compared between SQS and OMM arms at all evaluation points up to and including 9 months. After the 9-month assessment visit, the main analytic focus will be to compare within patient changes in outcomes relative to baseline.DiscussionThe SubQStim trial began patient recruitment in November 2012. Recruitment is expected to close in late 2014.Trial registrationClinicalTrials.gov NCT01711619

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Differentiating the Leaves From the Branches in the Tree of Neuromodulation: The State of Peripheral Nerve Field Stimulation

Cited by 24 publications

References 23 publications

Ethical Challenges and Interventional Pain Medicine

Ethical Challenges and Interventional Pain Medicine

Incidence and Avoidance of Neurologic Complications with Paddle Type Spinal Cord Stimulation Leads

Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial

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