Reflecting groundbreaking international consensus regarding a group of rapidly evolving medical interventions for chronic pain, the International Neuromodulation Society (INS) announced it will soon publish the first peer-reviewed comprehensive expert guidance on the appropriate use of neurostimulation for pain.
Neurostimulation is a minimally invasive, reversible therapy that delivers highly focused electrical stimulation to the brain, spinal cord and peripheral nerves to decrease chronic pain symptoms, help restore function, and improve quality of life in appropriately selected patients. Over 25,000 neurostimulators, sometimes described as a "pain pacemaker," are implanted worldwide each year.
The INS Board of Directors recognized the need to better define the appropriate use of these advanced tools, and appointed experts to the Neuromodulation Appropriateness Consensus Committee (NACC) to review and assess the quality of the scientific and medical literature. The first spinal cord neurostimulator was implanted in an attempt to decrease pain in 1967. By the 1980s, spinal cord stimulation (SCS) for intractable pain was popularized; with regular technological advancements and clinical experience, neurostimulation techniques continue to evolve. The consensus committee considered research data and expert opinion published between 1984 and 2013; where high quality evidence was lacking, they supplemented the guidelines with their extensive clinical experience. Although less comprehensive guidelines have been published in the past, they have quickly become obsolete as the field has evolved. These earlier guidelines were recently reviewed in the INS's journal, Neuromodulation: Technology at the Neural Interface.
Unlike these prior attempts, the NACC will remain a current, living document, evolving with regular updates as new information becomes available.
As a result of this consensus process, the work product of the NACC will be published in four peer-reviewed articles co-authored by 60 neuromodulation experts in the August 2014 issue of Neuromodulation: Technology at the Neural Interface. The four articles will present a comprehensive discussion of the appropriate uses of SCS and other neuromodulation therapies. They will discuss neurostimulation risk management, complication avoidance and treatment as well as recommendations for the appropriate education, training and environments for neurostimulation procedures. A separate discussion will focus on neurostimulation procedures of the head and brain, including the treatment of intractable migraine and cluster headaches. Finally, they will examine cutting edge and future technologic developments, new devices and future potential applications of neurostimulation.
These guidelines were prepared in a format to allow for regular periodic updates, and are intended to help make sense of the wide-ranging scientific literature for both newer and more-experienced practitioners. The formation of the NACC was modeled after the Polyanalgesic Consensus Conference, which has issued guidelines in 2000, 2003, 2007 and 2012 regarding the use of intrathecal drug delivery systems for chronic pain conditions.
The NACC recommends, for example, consideration of neurostimulation for chronic pain patients in whom conservative treatment fails to yield acceptable relief with reasonable efforts or creates unmanageable side effects. In some cases this will mean moving neurostimulation earlier in the treatment continuum. The authors cite published research studies, for instance, that indicate spinal cord stimulation should be used before reoperation in failed back surgery syndrome and before starting long-term, systemic administration of long-acting opioids.
In another consensus opinion, the notion that 50 percent pain relief is required for a successful neurostimulation trial was brought into question for some specific applications. The co-authors recommend, for example, that for chronic, medication-resistant migraine headaches, a 30 percent improvement in symptoms should be considered a successful trial in that this degree of improvement has been shown to improve function and quality of life for these patients. This is especially the case in that they have few if any other options to treat these recurrent disabling episodes.
The expert panel also recommends that all permanent implants be performed in a full medical facility rather than an office or clinic setting unless it meets the same sterile-environment standards as an accredited hospital or surgery center. Furthermore, they recommend that implanters have hospital-admission privileges, perform no less than 10 supervised implantations during training, monitor their outcomes and quality indicators, and perform a high volume of implant procedures to keep their skills up-to-date.
"As technologies progress and indications expand, practice guidelines help physicians assimilate and apply new knowledge about efficiency, efficacy and safety so they may exercise their best clinical judgment about existing and emerging medical interventions," said Timothy Deer, MD, Chairman of the NACC, President-Elect of the INS, and scientific committee chair of the society's 12th World Congress in June 2015, "Neuromodulation: Medicine Evolving Through Technology".
"We believe that securing access to neurostimulation treatments for selected patients with chronic pain administered by appropriately trained practitioners is an important challenge to all health economies," said Simon Thomson, MBBS, FFPMRCA, President of the INS. "An expert consensus should help to avoid issues of underuse, overuse, or misuse."
With continued development and refinement of neurostimulation technologies, the NACC foresees continued improvement in safety, efficacy and cost effectiveness as devices become smaller, more robust and specialized to specific applications, while the knowledge base continues to grow and physicians' experience and skills expand.
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