submit to the journals

Special Report—First Comprehensive Guidelines Published for Neurostimulation Therapy

US Neurology, 2014;10(2):122–4 DOI: http://doi.org/10.17925/USN.2014.10.02.122

Abstract:

Neuromodulation has a growing role in the management of chronic pain. An international panel of experts has reviewed the evidence and issued guidance regarding the appropriate use of neurostimulation. It is understood that a patient-centric cadence of progression through the pain care algorithm must be considered. Neurostimulation may offer long-term cost savings and improved functional status without complications from long-term opioid use. Indications for consideration of neurostimulation include failed back surgery syndrome, complex regional pain syndrome, peripheral neuropathic pain, chronic peripheral ischemic pain, and refractory angina pectoris. Criteria crucial for success include appropriate patient selection and education, proper use of sterile facilities, attentive follow-up by the healthcare team, and provider training.

Keywords: Chronic pain, practice guidelines, neuromodulation, spinal cord stimulation, consensus committee, advanced pain care, implantable technologies, pain management
Disclosure: Jason E Pope, MD, is a paid consultant for Flowonix Medical, Inc., Jazz Pharmaceuticals PLC, Mallinkrodt Pharmaceuticals, Medtronic, Inc., Spinal Modulation, Inc., and St Jude Medical, Inc. Stanley Golovac, MD, consults for Spinal Modulation, Inc., Spinal Restoration Inc., St Jude Medical, Inc., and Vertos Medical, Inc. Simon Thomson, MD, is on the advisory board and receives expenses and honoraria from Axonics Modulation Technologies, Inc. and Boston Scientific Corporation, and consults for the British Standards of Industry. Timothy R Deer, MD, consults for Axonics Modulation Technologies, Inc., Bioness, Inc., Flowonix Medical, Inc., Jazz Pharmaceuticals PLC, Medtronic, Inc., Nevro Corp., Spinal Modulation, Inc., and St Jude Medical, Inc. No funding was received for the publication of this article.
Received: September 26, 2014 Accepted: October 02, 2014
Correspondence: Jason E Pope, MD, Center for Pain Relief, 400 Court St, Ste. 100, Charleston, West Virginia 25301, US. E: popeje@me.com

Employing neuromodulation strategies to treat chronic pain has gained momentum in recent years, along with an expansion of the indications. These therapies are safe, reversible, and efficacious, improving both validated pain and functional measures. However, the trial procedure is not without risk and deserves a respectful assessment of the risks and the benefits associated with the therapy. Improving the outcomes, safety, and efficacy of employing neuromodulation is contingent on evaluating the evidence and expert opinion. This knowledge gap has been identified and addressed by the International Neuromodulation Society (INS).1

Convened by the INS, the Neuromodulation Appropriateness Consensus Committee (NACC) issued the first comprehensive peer-reviewed recommendations for appropriate use of neurostimulation in pain and ischemic disease in the August 2014 issue of Neuromodulation: Technology at the Neural Interface, the official journal of the INS.2–5 The major objective of this paper series was to create a living document, based on the best available evidence and expert opinion, which will be regularly updated to address the different applications, innovations, disease-specific indications, and patient selection criteria for the safe and appropriate use of neuromodulation.

Spinal cord stimulation has been in common clinical use since the 1980s and over 25,000 neurostimulators, sometimes described as a ‘pain pacemaker,’ are implanted worldwide each year to help reduce pain and restore function. Spinal cord stimulation for chronic back pain (failed back surgery syndrome) is the most common indication in the US. In Europe, peripheral nerve stimulation is also part of the physician’s armamentarium for intractable migraine, medication-resistant chronic angina pectoris, and chronic clinical leg ischemia.6 As device innovation continues to evolve, so to will the indications for neuromodulation therapies, expanding from the conventional use of spinal cord stimulation for failed back spinal surgeries and complex regional pain syndrome.

The comprehensive effort produced the current opinion as a consensus statement about available evidence on the use of neuromodulation to treat neuropathic pain, with an eye on future trends and indications. The guideline series describes the Appropriate Use of Neurostimulation of the Spinal Cord and Peripheral Nervous System for the Treatment of Chronic Pain and Ischemic Diseases; the Stimulation of the Intracranial and Extracranial Space and Head for Chronic Pain; a review and recommendation on the Avoidance and Treatment of Complications of Neurostimulation Therapies for the Treatment of Chronic Pain; and Neuromodulation New and Evolving Neurostimulation Therapies and Applicable Treatment for Chronic Pain and Selected Disease States.2–5

References:
  1. Deer TR, Thomson S, Pope JE, et al., International Neuromodulation Society Critical Assessment: Guideline Review of Implantable Neurostimulation Devices, Neuromodulation: Technology at the Neural Interface, 6 May 2014.
  2. Deer TR, Mekhail N, Provenzano D, et al., The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee, Neuromodulation, 2014;17:515–50.
  3. Deer TR, Mekhail N, Petersen E, et al., The appropriate use of neurostimulation: stimulation of the intracranial and extracranial space and head for chronic pain, Neuromodulation, 2014;17:551–70.
  4. Deer TR, Mekhail N, Provenzano D, et al., The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain, Neuromodulation, 2014;17:571–98.
  5. Deer TR, Krames E, Mekhail N, et al., The appropriate use of neurostimulation: new and evolving neurostimulation therapies and applicable treatment for chronic pain and selected disease states, Neuromodulation, 2014;17:599–615.
  6. Eisenberg E, Management of neuropathic pain, European Neurologic Review, 2006;2:20–3.
Keywords: Chronic pain, practice guidelines, neuromodulation, spinal cord stimulation, consensus committee, advanced pain care, implantable technologies, pain management