Holistic Treatment Response: An International Expert Panel Definition and Criteria for a New Paradigm in the Assessment of Clinical Outcomes of Spinal Cord Stimulation.

BACKGROUND: Treatment response to spinal cord stimulation (SCS) is focused on the magnitude of effects on pain intensity. However, chronic pain is a multidimensional condition that may affect individuals in different ways and as such it seems reductionist to evaluate treatment response based solely on a unidimensional measure such as pain intensity. AIM: The aim of this article is to add to a framework started by IMMPACT for assessing the wider health impact of treatment with SCS for people with chronic pain, a "holistic treatment response". DISCUSSION: Several aspects need consideration in the assessment of a holistic treatment response. SCS device data and how it relates to patient outcomes, is essential to improve the understanding of the different types of SCS, improve patient selection, long-term clinical outcomes, and reproducibility of findings. The outcomes to include in the evaluation of a holistic treatment response need to consider clinical relevance for patients and clinicians. Assessment of the holistic response combines two key concepts of patient assessment: (1) patients level of baseline (pre-treatment) unmet need across a range of health domains; (2) demonstration of patient-relevant improvements in these health domains with treatment. The minimal clinical important difference (MCID) is an established approach to reflect changes after a clinical intervention that are meaningful for the patient and can be used to identify treatment response to each individual domain. A holistic treatment response needs to account for MCIDs in all domains of importance for which the patient presents dysfunctional scores pre-treatment. The number of domains included in a holistic treatment response may vary and should be considered on an individual basis. Physiologic confirmation of therapy delivery and utilisation should be included as part of the evaluation of a holistic treatment response and is essential to advance the field of SCS and increase transparency and reproducibility of the findings.

Is the introduction of another variable to the strength-duration curve necessary in neurostimulation?

INTRODUCTION: Neurostimulation is the process and technology derived from the application of electricity with different parameters to activate or inhibit nerve pathways. Pulse width (Pw) is the duration of each electrical impulse and, along with amplitude (I), determines the total energy charge of the stimulation. OBJECTIVES: The aim of the study was to test Pw values to find the most adequate pulse widths in rechargeable systems to obtain the largest coverage of the painful area, the most comfortable paresthesia, and the greatest patient satisfaction. MATERIAL AND METHODS: A study of the parameters was performed, varying Pw while maintaining a fixed frequency at 50 Hz. Data on perception threshold (Tp ), discomfort threshold (Td ), and therapeutic threshold (Tt ) were recorded, applying 14 increasing Pw values ranging from 50 µsec to 1000 µsec. Lastly, the behavior of the therapeutic range (TR), the coverage of the painful area, the subjective patient perception of paresthesia, and the degree of patient satisfaction were assessed. RESULTS: The findings after analyzing the different thresholds were as follows: When varying the Pw, the differences obtained at each threshold (Tp , Tt , and Td ) were statistically significant (p < 0.05). The differences among the resulting Tp values and among the resulting Tt values were statistically significant when varying Pw from 50 up to 600 µsec (p < 0.05). For Pw levels 600 µsec and up, no differences were observed in these thresholds. In the case of Td , significant differences existed as Pw increased from 50 to 700 µsec (p ≤ 0.05). The coverage increased in a statistically significant way (p < 0.05) from Pw values of 50 µsec to 300 µsec. Good or very good subjective perception was shown at about Pw 300 µsec. CONCLUSIONS: The patient paresthesia coverage was introduced as an extra variable in the chronaxie-rheobase curve, allowing the adjustment of Pw values for optimal programming. The coverage of the patient against the current chronaxie-rheobase formula will be represented on three axes; an extra axis (z) will appear, multiplying each combination of Pw value and amplitude by the percentage of coverage corresponding to those values. Using this new comparison of chronaxie-rheobase curve vs. coverage, maximum Pw values will be obtained different from those obtained by classic methods.

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.

INTRODUCTION: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. METHODS: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. RESULTS: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device-related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. CONCLUSIONS: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.

The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain. Neuromodulation Appropriateness Consensus Committee.

INTRODUCTION: The International Neuromodulation Society (INS) has determined that there is a need for guidance regarding safety and risk reduction for implantable neurostimulation devices. The INS convened an international committee of experts in the field to explore the evidence and clinical experience regarding safety, risks, and steps to risk reduction to improve outcomes. METHODS: The Neuromodulation Appropriateness Consensus Committee (NACC) reviewed the world literature in English by searching MEDLINE, PubMed, and Google Scholar to evaluate the evidence for ways to reduce risks of neurostimulation therapies. This evidence, obtained from the relevant literature, and clinical experience obtained from the convened consensus panel were used to make final recommendations on improving safety and reducing risks. RESULTS: The NACC determined that the ability to reduce risk associated with the use of neurostimulation devices is a valuable goal and possible with best practice. The NACC has recommended several practice modifications that will lead to improved care. The NACC also sets out the minimum training standards necessary to become an implanting physician. CONCLUSIONS: The NACC has identified the possibility of improving patient care and safety through practice modification. We recommend that all implanting physicians review this guidance and consider adapting their practice accordingly.

Subcutaneous stimulation: how to assess optimal implantation depth.

INTRODUCTION: Subcutaneous stimulation (peripheral nerve field stimulation) is a novel neuromodulation modality that has increased in its utilization during the last 10 years. It consists of introducing a lead in the subdermal level to stimulate the small nerve fibers in that layer. Unlike other neuromodulation techniques including direct peripheral nerve stimulation, spinal cord stimulation, or deep brain stimulation, the precise target is not identified. MATERIALS AND METHODS: To date, there is no clear guideline on the appropriate depth or a method to achieve reproducibility of the appropriate depth to place these leads. From clinical experience, we have found that when electrodes are placed in a layer that is too superficial, stimulation is often painful or lacks efficacy. Further, if they are too deep, the patient may not feel adequate paresthesia or get uncomfortable stimulation including, in some circumstances, muscle contractions. RESULTS: In this small series, we demonstrate a novel concept using a radiofrequency stimulation probe to identify the appropriate depth to place the lead. Reproducibility of results will add clarity to the accumulating data and hopefully increase the chances of adequate stimulation coverage and pain relief.

Peripheral nerve stimulation: definition.

Recently, there has been a tremendous evolution in the field of neurostimulation, both from the technological point of view and from development of the new and different indications. In some areas, such as peripheral nerve stimulation, there has been a boom in recent years due to the variations in the surgical technique and the improved results documented by in multiple published papers. All this makes imperative the need to classify and define the different types of stimulation that are used today. The confusion arises when attempting to describe peripheral nerve stimulation and subcutaneous stimulation. Peripheral nerve stimulation, in its pure definition, involves implanting a lead on a nerve, with the aim to produce paresthesia along the entire trajectory of the stimulated nerve.

Is impedance a parameter to be taken into account in spinal cord stimulation?

BACKGROUND: Over the last few decades, spinal cord stimulation (SCS) has become one of the main treatments in the therapeutic arsenal available to pain treatment units. New stimulation systems have been developed and the indications of neurostimulation have been expanded. The premises for a successful technique remain the same; good patient selection, good surgical technique, and good management of electrical parameters when programming. DESIGN: An observational report. OBJECTIVES: The primary objective of the study was to determine the relationship between changes in impedance (R) and energy requirement (E) elicited by changes in patients posture. The postures analyzed were supine (S), sitting (SI), standing (ST), and walking (W). As a second objective, the difference produced in the energy requirement when changing posture was analyzed. METHODS: A study was carried out in 70 patients with chronic intractable pain implanted with a neurostimulation system between January 2000 and March 2006. We define the perception threshold (Tp); the discomfort threshold (Td); and the therapeutic threshold (Tt). The amplitude of perception was measured in mA. With the resulting data, the therapeutic range (TR) was determined. After performing all measurements with the patient in the ST position, the neurostimulation system was shut off and the patient maintained in the other position for 5 minutes before performing the measurements. The variables R and E were compared by age groups, sex, implant duration, and the time since implant placement. Patients were divided into groups according to whether the location of the implanted electrodes was cervical or thoracic. The full analysis by age, sex, and implant duration was performed in the cervical and thoracic implant groups. RESULTS: No correlation was found between impedance and posture. When the results for R and E were analyzed by sex and age, no statistical differences were found in any of the values in any position. The analysis of time since implant greater than or less than 6 months did not find differences in the energy requirement, although there was a significant difference in the impedance value when patients were in the S position. No significant differences were observed in the analysis by age groups.