The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Best Practices for Cervical Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based upon their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.

Updated management of occipital nerve stimulator lead migration: case report of a technical challenge.

Electrode migration is a challenge, even with adequate anchoring techniques, due to the high mechanical stress on components of occipital nerve stimulation (ONS) for headache disorders. When a lead displacement of an ONS implant is diagnosed, there are currently different approaches described for its management. Nevertheless current neuromodulation devices are designed like a continuum of components without any intermediate connector, and if a lead displacement is diagnosed, the solution is the complete removal of the electrode from its placement, and its repositioning through an ex-novo procedure. The described technique can allow ONS leads to be revised while minimizing the need to reopen incisions over the IPG, thus improving patients' intraoperative and postoperative discomfort, shortening surgical time and medical costs, reasonably reducing the incidence of infective postoperative complications.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

Vulvodynia--An Evidence-Based Literature Review and Proposed Treatment Algorithm.

OBJECTIVE: We searched the medical literature from the last 15 years (1998 to 2013) relating to the etiology, diagnosis, and treatment of vulvodynia. The evidence was reviewed supporting the therapeutic proposals currently in use and propose the incorporation of novel, minimally invasive, interventional therapies, within the context of a multidisciplinary approach. METHODS: This was a systematic review of all relevant studies with no language restrictions. Studies were identified through Medline/PubMed (1998 to March 2013), the Cochrane Library (2001 to 2013), and conference records and book chapters. The keywords used included "chronic pelvic pain," "vulvodynia," "vestibulodynia," and search terms "etiology," "diagnosis," and "treatment" were added. The levels of evidence were assessed using grading system for "Therapy/Prevention/Etiology/Harm" developed by the Centre for Evidence-Based Medicine (CEBM). The grading system assists in clinical decision-making, and we decided to use "The Grading of Recommendations Assessment, Development, and Evaluation (GRADE)." RESULTS: A total of 391 papers were assessed. Of these, 215 were analyzed and 175 were excluded, as they pertained to areas not directly related to the disease under review. CONCLUSION: The optimal therapy for vulvar pain syndrome remains elusive, with low percentages of therapeutic success, using either local or systemic pharmacological approaches. Surgery involving invasive and often irreversible therapeutic procedures has resulted in success for certain subtypes of vulvodynia. We present a multidisciplinary approach whereby pain treatment units may provide an intermediate level of care between standard medical and surgical treatments.

Chronic Low Back Pain: Restoration of Dynamic Stability.

OBJECTIVES: Electrical stimulation for multifidus muscle contraction is a novel approach for treating chronic low back pain (CLBP). A multicenter, open-label feasibility study investigated this modality in patients with continuing CLBP despite medical management and no prior back surgery and no known pathological cause of CLBP. METHODS: Twenty-six patients with continuing CLBP despite physical therapy and medication were implanted with commercially-available implantable pulse generators and leads positioned adjacent to the medial branch of the dorsal ramus as it crosses the L3 transverse process such that electrical stimulation resulted in contraction of the lumbar multifidus (LM) muscle. Patients self-administered stimulation twice daily for 20 min. Low back pain (VAS), Oswestry Disability Index (ODI) and Quality of Life (EQ-5D) scores were collected at three and five months and compared to baseline. Stimulation was withdrawn between months 4 and 5 to test durability of effect. RESULTS: At three months, 74% of patients met or exceeded the minimally important change (MIC) in VAS and 63% for disability. QoL improved in 84% of patients (N = 19) and none got worse. Five of the 11 patients on disability for CLBP (45%) resumed work by three months. Half the patients reported ≥50% VAS reduction by month 5. Twenty-one lead migration events occurred in 13 patients, of which 7 patients are included in the efficacy cohort. CONCLUSIONS: Episodic stimulation to induce LM contraction can reduce CLBP and disability, improve quality of life and enable return to work. A dedicated lead design to reduce risk of migration is required.

Hemodynamic impact of isobaric levobupivacaine versus hyperbaric bupivacaine for subarachnoid anesthesia in patients aged 65 and older undergoing hip surgery.

BACKGROUND: The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, observational pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus hyperbaric bupivacaine for hip fracture surgery. DESCRIPTION: Hundred twenty ASA status I-IV patients aged 65 and older undergoing hip fracture surgery were enrolled. The primary objective of our study was to compare hemodynamic effects based on systolic blood pressure (SBP) and dyastolic blood pressure (DBP) values, heart rate (HR) and hemoglobin (Hb) and respiratory effects based on partial oxygen saturation (SpO2%) values. The secondary objective was to assess potential adverse events with the use of levobupivacaine versus bupivacaine. Assessments were performed preoperatively, at 30 minutes into surgery, at the end of anesthesia and at 48 hours and 6 months after surgery. Among intraoperative events, the incidence of hypotension was statistically significantly higher (p <0.05) in group BUPI (38.3%) compared to group LEVO (13.3%). There was a decrease (p <0.05) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 30 minutes intraoperatively (19% in group BUPI versus 17% in group LEVO). SpO2% increased at 30 minutes after anesthesia onset (1% in group BUPI versus 1.5% in group LEVO). Heart rate (HR) decreased at 30 minutes after anesthesia onset (5% in group BUPI versus 9% in group L). Hemoglobin (Hb) decreased from time of operating room (OR) admission to the end of anesthesia (9.3% in group BUPI versus 12.5% in group LEVO). The incidence of red blood cell (RBC) transfusion was 13.3% in group BUPI versus 31.7% in group LEVO, this difference was statistically significant. Among postoperative events, the incidence of congestive heart failure (CHF) was significantly higher in group BUPI (8,3%). At 6 months after anesthesia, no differences were found. CONCLUSIONS: Given the hemodynamic stability and lower incidence of intraoperative hypotension observed, levobupivacaine could be the agent of choice for subarachnoid anesthesia in elderly patients.

Peripheral subcutaneous vulvar stimulation in the management of severe and refractory vulvodynia.

BACKGROUND: Vulvodynia is a complex and multifactorial clinical condition with severe pain that occurs in the absence of visible infectious, inflammatory, neoplastic, or neurological findings. CASE: A 35-year-old woman with 3 years of dysesthetic vulvodynia tried conventional and interventional medical treatment with inadequate relief. She was offered peripheral subcutaneous vulvar field stimulation and underwent implantation of two vulvar subcutaneous electrodes. At 15 days after treatment and during 1-year follow-up, the patient scored 1 out of 15 on Friedrich scale, 1 out of 10 on the visual analog scale, and 1 out of 10 on the tampon test. The patient no longer requires oral medication. CONCLUSION: Stimulation with subcutaneous electrodes provided relief from vulvodynia to a patient in whom all previous therapeutic approaches had failed.

Spinal cord stimulation for the treatment of Buerger disease: a report on 3 cases.

OBJECTIVES: Buerger disease (or thromboangeiitis obliterans) is an inflammatory disease of the medium and small caliber arteries and veins that predominantly affects young males and presents with ischemia in the hands or the feet. It is closely associated with smoking. Critical ischemia of the lower limbs is a threat to the survival of the patient s extremities, and often disables its victims severely. This takes on an even greater significance in younger individuals who are still actively employed, as is the case in patients suffering from Buerger disease. Our aim was to evaluate the efficiency of the spinal cord stimulation as an alternative therapeutic option in acute stages of Buerger disease. RESULTS AND METHODS: We present a case series of males under the age of 45 years, diagnosed with thromboangeiitis obliterans and all of them were in the acute phase of the disease. They were satisfactorily treated with an implantable spinal cord stimulation device. DISCUSSION: Spinal cord stimulation is an accepted therapy for the treatment of chronic ischemic pain and ulcer healing and to avoid amputation in patients with severe, nonrevascularisable peripheral occlusive arteriopathy, and specially in the subgroup of patients with Buerger disease. It should not only be considered as a last resort strategy for pain control, but as a valid therapeutic option to improve perfusion of the limbs in the initial stages of the disease, however larger studies still remain necessary.

Use of a spinal cord stimulator for treatment of Martorell hypertensive ulcer.

Martorell ulcer is a specific disease entity characterized by multiple small homogeneous, symmetrical lesions, although single lesions are observed as well, most commonly located on the anterolateral aspect of the lower leg. The pain associated to these lesions is disproportionate to their size.Martorell ulcer designates a specific disease entity that occurs predominantly in middle-aged women with poorly controlled hypertension in the form of skin ulcers on the anterolateral aspect of the lower legs. The lesions initially appear as small, painful blisters which may or may not be associated with trauma. The pathophysiology of Martorell ulcer is assumed to be related to hypertension-induced arteriole changes in the dermis. The pain is often disproportionate, and the symptoms are not relieved by rest or elevation.Spinal cord stimulation (SCS) is an accepted evidence-based therapy for the treatment of chronic ischemic pain. Spinal cord stimulation is used as a therapeutic tool in the management of this disease not only for symptomatic pain control but also for accelerating the healing process through its effects on causal mechanisms. The beneficial effects of SCS when used to treat ischemic pain include pain relief, decreased infarction or ulcer size, decreased oxygen requirements, and increased claudication distance. Clinical and basic studies indicate that these beneficial effects are mainly associated with an increase or redistribution of blood flow to the ischemic area and/or normalization of the activity in the nervous system.We present the case of a 71-year-old woman diagnosed with Martorell ulcer in the acute phase of the disease. The patient was treated with SCS to achieve both pain relief and healing of the cutaneous ulcer.

A double-blind, controlled, randomized trial to evaluate the efficacy of botulinum toxin for the treatment of lumbar myofascial pain in humans.

BACKGROUND: Among all the causes of chronic low back pain, myofascial pain syndrome of the spinal stabilizer muscles is one of the most frequent, yet underconsidered sources of pain. The purpose of this prospective, randomized, double-blind, controlled trial was to evaluate the efficacy of type-A botulinum toxin (BTX-A) in relieving myofascial pain in patients experiencing mechanical low back pain due to bilateral myofascial pain syndrome involving the iliopsoas and/or the quadratus lumborum muscles. METHODS: Each of the 27 enrolled patients received a bilateral, fluoroscopically guided injection in the affected muscle(s) to randomly deliver BTX-A in one side of the low back and a control drug (randomly constituted by NaCl 0.9% or bupivacaine 0.25%) in the opposite side. To evaluate the effects of treatment on daily life activities and psychologic status, 5 different questionnaires were administered (Hospital Anxiety and Depression scale [HAD-A and HAD-D], Lattinen, Oswestry, and Spielberger State-Trait Anxiety Index). RESULTS: BTX-A injection did not significantly reduce visual analog scale scores more than treatment with NaCl or bupivacaine in the contralateral side; furthermore, the treatments administered did not result in a significant improvement of patients' daily life activities or psychologic status. Although a trend toward a decrease in postintervention visual analog scale scores could be recognized in all low back sides, this trend was significant only in the sides treated with BTX-A. CONCLUSIONS: BTX-A seems to provide significant postintervention pain relief. However, considering its high cost and the small differences compared with control treatments, its use should be reserved only for patients with pain refractory to other invasive treatments.

The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study.

BACKGROUND: Spinal cord stimulation is an effective therapy for chronic, neuropathic pain refractory to medication. Use of a rechargeable neurostimulation system (Restore, Medtronic Inc) could provide greater longevity in the treatment of complex pain. However, patients' ability to successfully recharge a neurostimulation system has not yet been demonstrated. PRIMARY OBJECTIVE: Ability of patients to recharge the neurostimulator. SECONDARY OBJECTIVES: Patient and physician satisfaction with the system, pain relief, quality of life, functional status, adverse events. METHODS: Prospective, open-label, multicenter, European study in patients with long-term refractory neuropathic pain. Recharging ability was assessed 1-month postimplant. Patient and physician satisfaction, pain relief, quality of life, and functional status were assessed at scheduled follow-up visits through 12 months. Adverse events were monitored throughout. RESULTS: Primary end point: 100% of patients (n=41) successfully recharged the neurostimulator. Secondary end points at 1 month: 78.6% of patients found recharging easy. At 12 months: physicians were satisfied with the system for 92.7% of patients; pain intensity decreased significantly (P<0.001); mean self-reported pain relief was 62%; 80.5% of patients had more than 50% pain relief; quality of life and functional status improved significantly (P<0.001); 98% of patients would recommend spinal cord stimulation to others. Overall, 41 device-related complications (23 patients) were observed. CONCLUSIONS: Twelve-month experience indicates that the rechargeable neurostimulation system (Restore) was easy to use, with 100% of patients able to recharge successfully. Patient and physician satisfaction was high, with significant improvements in pain, quality of life, and functional status. Complications were comparable to prior experience with this therapy.

Peripheral neurostimulation in supraorbital neuralgia refractory to conventional therapy.

Supraorbital neuralgia has been identified as an infrequent cause of headache that may prove very difficult to control pharmacologically. Peripheral nerve stimulation using electrodes to stimulate the nerve segmentally responsible for the zone of pain may constitute a management alternative in such cases. We present the case of a patient with headache because of posttraumatic supraorbital neuralgia, refractory to medical treatment, with good analgesic control after peripheral nerve stimulation. Peripheral nerve stimulation may be considered a safe, reversible treatment for patients with headache secondary to supraorbital neuralgia who respond poorly to pharmacological treatment, thus avoiding irreversible alternatives such as surgery.

The beneficial effect of spinal cord stimulation in a patient with severe cerebral ischemia and upper extremity ischemic pain.

Spinal cord stimulation (SCS) is used in the treatment of chronic pain, ischemia because of obstructive arterial disease, and anginal pain. Recently, a number of studies have described the effects of the high cervical SCS, including increased cerebral blood flow, although the underlying mechanisms are unknown. This case report describes a patient with a severe complex ischemic condition affecting both cerebral and upper limb blood flow with an associated complex regional pain syndrome in upper limb. While all previous clinical treatments proved ineffective, cervical SCS afforded satisfactory results. Possible mechanisms underlying the cervical SCS effect are discussed.

Magnetic resonance imaging in patients with spinal neurostimulation systems.

BACKGROUND: The safety of performing magnetic resonance imaging (MRI) in patients with spinal cord stimulation (SCS) systems needs to be documented. A prospective in vivo study in patients with SCS, exploring the changes produced by MRI and the associated side effects, was performed. METHODS: After ethics committee approval and patient consent, 31 consecutive patients with SCS at different spinal levels requiring a scheduled MRI evaluation were studied during an 18-month period. All MRIs were performed with a 1.5-T clinical use magnet and a specific absorption rate of no more than 0.9 W/kg. Frequency tables were used for the descriptive study, whereas comparative evaluations were made with the chi-square test for qualitative variables and single-factor analysis of variance for quantitative variables. RESULTS: The mean patient age was 49 +/- 9.5 yr; 67.7% were women (n = 21), and 32.3% were men (n = 10). None of the patients experienced hemodynamic, respiratory, or neurologic alterations. Reported changes were as follows: increased temperature in the generator's area (n = 2, 6.5%); increased in the intensity of the stimulation (n = 1, 3.2%); impedance greater than 4,000 Omega on several of the electrodes in the leads (n = 1, 3.2%); telemetry not possible (n = 2, 6.5%). Radiologic evaluation after MRI revealed no spatial displacements of the SCS leads in any case. CONCLUSION: Under the conditions of the described protocol, MRI in patients with SCS systems resulted in few complications. None of the recorded problems were serious, and in no case were patients harmed or the systems reprogrammed. Maximum patient satisfaction was reported in all cases.

Neural modulation by stimulation.

Spinal cord stimulation (SCS) for the treatment of neuropathic pain is supported by good-quality randomized controlled trials, prospective and retrospective case studies, and observational case series that confirm its efficacy and safety. SCS has been successfully used in various refractory neuropathic pain conditions, including failed back surgery syndrome (FBSS), neuropathic back and leg pain, and complex regional pain syndrome (CRPS) types I and II. According to the Harbour and Miller Scale (2001), the evidence for SCS in FBSS has been classified as grade B, while that for CRPS type I has been classified as grade A. Clinical evidence has shown that compared to conventional pain therapy, more than two-thirds of carefully selected patients treated with SCS achieved sustained pain relief of 50% or more, with minimal side effects. Many patients were able to reduce their analgesic consumption. Quality of life improved and the majority of patients were happy with their treatment; in some cases, patients were able to return to work. Trial stimulation, which is relatively inexpensive and completely reversible, provides predictive value for long-term efficacy and increases the cost-effectiveness of permanent implantation. Studies consistently report that over time, SCS is potentially cost saving to the healthcare system. At present, SCS is considered a "last resort" in the treatment of refractory neuropathic pain, yet evidence suggests that early intervention with SCS results in greater efficacy and, in the case of FBSS, should be considered before re-operation.

New advances in botulinum toxin therapy for pain.

Myofascial pain syndrome is a chronic pain syndrome that affects a focal or regional portion of the body, accompanied by manifestations of neuropathy. The main treatment goal is to desensitize supersensitive structures and restore motion and function, releasing muscle shortening and promoting healing. Therapeutic approach include MTP injections using botulinum toxin type A and stretch, treatment of psychological or behavioral abnormalities, physical therapy, electrical stimulation and massage. Spasticity is defined as a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks resulting from hyperexcitability of the stretch reflex. This physiological events resulted in uncontrolled reflex activity (spasms) and increased muscle tone (rigidity). When used as part of an integrated antispasticity program, the dose of botulinum toxin type A may be adjusted to provide the precise degree of weakness needed to overcome spasticity, while preserving some strength for normal function. The benefits botulinum toxin type A can offer any particular patient depend on the location and degree of spasticity, but improvements in daily activities are usually obtained. In conclusion, botulinum toxin is currently an alternative to consider in the treatment of pain associated with myofascial pain syndrome and/or spasticity, based on a correct diagnosis and patient schedule program.