Appropriate referral and selection of patients with chronic pain for spinal cord stimulation: European consensus recommendations and e-health tool

Background: Spinal cord stimulation (SCS) is an established treatment for chronic neuropathic, neuropathic-like and ischaemic pain. However, the heterogeneity of patients in daily clinical practice makes it often challenging to determine which patients are eligible for this treatment, resulting in undesirable practice variations. This study aimed to establish patient-specific recommendations for referral and selection of SCS in chronic pain. Methods: A multidisciplinary European panel used the RAND/UCLA Appropriateness Method (RUAM) to assess the appropriateness of (referral for) SCS for 386 clinical scenarios in four pain areas: chronic low back pain and/or leg pain, complex regional pain syndrome, neuropathic pain syndromes and ischaemic pain syndromes. In addition, the panel identified a set of psychosocial factors that are relevant to the decision for SCS treatment. Results: Appropriateness of SCS was strongly determined by the neuropathic or neuropathic-like pain component, location and spread of pain, anatomic abnormalities and previous response to therapies targeting pain processing (e.g. nerve block). Psychosocial factors considered relevant for SCS selection were as follows: lack of engagement, dysfunctional coping, unrealistic expectations, inadequate daily activity level, problematic social support, secondary gain, psychological distress and unwillingness to reduce high-dose opioids. An educational e-health tool was developed that combines clinical and psychosocial factors into an advice on referral/selection for SCS. Conclusions: The RUAM was useful to establish a consensus on patient-specific criteria for referral/selection for SCS in chronic pain. The e-health tool may help physicians learn to apply an integrated approach of clinical and psychosocial factors. Significance: Determining the eligibility of SCS in patients with chronic pain requires careful consideration of a variety of clinical and psychosocial factors. Using a systematic approach to combine evidence from clinical studies and expert opinion, a multidisciplinary European expert panel developed detailed recommendations to support appropriate referral and selection for SCS in chronic pain. These recommendations are available as an educational e-health tool (https://www.scstool.org/)

Burst spinal cord stimulation in a patient with a cardiac pacemaker - Fattibilità dell’impianto di SCS con stimolazione Burst in un paziente con pacemaker cardiaco

A 74-year-old male suffering from neuropathic pain in the distal portion of the lower limbs had obtained no relief from medical treatments. Additional comorbidities included pacemaker-dependent complete (3rd degree) atrio-ventricular block and a prolactin-secreting adenoma of the pituitary gland. An electrocatheter was implanted in the epidural space, with the active leads spanning the T10-T11 vertebral levels. Intraoperative stimulation tests were performed in both tonic and burst modes while pacemaker activity was monitored in real time. SCS stimulation intensity was increased in steps up to the threshold of patient tolerability (7.5 mA tonic, 3.9 mA burst). Pacemaker sensitivity was set to the maximum (0.5 mV): during the procedure, no interference with pacemaker sensing was observed. To the authors' knowledge, this is the first case report on the feasibility of burst SCS in a pacemaker-dependent patient. The report suggests that burst stimulation is safe in such patients

Efficacy of high frequency spinal cord stimulation for the treatment of Buerger’s disease: a case report - Efficacia della stimolazione midollare ad alta frequenza per il trattamento del morbo di Buerger: caso clinico

SCS are used extensively in refractory peripheral artherosclerotic disease. The patient was a 50 year-old woman smoker affected by advanced Buerger’s disease with pain localized mostly in the distal extremities of lower limbs. Following the failure of different treatments we suggested performing SCS to obtain better pain control and better microcirculation. In 2009 the patient underwent SCS implantation and in May 2012, was found to have a decubitus ulcer in the area of the subcutaneous pocket. In October 2012 we implanted a high frequency SCS. We used a 10 cm VAS and ESAS Edmonton Symptoms Assessment Scale) to evaluate difference in quality of life, sleep, disability, pain relief and Patient Global Impression Scale (PGIS) to compare the patient’s satisfaction between treatments. The patient reported a significant improvement in pain reduction with both types of stimulators (tonic and high frequency). The quality of life improved more with the high frequency stimulation and the patient considers high frequency stimulation more effective than tonic stimulation. Our case report suggests that high frequency SCS can be a useful therapy for ischemic pain control

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Il concorso è diviso in due aree di intervento. La Makryanni Site posta ai piedi dell’Acropoli e la Dionysos Site. Nella prima viene collocato il museo dotato di un parcheggio sotterraneo per 400 posti: questo si riallaccia al vecchio complesso museale, attraverso un portico a due piani che richiama le architetture della Stoa e caratterizzato nella zona degli ingressi da un muro circolare che distribuisce alle varie sezioni. Due edifici funzionanao in maniera autonoma: una sala conferenze per 500 posti nella zona ovest del vecchio edificio e, nei pressi della collina, i laboratori. Nell’area di Dionysos il recupero di un edificio esistente a ristorante e punto informazioni permette la creazione di un parcheggio per 40 autobus per i turisti dell’Acropoli

Neurophysiological Comparison Among Tonic, High Frequency, and Burst Spinal Cord Stimulation: Novel Insights Into Spinal and Brain Mechanisms of Action

Spinal cord stimulation (SCS) is an effective option for neuropathic pain treatment. New technological developments, as high-frequency (HF) and theta burst stimulation (TBS), have shown promising results, although putative mechanisms of action still remain debated

Peripheral Nerve Stimulation in the Treatment of Chronic Pain Syndromes From Nerve Injury: A Multicenter Observational Study

IntroductionAssessing the feasibility, technical implications, and clinical benefits of peripheral nerve stimulation (PNS) performed by an implantable pulse generator (IPG) located close to the stimulation site.Materials and MethodsSelected patients were affected by neuropathic pain associated with a documented peripheral nerve lesion, refractory to conventional surgical or pharmacological treatment. A PNS system specifically designed for peripheral placement (Neurimpulse, Padova, Italy) was implanted and followed for six months, recording the degree of patient's satisfaction (PGI-I questionnaire), the pain numerical rating scale (NRS) and the quality of life (SF36 questionnaire), as well as any change in drug regimen and work capability. The statistical significance of differences was determined by the paired Student's t-test.ResultsA total of 58 patients were referred to permanent IPG implantation. Stimulation failure due to lead damage or dislocation was noticed in two cases (3.4%) in six months. At the follow-up end, the relative NRS reduction averaged -5830% (p<10(-6)) and was greater than 50% in 69% of the cases. Quality-of-life physical and mental indices were increased by 18% (p<0.005) and 29% (p<0.0005), respectively. The administration of antalgic drugs was stopped in 55% and reduced in 16% of the patients. Low-energy stimulation was possible in most cases, resulting in an IPG estimated life of 80 +/- 35 months.ConclusionsSuccessful PNS was achieved with a stimulation system designed for peripheral location. This new technology reduced the incidence of lead-related adverse events and the energy cost of the treatment.Introduction: Assessing the feasibility, technical implications, and clinical benefits of peripheral nerve stimulation (PNS) performed by an implantable pulse generator (IPG) located close to the stimulation site. Materials and Methods: Selected patients were affected by neuropathic pain associated with a documented peripheral nerve lesion, refractory to conventional surgical or pharmacological treatment. A PNS system specifically designed for peripheral placement (Neurimpulse, Padova, Italy) was implanted and followed for six months, recording the degree of patient's satisfaction (PGI-I questionnaire), the pain numerical rating scale (NRS) and the quality of life (SF36 questionnaire), as well as any change in drug regimen and work capability. The statistical significance of differences was determined by the paired Student's t-test. Results: A total of 58 patients were referred to permanent IPG implantation. Stimulation failure due to lead damage or dislocation was noticed in two cases (3.4%) in six months. At the follow-up end, the relative NRS reduction averaged â\u88\u9258 ± 30% (p < 10â\u88\u926) and was greater than 50% in 69% of the cases. Quality-of-life physical and mental indices were increased by 18% (p < 0.005) and 29% (p < 0.0005), respectively. The administration of antalgic drugs was stopped in 55% and reduced in 16% of the patients. Low-energy stimulation was possible in most cases, resulting in an IPG estimated life of 80 ± 35 months. Conclusions: Successful PNS was achieved with a stimulation system designed for peripheral location. This new technology reduced the incidence of lead-related adverse events and the energy cost of the treatment

Applicability and Validity of an e-Health Tool for the Appropriate Referral and Selection of Patients With Chronic Pain for Spinal Cord Stimulation: Results From a European Retrospective Study

Objectives: To support rational decision-making on spinal cord stimulation (SCS), a European expert panel developed an educational e-health tool using the RAND/University of California at Los Angeles Appropriateness Method. This retrospective study aimed to determine the applicability and validity of the tool using data from patients for whom SCS had been considered. Materials and Methods: A total of 12 European implant centers retrieved data from 25 to 50 consecutive patients for whom SCS was considered in 2018–2019. For each patient, data were captured on the clinical and psychosocial variables included in the e-health tool, center decisions on SCS, and patient outcomes. Patient outcomes included global perception of effect by the patient and observer, and pain reduction (numeric pain rating scale) at six-month follow-up. Results: In total, 483 patients were included, of whom 133 received a direct implant, 258 received an implant after a positive trial, 32 had a negative trial, and 60 did not receive SCS for reasons other than a negative trial. The most frequent indication was persistent spinal pain syndrome type 1 and type 2 (74%), followed by neuropathic pain syndromes (13%), complex regional pain syndrome (12%), and ischemic pain syndromes (0.8%). Data on the clinical and psychosocial variables were complete for 95% and 93% of patients, respectively, and missing data did not have a significant impact on the study outcomes. In patients who had received SCS, panel recommendations were significantly associated with patient outcomes (p < 0.001 for all measures). Substantial improvement ranged from 25% if the e-health tool outcome was “not recommended” to 83% if SCS was “strongly recommended”. In patients who underwent a trial (N = 290), there was 3% of trial failure when SCS was ”strongly recommended” vs 46% when SCS was ”not recommended”. Conclusions: Retrospective application of the e-health tool on patient data showed a strong relationship between the panel recommendations and both SCS trial results and treatment outcomes

Patient selection for spinal cord stimulation: The importance of an integrated assessment of clinical and psychosocial factors

Background : A previously developed educational e-health tool considers both clinical and psychosocial factors when selecting patients with chronic pain for spinal cord stimulation (SCS). The validity of the composite recommendations was evaluated in a retrospective study, demonstrating a strong relationship with patient outcomes after SCS. Methods : An additional retrospective analysis was performed to determine the added value of a psychosocial evaluation as part of the decision-making process on SCS. Data concerned 482 patients who were considered for SCS in 2018–2019. The analysis focused on the relationship between the different layers of the tool recommendations (clinical, psychosocial, composite) with trial results and patient outcomes at 6 months after SCS. Of the initial study population, 381 patients underwent SCS and had follow-up data on at least one of three pain-related outcome measures. Results : Pain improvement was observed in 76% of the patients for whom SCS was strongly recommended based on merely the clinical aspects. This percentage varied by the level of psychosocial problems and ranged from 86% in patients without any compromising psychosocial factors to 60% in those with severe problems. Similarly, the severity of psychosocial problems affected trial results in patients for whom SCS was either recommended or strongly recommended. Conclusions : The strong relationship between psychosocial factors embedded in the SCS e-health tool and patient outcomes supports an integrated and multidisciplinary approach in the selection of patients for SCS. The educational e-health tool, combining both clinical and psychosocial aspects, is believed to be helpful for further education and implementation of this approach. Significance statement: This study confirms the relevance of the psychosocial factors embedded in the educational SCS e-health tool (https://scstool.org/). The strong relationship between the severity of psychosocial factors with patient outcomes supports conducting a comprehensive psychological and behavioural assessment when determining the eligibility of patients for SCS