Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Good practice recommendations to better coordinate the management of oncological pain: a Delphi survey.

Treatment of oncological pain is complex and requires a multidisciplinary management approach between oncology services and pain units. Although significant improvements have been achieved in the treatment and overall survival of cancer patients, the management of oncological pain has not followed the same directions. Many patients are not referred to pain units even though they could benefit from it. The purpose of this Delphi survey was to map the current situation in the management of cancer pain, identify barriers and propose recommendations to improve its management by emphasizing the importance of collaboration and coordination between oncology services and pain units. A survey among members with recognized experience in the management of oncology patients and oncological pain was held based on the Delphi method principles. The experts were asked to vote preselected statements on cancer pain management in two rounds and conclusions and recommendations were formulated based on the consensus reached for each statement. Barriers and areas for improvement were identified: need of multidisciplinary management approach, effective communication between oncology services and pain units, timely referral of cancer patients to pain units, training of health care professionals dealing with cancer aspects and identification of those patients that could benefit from a multidisciplinary management of their oncological disease. The experts issued recommendations targeting the identified barriers and areas for improvement by defining the service requirements of hospital and units treating cancer pain patients, establishing referral pathways necessities and adopted measures to improve the care of cancer patients.

A Delphi Study on the Management of Neuropathic Cancer Pain in Spain: The DOLNEO Study.

Purpose: The objectives of this project were to assess the current situation and management of cancer-related neuropathic pain (CRNP) in Spain and to provide specific recommendations for the assessment, diagnosis and treatment of CRNP using a Delphi methodology. Methods: This was a qualitative study that followed a Delphi methodology using a questionnaire with 56 statements that were grouped into 5 areas related to CRNP: prevalence and impact, pathophysiology, assessment and diagnosis, specific syndromes, treatment, and multidisciplinary approach. Based on the responses, the scientific committee prepared an algorithm and a recommended pathway for the management of CRNP. Results: Seventy-nine physicians attended the meeting and completed the questionnaire. Consensus was reached for all statements relating to the prevalence and impact of CRNP. However, the perceptions of specialists from palliative care of the frequency and impact of CRNP differed from those of other specialists. A high degree of consensus was reached for all statements concerning the assessment and diagnosis of CRNP. Regarding specific syndromes, the only statement with a lack of consensus was that on the frequency of NP in patients undergoing radiotherapy. There were some disagreements regarding the multidisciplinary approach and referral criteria for the management of NP. Conclusion: Our results show a large degree of agreement on the assessment, diagnosis and treatment of cancer-related neuropathic pain among the specialists involved in its management. There were, however, some disagreements regarding the multidisciplinary approach and referral criteria for the management of neuropathic pain.

Update on Interventional Management of Neuropathic Pain: A Delphi Consensus of the Spanish Pain Society Neuropathic Pain Task Force.

Background and Objectives: Interventional management of neuropathic pain (NP) is available to the patients who do not obtain satisfactory pain relief with pharmacotherapy. Evidence supporting this is sparse and fragmented. We attempted to summarize and critically appraise the existing data to identify strategies that yield the greatest benefit, guide clinicians, and identify areas that merit further investigation. Material and Methods: A two-round Delphi survey that involved pain clinic specialists with experience in the research and management of NP was done over an ad hoc 26-item questionnaire made by the authors. Consensus on each statement was defined as either at least 80% endorsement or rejection after the 2nd round. Results: Thirty-five and 29 panelists participated in the 1st and 2nd round, respectively. Consensus was reached in 20 out of 26 statements. There is sufficient basis to treat postherpetic neuralgias and complex regional pain syndromes with progressive levels of invasiveness and failed back surgery syndrome with neuromodulation. Radiculopathies and localized NP can be treated with peripheral blocks, neuromodulation, or pulsed radiofrequency. Non-ablative radiofrequency and non-paresthetic neuromodulation are efficacious and better tolerated than ablative and suprathreshold procedures. Conclusions: A graded approach, from least to most invasive interventions has the potential to improve outcomes in many patients with common refractory NP conditions. Preliminary promising data warrant further research on new indications, and technical advances might enhance the safety and efficacy of current and future therapies.

Real-World Cost-Effectiveness Analysis of Spinal Cord Stimulation vs Conventional Therapy in the Management of Failed Back Surgery Syndrome.

PURPOSE: Failed back surgery syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to conventional medical management (CMM) and spinal cord stimulation (SCS) is advised. However, comparative cost-effectiveness research of both clinical approaches still lacks further evidence. This probabilistic cost-effectiveness analysis compares CMM versus SCS plus CMM in FBSS patients for a 5-year period in Spain. PATIENTS AND METHODS: Patient-level data was obtained from a 2-year real-world study (SEFUDOCE) of adults diagnosed with FBSS who were treated with CMM or SCS. Incremental cost-effectiveness ratios (ICER) were estimated in terms of direct clinical cost and quality-adjusted life years (QALYs). Costs (€ for 2019) were estimated from the Spanish National Health Service (NHS) perspective. We applied a yearly discount rate of 3% to both costs and outcomes and performed a probabilistic sensitivity analysis using bootstrapping. RESULTS: After 2 years, the health-related quality of life measured by the EQ-5D displayed greater improvements for SCS patients (00.39) than for improved CMM patients (0.01). The proportion of SCS patients using medication fell substantially, particularly for opioids (-49%). In the statistical model projection, compared with the CMM group at year 5, the SCS group showed an incremental cost of € 15,406 for an incremental gain of 0.56 0.56 QALYs, for an ICER of € 27,330, below the €30,000 willingness-to-pay threshold for Spain. SCS had a 79% of probability of being cost-effective. CONCLUSION: SCS is a cost-effective treatment for FBSS compared to CMM alone based on real-world evidence.

Novedades en el tratamiento del dolor de espalda: ¿son el futuro las terapias celulares? / News in the treatment of back pain: are the future cell therapies?

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Prevalence and characterization of breakthrough pain in patients with cancer in Spain: the CARPE-DIO study.

We aimed to evaluate the prevalence, characteristics and impact of breakthrough pain (BTP) in patients with cancer attending the main specialties involved in the diagnosis and management of BTP in Spain using a multicenter, observational, cross-sectional, multidisciplinary study. Investigators had to record all patients seen at the clinic during 1 month, determine whether the patients had cancer pain, and apply the Davies algorithm to ascertain whether the patients were suffering from BTP. Of the 3,765 patients with cancer, 1,117 (30%) had cancer-related pain, and of these patients, 539 had BTP (48%, 95%CI:45-51). The highest prevalence was found in patients from palliative care (61%, 95%CI:54-68), and the lowest was found in those from hematology (25%, 95%CI:20-31). Prevalence varied also according to sex and type of tumor. According to the Alberta Breakthrough Pain Assessment Tool duration, timing, frequency, location, severity, quality, causes, and predictability of the BTP varied greatly among these patients. BTP was moderate (Brief Pain Inventory [BPI]-severity median score = 5.3), and pain interference was moderate (BPI-interference median score = 6.1) with a greater interference with normal work, general activity, and enjoyment of life. Patients with BTP showed a mean ± standard deviation score of 28.5 ± 8.0 and 36.9 ± 9.5 in the physical and mental component, respectively, of the SF-12 questionnaire. In conclusion, prevalence of BTP among patients exhibiting cancer-related pain is high. Clinical presentation is heterogeneous, and therefore, BTP cannot be considered as a single entity. However, uniformly BTP has an important impact on a patient's functionality, which supports the need for early detection and treatment.

Opioides y adicción en dolor crónico: ¿es un problema?, ¿cómo abordarlo? / Celiac axis block in cancer pain: medicine of opportunity

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Aclaraciones sobre el artículo "Recomendaciones basadas en la evidencia para el manejo del dolor neuropático (revisión de la literatura)" / Explanations on the article "Recommendations based on evidence for the management of neuropathic pain (review of the literature)"

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Observational Study Evaluating the Economic Impact of Breakthrough Pain in Cancer Patients in Clinical Practice in Spain: The IMDI Study.

INTRODUCTION: Breakthrough pain (BTP) has great repercussions on the quality of life, and on the use of health resources. The scope of BTP costs in cancer patients is unknown. The purpose of this study was to evaluate the economic cost of BTP in patients with cancer and the relationship with their quality of life. METHODS: A 1-month observational prospective cost-of-illness study was designed. The patients recorded the consumption of health resources and drugs related to BTP in a diary. The current symptoms in Edmonton Symptoms Assessment Scale (ESAS) and their quality of life (EORTC QLQ-C30, version 3) were assessed. The direct medical and non-medical costs fixed and variable and the indirect costs of the patient and the caregivers were evaluated. Factors related to cost and quality of life were identified using linear generalized models (LGM) type gamma and logistic link. Participants were oncologic patients with BTP, older than 18 years, with controlled basal pain. RESULTS: Eight Spanish pain units, eight palliative care units, and one oncology department included 152 patients. One hundred patients (65.8%) were male and the mean age was 66.8 years (95% CI 64.8-68.8). The total cost per patient was 2941.60 euros per month: 88% direct medical costs, 5% non-medical direct costs, and 7% indirect costs due to lost productivity. A better score in EORTC QLQ-30 quality of life was associated with a reduction in overall costs. CONCLUSIONS: The study showed the results of the first real-life prospective study evaluating the cost of illness of BTP in cancer patients demonstrating that the presence of breakthrough pain in a cancer patient causes a very significant increase in healthcare costs. FUNDING: Kyowa Kirin Farmacéutica, S.L.U.

Diagnostic accuracy of an identification tool for localized neuropathic pain based on the IASP criteria.

OBJECTIVE: Based on the clear neuroanatomical delineation of many neuropathic pain (NP) symptoms, a simple tool for performing a short structured clinical encounter based on the IASP diagnostic criteria was developed to identify NP. This study evaluated its accuracy and usefulness. METHODS: A case-control study was performed in 19 pain clinics within Spain. A pain clinician used the experimental screening tool (the index test, IT) to assign the descriptions of non-neuropathic (nNP), non-localized neuropathic (nLNP), and localized neuropathic (LNP) to the patients' pain conditions. The reference standard was a formal clinical diagnosis provided by another pain clinician. The accuracy of the IT was compared with that of the Douleur Neuropathique en 4 questions (DN4) and the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS). RESULTS: Six-hundred and sixty-six patients were analyzed. There was a good agreement between the IT and the reference standard (kappa =0.722). The IT was accurate in distinguishing between LNP and nLNP (83.2% sensitivity, 88.2% specificity), between LNP and the other pain categories (nLNP + nNP) (80.0% sensitivity, 90.7% specificity), and between NP and nNP (95.5% sensitivity, 89.1% specificity). The accuracy in distinguishing between NP and nNP was comparable with that of the DN4 and the LANSS. The IT took a median of 10 min to complete. CONCLUSIONS: A novel instrument based on an operationalization of the IASP criteria can not only discern between LNP and nLNP, but also provide a high level of diagnostic certainty about the presence of NP after a short clinical encounter.

Most Relevant Neuropathic Pain Treatment and Chronic Low Back Pain Management Guidelines: A Change Pain Latin America Advisory Panel Consensus.

Objective: Chronic pain conditions profoundly affect the daily living of a significant number of people and are a major economic and social burden, particularly in developing countries. The Change Pain Latin America (CPLA) advisory panel aimed to identify the most appropriate guidelines for the treatment of neuropathic pain (NP) and chronic low back pain (CLBP) for use across Latin America. Methods: Published systematic reviews or practice guidelines were identified by a systematic search of PubMed, the Guidelines Clearinghouse, and Google. Articles were screened by an independent reviewer, and potential candidate guidelines were selected for more in-depth review. A shortlist of suitable guidelines was selected and critically evaluated by the CPLA advisory panel. Results: Searches identified 674 and 604 guideline articles for NP and CLBP, respectively. Of these, 14 guidelines were shortlisted for consensus consideration, with the following final selections made: "Recommendations for the pharmacological management of neuropathic pain from the Neuropathic Pain Special Interest Group in 2015-pharmacotherapy for neuropathic pain in adults: A systematic review and meta-analysis.""Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society" (2007). Conclusions: The selected guidelines were endorsed by all members of the CPLA advisory board as the best fit for use across Latin America. In addition, regional considerations were discussed and recorded. We have included this expert local insight and advice to enhance the implementation of each guideline across all Latin American countries.

Managing chronic pain in elderly patients requires a CHANGE of approach.

In many countries, the number of elderly people has increased rapidly in recent years and this is expected to continue; it has been predicted that almost a quarter of the population in the European Union will be over 65 years of age in 2035. Many elderly people suffer from chronic pain but it is regularly under-treated, partly because managing these patients is often complex. This paper outlines the extent of untreated pain in this population and the consequent reduction in quality of life, before articulating the reasons why it is poorly or inaccurately diagnosed. These include the patient's unwillingness to complain, atypical pain presentations, multiple morbidities and cognitive decline. Successful pain management depends upon accurate diagnosis, which is based upon a complete history and thorough physical examination, as well as an assessment of psychosocial functioning. Poor physician/patient communication can be improved by using standardized instruments to establish individual treatment targets and measure progress towards them. User-friendly observational instruments may be valuable for patients with dementia. In line with the widely accepted biopsychosocial model of pain, a multidisciplinary approach to pain management is recommended, with pharmacotherapy, psychological support, physical rehabilitation and interventional procedures available if required. Declining organ function and other physiological changes require lower initial doses of analgesics and less frequent dosing intervals, and the physician must be aware of all medications that the patient is taking, in order to avoid drug/drug interactions. Non-adherence to treatment is common, and various strategies can be employed to improve it; involving the elderly patient's caregivers and family, using medication systems such as pill-boxes, or even sending text messages. In the long term, the teaching of pain medicine needs to be improved--particularly in the use of opioids--both at undergraduate level and after qualification.

The development of chronic pain: physiological CHANGE necessitates a multidisciplinary approach to treatment.

Chronic pain is currently under-diagnosed and under-treated, partly because doctors' training in pain management is often inadequate. This situation looks certain to become worse with the rapidly increasing elderly population unless there is a wider adoption of best pain management practice. This paper reviews current knowledge of the development of chronic pain and the multidisciplinary team approach to pain therapy. The individual topics covered include nociceptive and neuropathic pain, peripheral sensitization, central sensitization, the definition and diagnosis of chronic pain, the biopsychosocial model of pain and the multidisciplinary approach to pain management. This last section includes an example of the implementation of a multidisciplinary approach in Belgium and describes the various benefits it offers; for example, the early multidimensional diagnosis of chronic pain and rapid initiation of evidence-based therapy based on an individual treatment plan. The patient also receives continuity of care, while pain relief is accompanied by improvements in physical functioning, quality of life and emotional stress. Other benefits include decreases in catastrophizing, self-reported patient disability, and depression. Improved training in pain management is clearly needed, starting with the undergraduate medical curriculum, and this review is intended to encourage further study by those who manage patients with chronic pain.

The chronic pain conundrum: should we CHANGE from relying on past history to assessing prognostic factors?

BACKGROUND: Despite limited empirical support, chronic pain has traditionally been defined mainly on the basis of its duration, which takes no account of the causative mechanisms or its clinical significance. SCOPE: For this commentary on current pain management practice, the CHANGE PAIN Advisory Board considered the evidence for adopting a prognostic definition of chronic pain. The rationale underlying this approach is to take psychological and behavioural factors into account, as well as the multidimensional nature of pain. Measures of pain intensity, interference with everyday activities, role disability, depression, duration and number of pain sites are used to calculate a risk score, which indicates the likelihood of a patient having pain in the future. The consistency of a prognostic definition with the concept of integrated patient care was also considered. FINDINGS: When this method was compared with the number of pain days experienced over the previous 6 months--in patients with back pain, headache or orofacial pain--it was a better predictor of clinically significant pain 6 months later for all three pain conditions. Further evidence supporting this approach is that several factors other than the duration of pain have been shown to be important prognostic indicators, including unemployment, functional disability, anxiety and self-rated health. The use of a multifactorial risk score may also suggest specific measures to improve outcomes, such as addressing emotional distress. These measures should be undertaken as part of an integrated pain management strategy; chronic pain is a biopsychosocial phenomenon and all aspects of the patient's pain must be dealt with appropriately and simultaneously for treatment to be effective. CONCLUSION: The implementation of a prognostic definition and wider adoption of integrated care could bring significant advantages. However, these measures require improved training in pain management and structural revision of specialist facilities, for which political support is essential.

The association of pain with labor force participation, absenteeism, and presenteeism in Spain.

OBJECTIVES: The aims of this paper are to generate estimates of the association between the severity and frequency of pain in Spain and (i) labor force participation and workforce status and (ii) patterns of absenteeism and presenteeism for the employed workforce. METHODS: Data are from the internet-based 2010 National Health and Wellness Survey (NHWS). This survey covers both those who report experiencing pain in the last month as well as the no-pain population. An estimated 17.25% of adults in Spain report experiencing pain in the past month. A series of regression models are developed with the no-pain group as the reference category. The impact of pain, categorized by severity and frequency, is assessed within a labor supply framework for (i) labor force participation and (ii) absenteeism and presenteeism. Both binomial and multinomial logistic models are estimated. RESULTS: The results demonstrate that severe and moderate pain has a significant, substantive, and negative association with labor force participation and, together with the experience of mild pain, a substantive impact on absenteeism and presenteeism within the employed workforce. Compared to no-pain controls, the strongest association is seen in the case of severe pain, notably severe daily pain and labor force participation (odds ratio 0.363; 95% CI: 0.206-0.637). The association of severe pain with labor force participation is also significant (odds ratio 0.356; 95% CI: 0.217-0.585). There is a clear gradient in the association of pain severity and frequency with labor force participation. The impact of pain is far greater than the potential impact of other health status measures (e.g., chronic comorbidities and BMI). Labor force participation is also adversely associated with pain experience. Persons reporting severe daily pain are far more likely not to be in the labor force (relative probabilities 0.339 vs 0.611). The experience of pain, notably severe and frequent pain, also outstrips the impact of other health status factors in absenteeism and presenteeism. In the former case, the odds ratio associated with severe daily pain is 16.216 (95% CI: 5.127-51.283), which contrasts to the odds ratio for the Charlson comorbidity index of 1.460 (95%CI: 1.279-1.666). Similar results hold for presenteeism. The contribution of moderate and mild pain to absenteeism and presenteeism is more marked than for labor force participation. CONCLUSIONS: The experience of pain, in particular severe daily pain, has a substantial negative impact both on labor force participation in Spain as well as reported absenteeism and presenteeism. As a measure of health status, it clearly has an impact that outstrips other health status measures. Whether or not pain is considered as a disease in its own right, the experience of chronic pain, as defined here, presents policy-makers with a major challenge. Programs to relieve the burden of pain in the community clearly have the potential for substantial benefits from societal, individual, and employer perspectives.

Pain, health related quality of life and healthcare resource utilization in Spain.

OBJECTIVES: The aim of this paper is to consider the relationship between the experience of pain, health related quality of life (HRQoL) and healthcare resource utilization in Spain. METHODS: The analysis contrasts the contribution of pain severity and frequency of pain reported against respondents reporting no pain in the previous month. Data are from the 2010 National Health and Wellness Survey (NHWS) for Spain. Single equation generalized linear regression models are used to evaluate the association of pain with the physical and mental component scores of the SF-12 questionnaire as well as health utilities generated from the SF-6D. In addition, the role of pain is assessed in its association with self-reported healthcare provider visits, emergency room visits and hospitalizations in the previous 6 months. RESULTS: The results indicate that the experience of pain, notably severe and frequent pain, is substantial and is significantly associated with the SF-12 physical component scores, health utilities and all aspects of healthcare resource utilization, which far outweighs the role of demographic and socioeconomic variables, health risk factors (in particular body mass index) and the presence of comorbidities. In the case of severe daily pain, the marginal contribution of the SF-12 physical component score is a deficit of -17.86 compared to those reporting no pain (population average score 46.49), while persons who are morbidly obese report a deficit of only -6.63 compared to those who are normal weight. The corresponding association with health utilities is equally dramatic with a severe daily pain deficit of -0.186 compared to those reporting no pain (average population utility 0.71). The impact of pain on healthcare resource utilization is marked. Severe daily pain increases traditional provider visits by 208.8%, emergency room visits by 373.0% and hospitalizations by 348.5%. LIMITATIONS: As an internet-based survey there is the possibility of bias towards those with internet access, although telephone sampling is used to supplement responses. Respondents are asked to describe their experience of pain; there is no independent check on the accuracy of responses. Finally, while certain acute pain categories are omitted, the study focuses on pain in the last month and not on pain chronicity. CONCLUSIONS: The societal burden of severe and frequent pain in Spain is substantial. Although not reported on before, at a national level, the deficit impact of the experience of pain far outweighs the contribution of more traditional explanations of HRQoL deficits as well as being the primary factor associated with increased provider visits, emergency room visits and hospitalizations.

An inhalation bolus of sevoflurane versus an intravenous bolus of remifentanil for controlling hemodynamic responses to surgical stress during major surgery: a prospective randomized trial.

UNLABELLED: We studied 120 patients scheduled for elective major thoracic or abdominal surgery, randomized into 2 groups: a Sevoflurane group (n = 63) and a Remifentanil group (n = 57). Heart rate (HR) and mean arterial pressure (MAP) are indicative of sympathetic response to surgical stress. A positive response was defined as a 15% increase in the HR and MAP above baseline measurements. When a positive response occurred, in the Sevoflurane group we administered a bolus dose of 8% sevoflurane (fresh gas flow 6 L/min) and in the Remifentanil group, an IV bolus dose of remifentanil 1 microg x kg(-1) x min(-1), which was maintained until MAP and HR returned to baseline measurements (effective bolus). If, after a bolus dose, a decrease in MAP and/or HR of >15% occurred with respect to baseline values, the response was considered to be excessive. The bolus dose was ineffective in 4.8% of the responses in the Sevoflurane group and in 17.8% of the responses in the Remifentanil group (P < 0.05). In the Sevoflurane group, an excessive effect occurred in 12% of responses, and in 26.7% in the Remifentanil group (P < 0.05). An inhalation bolus of sevoflurane seems to be more effective than an IV remifentanil bolus during maintenance, with more effective control of hemodynamic responses to surgical stress. IMPLICATIONS: We compared an inhalation bolus of sevoflurane with remifentanil for managing hemodynamic responses to major abdominal or thoracic surgery. This prospective, randomized trial demonstrated better results with sevoflurane.