Incidence and Prevalence of Pain Medication Prescriptions in Pathologies with a Potential for Chronic Pain.

BACKGROUND: Heightened risks of dependence, addiction, anxiolytic effects, or prescription overdose death due to long-term use of pain medication have increased awareness about extended pain medication use in chronic pain populations. The goal of this study was to evaluate the incidence and prevalence of pain medication prescriptions from 2012 to 2022 in common pathologies with a potential for chronic pain. METHODS: A retrospective cohort study was conducted using electronic health records from TriNetX (Cambridge, Massachusetts) Global Collaborative Network. For 10 distinct cohorts (total n = 9,357,584 patients), pain medication prescriptions were extracted for five classes, namely nonsteroidal anti-inflammatory drug (NSAIDs) and acetaminophen, opioids, gabapentinoids, neuropathic mood agents, and muscle relaxants. Annual incidence and prevalence of each class of medication were evaluated for the past 11 yr. RESULTS: From 2012 to 2022, there was a significant increase in prescriptions of NSAIDs, except for patients with fibromyalgia, and persistent spinal pain syndrome (PSPS) type 2. Interestingly, over time, prescriptions of opioids in patients with complex regional pain syndrome, endometriosis, osteoarthritis, and PSPS type 2 increased, as did prescriptions of muscle relaxants for all cohorts except those with fibromyalgia. Incidence of prescriptions of neuropathic mood agents is high for patients with complex regional pain syndrome (both types) and PSPS type 2. Only for benzodiazepines did there seem to be a decline over the years, with a significantly decreased time trend in patients with complex regional pain syndrome type 1, fibromyalgia, and PSPS type 2. CONCLUSIONS: During the last 11 yr, an increase in incidence of NSAIDs and acetaminophen, opioids, neuropathic agents, and muscle relaxants was observed. Only prescriptions of benzodiazepines significantly decreased over time in specific cohorts. Overall, patients with PSPS type 2 and complex regional pain syndrome (both types) consume a broad variety of pain medication classes.

Effectiveness of pain medication tapering in chronic pain patients: a systematic review and meta-analysis.

BACKGROUND: This systematic review and meta-analysis aimed to inventory all outcome measures that are affected by tapering in chronic noncancer pain and to investigate the effectiveness of tapering. METHODS: A literature search was conducted from inception to April 2024 in MEDLINE via PubMed, Web of Science, SCOPUS, EMBASE, and PsycINFO. RESULTS: The initial database search identified 3969 articles, which were screened by two independent reviewers. Studies evaluating pain medication tapering in adults with chronic noncancer pain were eligible for inclusion. In total, 57 and 34 articles were included in the systematic review and meta-analysis, respectively. Risk of bias assessment demonstrated poor, fair, and good quality in 30, 24, and three studies, respectively. Pain intensity was the most reported outcome measure, as reported in 28 studies. Furthermore, a random-effect three-level meta-analysis was performed. An overall effect size of 0.917 (95% confidence interval 0.61-1.22; P<0.001) was found, indicating a beneficial effect of tapering. In addition, a statistically significant improvement was demonstrated after tapering for pain intensity, headache disability, the number of headache days per month, anxiety, depression, the number of pills consumed per month, the number of days with medication intake per month, pain catastrophising, and pain interference. No statistically significant effect was observed for physical functioning, mental health-related quality of life, opioid use, pain self-efficacy, and physical health-related quality of life. CONCLUSIONS: This systematic review revealed a broad range of outcome measures affected by tapering. Owing to the high risk of bias of the included articles, the results of this meta-analysis must be interpreted with caution. SYSTEMATIC REVIEW PROTOCOL: CRD42023416343 (PROSPERO).

Examining the Type, Quality, and Content of Web-Based Information for People With Chronic Pain Interested in Spinal Cord Stimulation: Social Listening Study.

BACKGROUND: The increased availability of web-based medical information has encouraged patients with chronic pain to seek health care information from multiple sources, such as consultation with health care providers combined with web-based information. The type and quality of information that is available on the web is very heterogeneous, in terms of content, reliability, and trustworthiness. To date, no studies have evaluated what information is available about neuromodulation on the web for patients with chronic pain. OBJECTIVE: This study aims to explore the type, quality, and content of web-based information regarding spinal cord stimulation (SCS) for chronic pain that is freely available and targeted at health care consumers. METHODS: The social listening tool Awario was used to search Facebook (Meta Platforms, Inc), Twitter (Twitter, Inc), YouTube (Google LLC), Instagram (Meta Platforms, Inc), blogs, and the web for suitable hits with "pain" and "neuromodulation" as keywords. Quality appraisal of the extracted information was performed using the DISCERN instrument. A thematic analysis through inductive coding was conducted. RESULTS: The initial search identified 2174 entries, of which 630 (28.98%) entries were eventually withheld, which could be categorized as web pages, including news and blogs (114/630, 18.1%); Reddit (Reddit, Inc) posts (32/630, 5.1%); Vimeo (Vimeo, Inc) hits (38/630, 6%); or YouTube (Google LLC) hits (446/630, 70.8%). Most posts originated in the United States (519/630, 82.4%). Regarding the content of information, 66.2% (383/579) of the entries discussed (fully discussed or partially discussed) how SCS works. In total, 55.6% (322/579) of the entries did not elaborate on the fact that there may be >1 potential treatment choice and 47.7% (276/579) did not discuss the influence of SCS on the overall quality of life. The inductive coding revealed 4 main themes. The first theme of pain and the burden of pain (1274/8886, 14.34% coding references) explained about pain, pain management, individual impact of pain, and patient experiences. The second theme included neuromodulation as a treatment approach (3258/8886, 36.66% coding references), incorporating the background on neuromodulation, patient-centered care, SCS therapy, and risks. Third, several device-related aspects (1722/8886, 19.38% coding references) were presented. As a final theme, patient benefits and testimonials of treatment with SCS (2632/8886, 29.62% coding references) were revealed with subthemes regarding patient benefits, eligibility, and testimonials and expectations. CONCLUSIONS: Health care consumers have access to web-based information about SCS, where details about the surgical procedures, the type of material, working mechanisms, risks, patient expectations, testimonials, and the potential benefits of this therapy are discussed. The reliability, trustworthiness, and correctness of web-based sources should be carefully considered before automatically relying on the content.

The Opinion of Healthcare Professionals About a Proposed European Registry of Neuromodulation for Chronic Pain: An Online Survey.

INTRODUCTION: During the last decade, the complementary value of real-world data (through registries or medical records) and data from randomized clinical trials has been recognized as increasingly important. In the field of neuromodulation, only a few industry-independent nationwide neuromodulation registries are available. The interest in creating a European registry has increased but without a successful result. The goal of this online survey is to gain further insights into the need for and burden of a European registry for neuromodulation. MATERIALS AND METHODS: An online survey was developed and distributed during the 3rd Joint Congress of the International Neuromodulation Society European Chapters in September 2023 (Hamburg, Germany). Healthcare professionals were asked to indicate the need for a European registry, the items that should be collected, and the restrictions to access of a European registry. RESULTS: In total, 125 respondents opened the link to the survey, of whom 104 completed (at least partly) the survey. Of the 104 responses, 91% indicated that there is a need for a European registry, whereas 6% indicated there is no need. The main reasons for establishing a registry on a European level were the possibility of collecting real-world evidence (84%), the potential to collect big data from European patients (82%), to evaluate safety in neuromodulation (70%), and the possibility of reporting yearly on European activity in neuromodulation (51%). Indications for neuromodulation, patient characteristics, and follow-up assessments were most often stated as items that should be collected. Access should not only be granted to implanters but also to nurses, the assessment team, and other physicians, as agreed on by 64%, 52%, and 51%, respectively. DISCUSSION: More than 90% of the respondents believed that a European registry for neuromodulation is needed, mainly to obtain real-world (big) data about the effectiveness and safety of this therapy. This survey clearly pointed to the need for a European registry for which it seems key to ensure financial and logistical support, in addition to in-depth legal guidance in developing this registry.

Socioeconomic Determinants of Initiating Neuromodulation for Chronic Pain: A Systematic Review.

OBJECTIVES: Neuromodulation is an effective treatment for chronic pain; however, socioeconomic differences may influence decision-making to initiate this therapy. This review investigated potential differences in accessibility of neuromodulation for patients with chronic pain due to socioeconomic determinants. MATERIALS AND METHODS: Four electronic databases were used for this systematic review: MEDLINE, Embase, Scopus, and Web of Science. Risk of bias was assessed using the modified version of the Downs and Black checklist. The study protocol was prospectively registered on PROSPERO (CRD42023426035). RESULTS: The initial database search identified a total of 1118 unique studies, of which 36 were eventually included in the systematic review. Of the 36 included studies, six studies reported on education, 24 on employment status, ten on insurance, five on household income, and three on miscellaneous topics. Neuromodulation seems accessible for patients with different education levels and different types of insurance. Additionally, it is not restricted to patients who are (un)employed. When comparing patients who initiated neuromodulation with those who did not, a significantly higher number of patients in the top quartile for education were found in the group without neuromodulation. Regarding insurance, inconclusive evidence was found. CONCLUSIONS: Although neuromodulation was accessible for patients with varying levels of socioeconomic determinants, disparities were noted. When comparing the socioeconomic profiles of patients who receive neuromodulation and those who do not, education levels differ. Health-related inequality should be carefully monitored in chronic pain management with neuromodulation to ensure that potential disparities do not increase.

Impact of fatigue on anaesthesia providers: a scoping review.

BACKGROUND: Recently, fatigue has received more attention as a workplace hazard. This scoping review focuses on fatigue in anaesthesia providers. We explore the prevalence of fatigue in anaesthesia providers, and we examine how fatigue impacts their performance. METHODS: A literature search was independently conducted from December 2019 through March 2020. The following four databases were consulted: MEDLINE, CINAHL, EMBASE, and PubPsych. Only studies discussing fatigue in anaesthesia providers were eligible. RESULTS: The initial database search identified a total of 118 studies, of which 30 studies were included in the review. Eight articles concerned the prevalence of fatigue in anaesthesia providers, whereas 22 explored the impact of fatigue on the performance of anaesthesia providers. Up to 60.8% of anaesthesia providers suffered from severe excessive daytime sleepiness, and fatigue was denoted as a common workplace problem in up to 73.1% of anaesthesia providers. Fatigue had a negative influence on medication errors and vigilance, and it decreased the performance of anaesthesia providers during laboratory psychomotor testing. There was a decrease in non-technical skills (notably communication and teamwork) and worsening mood when fatigued. CONCLUSIONS: Based on this scoping review, fatigue is a prevalent a phenomenon that anaesthesia providers cannot ignore. A combination of deterioration in non-technical skills, increased medication errors, loss of sustained attention, and psychomotor decline can lead to poorer performance and cause patient harm. Concrete strategies to mitigate fatigue should be developed.

Effect of perioperative pain neuroscience education in people undergoing surgery for lumbar radiculopathy: a multicentre randomised controlled trial.

BACKGROUND: Perioperative education should be improved to decrease unfavourable outcomes after lumbar surgery. This trial aimed to compare effectiveness in terms of pain, quality of life, pain cognition, surgical experience, healthcare use, work resumption, and cost-effectiveness of perioperative pain neuroscience education (PPNE) vs traditional biomedical education (perioperative biomedical education [PBE]) in people undergoing surgery for lumbar radiculopathy. METHODS: In this multicentre RCT (ClinicalTrials.gov: NCT02630732), patients undergoing surgery for lumbar radiculopathy in three Belgian hospitals were randomised to receive PPNE or PBE. Both groups received one preoperative and one postoperative one-to-one education session and a booklet (balanced interventions), with an essentially different content (PPNE: biopsychosocial; PBE: biomedical). Pain was the primary outcome (Visual Analogue Scales+quantitative sensory testing). Assessments were at 3 days, 6 weeks, and 6 and 12 months after surgery. RESULTS: Between March 2016 and April 2020, participants were randomly assigned to PPNE (n=58) or PBE (n=62). At 12 months, PPNE did not lead to significantly better pain outcomes, but it did result in more favourable 36-item Short Form Health Survey physical component (additional increase: 46.94; 95% confidence interval [CI]: 14.16-79.73; medium effect), Tampa Scale of Kinesiophobia (additional decrease: 3.15; 95% CI: 0.25-6.04; small effect), and Pain Catastrophising Scale (additional decrease: 6.18; 95% CI: 1.97-10.39; medium effect) scores. Females of the PPNE group showed higher probability for work resumption (95% vs 60% in the PBE group). PPNE was cost-effective compared with PBE (incremental costs: €-2732; incremental quality-adjusted life years: 0.012). CONCLUSIONS: Perioperative pain neuroscience education showed superior clinical and cost-effectiveness than perioperative biomedical education in people undergoing surgery for lumbar radiculopathy. CLINICAL TRIAL REGISTRATION: NCT02630732.

Experimental Pain Measurements Do Not Relate to Pain Intensity and Pain Cognitions in People Scheduled for Surgery for Lumbar Radiculopathy.

OBJECTIVE: The present cross-sectional study aims to unravel associations of pain intensity and cognitions with quantitative sensory testing in people scheduled for surgery for lumbar radiculopathy. Additionally, insight will be provided into the presence of dysfunctional nociceptive processing and maladaptive pain cognitions in this population. DESIGN: Cross-sectional study. SETTING: Data from three hospitals in Belgium. SUBJECTS: The final sample comprised 120 participants with lumbar radiculopathy scheduled for surgery, included between March 2016 and April 2019. METHODS: Self-reported pain intensity was assessed on a visual analog scale, and pain cognitions were assessed with self-reported questionnaires (Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, and Pain Vigilance and Awareness Questionnaire). Quantitative sensory testing (detection thresholds, pain thresholds, temporal summation, and conditioned pain modulation) was evaluated, as well. RESULTS: Evidence was found for the presence of an impaired inhibitory response to nociceptive stimuli and maladaptive pain cognitions in this population. Kinesiophobia was found to be present to a maladaptive degree in the majority of the patients (n = 106 [88%]). Significant, but weak, associations between electrical pain thresholds at the sural nerves and leg pain intensity (sural nerve symptomatic side: r = -0.23; P = 0.01; non-symptomatic side: r = -0.22; P = 0.02) and kinesiophobia levels (sural nerve non-symptomatic side: r = -0.26; P = 0.006) were identified. CONCLUSIONS: Electrical detection thresholds and correlates for endogenous nociceptive facilitation and inhibition were not found to be related to any of the pain cognitions or to pain intensity in people scheduled to undergo surgery for lumbar radiculopathy.

Incidence of Infections, Explantations, and Displacements/Mechanical Complications of Spinal Cord Stimulation During the Past Eight Years.

OBJECTIVES: The overall awareness and potential of real-world data have drastically increased in the medical field, with potential implications for postmarket medical device surveillance. The goal of this study was to evaluate real-world data on incidence of infections, explantations, and displacements/mechanical complications of spinal cord stimulation (SCS) during the past eight years and to forecast point estimates for the upcoming three years on the basis of the identified patterns. MATERIALS AND METHODS: Based on electronic health records from 80 healthcare organizations within the TriNetX data base in the USA, data of 11,934 patients who received SCS as treatment for persistent spinal pain syndrome type 2 (PSPS T2) were extracted. Events of interest were explantations and displacements/mechanical complications of both the lead and implanted pulse generator (IPG), in addition to infection rates from 2015 to 2022. Mann-Kendall tests were performed to detect monotonic trends in the time series. Forecasts were conducted for the upcoming three years for every event of interest. RESULTS: Statistically significant increasing time trends were revealed for the annual incidence of IPG and lead displacements/mechanical complications in patients with PSPS T2 over the past eight years. These time trends were visible in both male and female patients and in smokers and nonsmokers. For annual incidence of explantations and infections, no significant time effect was observed. In 2025, the incidence of displacements/mechanical complications of the lead (3.07%) is predicted to be the highest, followed by explantations of the IPG (2.67%) and lead (2.02%). CONCLUSIONS: Based on real world data, device explantation was the most frequent event of interest, with negative peaks in the time series in 2016 and 2020, presumably due to the introduction of rechargeable pulse generators and to the COVID-19 pandemic, respectively.

The Association Between Bodily Functions and Cognitive/Emotional Factors in Patients With Chronic Pain Treated With Neuromodulation: A Systematic Review and Meta-Analyses.

OBJECTIVES: To date, pain relief in general continues to be the most prominent outcome measurement in daily routine care and clinical research. Nevertheless, the awareness of a shift toward more functional outcomes and/or emotional and cognitive outcomes has been raised. The interplay between bodily functions (such as pain intensity) and emotional or cognitive factors, however, has not yet been fully elucidated. The aim of this study was to systematically review the evidence for associations between bodily functions and cognitive and emotional factors in patients with chronic pain who are treated with neuromodulation. MATERIALS AND METHODS: Four data bases were consulted for this systematic literature review: PubMed, Web of Science, Scopus, and Embase. The Downs and Black Checklist (modified) was used to assess the risk of bias. The study protocol was prospectively registered at the International prospective register of systematic reviews (PROSPERO, CRD42021226803). If two or more studies reported correlation coefficients for a specific association, a meta-analysis based on correlation coefficients was performed for that specific association. RESULTS: The initial data base search identified a total of 1432 studies, of which 19 studies were eventually included in the systematic review. Evidence was found for two associations: 1) a positive correlation between pain intensity and anxiety (r = 0.42; 95% CI, 0.34 to 0.50) and 2) a positive correlation between pain intensity and depression (r = 0.32; 95% CI, 0.10 to 0.51). The association between pain intensity and catastrophizing was not statistically significant (r = 0.23; 95% CI, -0.36 to 0.69). CONCLUSIONS: On the basis of the associations between pain intensity and anxiety/depression, a biopsychosocial approach might be the most suitable in clinical practice to properly address all aspects of the International Classification of Functioning, Disability, and Health framework in patients who are treated with neuromodulation.

Gradation of Clinical Holistic Response as New Composite Outcome to Evaluate Success in Spinal Cord Stimulation Studies for Pain.

INTRODUCTION: The most prominent outcome measurement in the field of neuromodulation is pain relief. Nevertheless, the number of studies that rely on composite outcomes has increased. The aims of this study are twofold: (1) to evaluate which measures are important to include in a composite outcome and (2) to develop this new composite outcome to evaluate the degree of being a clinical holistic responder with a corresponding minimal clinical important difference (MCID). MATERIALS AND METHODS: Data from patients with persistent spinal pain syndrome type 2 treated with High-Dose Spinal Cord Stimulation (HD-SCS) were used. Pain intensity for low back and leg pain, disability, health-related quality of life, medication use, and patient satisfaction were measured at baseline and after 12 months of HD-SCS. Exploratory and Confirmatory Factor Analyses were used to evaluate which measures should be included in the composite outcome. Anchor-based and distribution-based methods were applied to determine the MCID of the newly developed outcome measurement. RESULTS: A three-factor model was the most appropriate for this data set, in which leg pain intensity, EQ5D VAS, and disability had the largest loading on these factors. A clinical holistic outcome was created with a total score ranging from 0 (=better [no pain, no disability, and perfect health status]) to 300 (=worse [maximal pain, maximal disability, and worst health status]). The MCID value based on an absolute change score from baseline up to 12 months of HD-SCS was 87.97. When calculating with percentage changes, a MCID value of 48.4% was revealed. CONCLUSIONS: This new composite outcome evaluating the degree of deviation from being a holistic responder is a step toward a meaningful, overall outcome assessment for patients who are treated with SCS. Further studies to evaluate the psychometric properties and the generalizability toward other patient populations still need to be performed.

Opinions of Health Care Providers About Neuromodulation for Pain: Results of an Online Survey at the 2nd Joint Congress of the International Neuromodulation Society European Chapters.

INTRODUCTION: Neuromodulation for pain has been successfully applied for decades, in that the goals and expectations that patients aim to achieve are clearly described. Nevertheless, the point of view of health care providers is less clear. Therefore, this study aimed to explore the goals, expectations, and definition of success for neuromodulation for pain according to health care providers. MATERIALS AND METHODS: An online survey was developed and spread at the 2nd Joint Congress of the International Neuromodulation Society (INS) European Chapters in September 2021 in Paris. Respondents were asked 1) to select the goals to treat patients with neuromodulation for pain, 2) to indicate factors that they expect to change according to neuromodulation for pain, and 3) to provide their definition of success of neuromodulation for pain. RESULTS: We approached 101 respondents, of whom 88 health care providers at least partly completed the survey. Increasing mobility/functionality (26.7%), decreasing pain intensity (24.5%), and decreasing medication use (16.6%) were the most frequently reported goals of neuromodulation. The same top three variables were selected as factors that health care providers expected to change. For the definition of success, quality of life of patients outranked other definitions. Other highly ranked definitions, in descending order, were obtaining pain relief, increasing functionality, and increasing patient satisfaction. DISCUSSION: Goals and expectations of health care providers are not completely in line with previously explored goals of patients that are related to pain relief and improving walking abilities. Health care providers seem to put a high emphasis on the quality of life of the patient when evaluating the success of neuromodulation, which is not completely aligned with the currently used reimbursement rules that are mainly focusing on pain relief instead of incorporating health-related quality of life. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05013840.

Cross-Country Differences in Pain Medication Before and After Spinal Cord Stimulation: A Pooled Analysis of Individual Patient Data From Two Prospective Studies in the United Kingdom and Belgium.

OBJECTIVES: Spinal cord stimulation (SCS) can reduce the need for opioids; however, the influence on the full spectrum of pain medication is less known. The aims of this study were to explore general prescription practices for patients scheduled for SCS, potential differences in prescriptions between Belgium and United Kingdom, and the influence of SCS on pain medication. MATERIALS AND METHODS: Individual patient data from the TRIAL-STIM study in the United Kingdom and DISCOVER in Belgium were pooled. Medication use was collected before SCS and three months after SCS from 180 chronic pain patients. The Medication Quantification Scale III (MQS) was used to calculate a total score for medication use, as well as subscores for several classes. Differences in prescription practices between United Kingdom and Belgium were evaluated with two-sided Wilcoxon tests. To evaluate differences in medication use after three months of SCS between United Kingdom and Belgium, Tweedie-generalized linear models were calculated. RESULTS: There was a statistically significant difference (-6.40 [95% CI from -3.40 to -9.10]) between the median total MQS score in United Kingdom and Belgium before SCS. Additionally, a significant difference was found for nonsteroidal anti-inflammatory drugs (NSAIDs) (-3.40 [95% CI -3.40 to -6.80]), neuropathic agents (-2.30 [95% CI -0.40 to -3.80]), and benzodiazepines (1.83e-05 [95% CI 2.64-05 to 7.45-05]) between United Kingdom and Belgium, before SCS. Tweedie-generalized models revealed a statistically significant interaction between country and time for MQS, neuropathic agents, and opioids. CONCLUSIONS: Our combined analysis revealed differences in prescription practice in patients scheduled for SCS implantation between Belgium and United Kingdom. NSAIDs and neuropathic mood agents are more frequently used in the United Kingdom, presumably due to easier access to repeat prescriptions and over the counter medications. After three months of SCS, a decrease in medication use is observed in both countries, with higher reductions in Belgium, presumably due to strict regulations concerning reimbursement criteria.

Spinal Cord Stimulation-Naïve Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population?

INTRODUCTION: Nowadays, the success of spinal cord stimulation (SCS) is evaluated separately in patients who have previous experiences with standard SCS and in SCS-naïve patients. Nevertheless, it is yet to be evaluated whether both patient groups are effectively distinct patient groups. Therefore, the aims of this study are twofold: 1) Are there clusters in the data to distinguish between both patient groups? 2) Can we discriminate both patient groups based on routinely collected clinical parameters? MATERIALS AND METHODS: Baseline data from the Discover study were used, in which 263 patients with persistent spinal pain syndrome type 2 were included (185 neurostimulation-naïve patients and 78 patients with previous SCS experience). Pain intensity scores for low back and leg pain, functional disability, medication use, and health-related quality of life utility scores were used in the analysis. Model-based clustering was performed on standardized data. Discriminant analysis was performed with linear and quadratic discriminant analysis, with leave-one-out cross-validation to evaluate model performance. RESULTS: Model-based clustering revealed two different clusters in the data. None of the clusters clearly separated SCS-naïve patients from patients with previous SCS experience. Linear discriminant analysis resulted in a leave-one-out cross-validation error rate of 30.0% to discriminate between both patient groups, based on routinely collected clinical parameters. CONCLUSIONS: Clustering analysis did not result in clusters that separate SCS-naïve patients from patients with previous SCS experience. This may suggest that both patient groups should not be considered as two different patient groups when comparing them on routine clinical parameters, with potentially profound implications for research and clinical settings. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the Discover study is NCT02787265.

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.

Virtual Reality for Decreasing Procedural Pain during Botulinum Toxin Injection Related to Spasticity Treatment in Adults: A Pilot Study.

BACKGROUND AND OBJECTIVES: Botulinum toxin injections are commonly used for the treatment of spasticity. However, injection procedures are associated with pain and procedural anxiety. While pharmacological approaches are commonly used to reduce these, innovative technology might be considered as a potential non-pharmacological alternative. Given this context, immersive virtual reality (VR) has shown effectiveness in the management of procedural pain. Our retrospective pilot study aimed to assess the potential added value of virtual reality in the management of pain and anxiety during intramuscular injections of botulinum toxin. MATERIALS AND METHODS: Seventeen adult patients receiving botulinum toxin injections were included. A numerical rating scale was used to assess pain and anxiety during the injection procedure. The patients reported the pain experienced during previous injections without VR before injection and the pain experienced in the current procedure with VR after the end of the procedure. The level of satisfaction of VR experience, whether or not they agreed to reuse VR for the subsequent toxin botulinum injection, and whether or not they would recommend VR to other patients were assessed. RESULTS: The use of virtual reality led to a decrease of 1.8 pain-related points compared to the procedure without technology. No significant improvement in the level of anxiety was reported. Patients were very satisfied with their VR experiences (7.9 out of 10), and many would agree to reuse VR in their next injection procedure (88%) and to recommend the use of VR in other patients (100%). CONCLUSION: VR was useful for managing procedural pain related to botulinum toxin injection in adults, with a high level of satisfaction reported by the patients. VR should be considered as a valuable alternative to pharmacological approaches to manage procedural pain during botulinum toxin injection in adults.

Health-related quality of life deviations from population norms in patients with lumbar radiculopathy: associations with pain, pain cognitions, and endogenous nociceptive modulation.

PURPOSE: The primary goal of this study was to compare the health-related quality of life (HRQoL) of people with lumbar radiculopathy to age- and sex-adjusted population norms. Additionally, it aimed to explore the associations between the HRQoL difference scores and measures related to pain cognitions, pain intensity, and endogenous nociceptive modulation. METHODS: Using answers from the Short Form 36-item Health Survey and UK population norms, SF-6D difference scores were calculated. A one-sample t test was used to assess the SF-6D difference scores. Univariate and multivariate regression analyses were used to assess the associations between SF-6D difference scores and pain intensity [Visual Analogue Scale (VAS) for back and leg pain], pain cognitions [Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia (TSK), Pain Vigilance and Awareness Questionnaire (PVAQ)], and correlates for endogenous nociceptive modulation using quantitative sensory testing. RESULTS: One hundred and twenty people with lumbar radiculopathy scheduled for surgery were included in this study. The mean SF-6D difference score of - 0.26 [SD = 0.09] was found to be significantly less than 0 [95%CI: - 0.27 to - 0.24]. Univariate analyses showed a significant influence from PCS, TSK, and PVAQ on the SF-6D difference scores. The final multivariate regression model included PCS and PVAQ, with only PCS maintaining a statistically significant regression coefficient [b = - 0.002; 95% CI: - 0.004 to - 0.001]. CONCLUSION: People diagnosed with lumbar radiculopathy report significantly lower HRQoL scores when compared with age- and sex-adjusted UK norm values. Even though all examined pain cognitions were found to have a significant association, pain catastrophizing showed the most significant relation to the SF-6D difference scores. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier No. NCT02630732. Date of registration: November 25, 2015.

Detoxification of Neuromodulation-Eligible Patients by a Standardized Protocol: A Retrospective Pilot Study.

OBJECTIVES: Patients eligible for spinal cord stimulation (SCS) generally experience excruciating pain, requiring more opioid consumption, which is usually an indication for SCS implantation. After final implantation, SCS has the ability to stabilize or decrease opioid usage in half of the patients. In this study, opioids were actively eliminated prior to implantation of any neuromodulation device with a standardized detoxification protocol. This pilot study aims to explore the feasibility, effectiveness, and safety of this opioid detoxification protocol prior to neuromodulation techniques. MATERIALS AND METHODS: In this retrospective pilot study, 70 patients who were taking opioids and who were eligible for neuromodulation techniques underwent the detoxification program. A combined in- and out-patient clinic protocol was applied, whereby clonidine was the main component of both parts of the program. A multidisciplinary team with pain physicians and psychologists was responsible for performing this detoxification program. Safety and feasibility were systematically recorded during the hospitalization. RESULTS: No serious safety issues were reported. At the start of the program, patients reported a mild sedative effect of clonidine. Additionally, most patients presented mild symptoms of opioid withdrawal, which were partially countered by the sedative effect of clonidine. Both patients and the medical staff found this protocol feasible in clinical practice. Concerning the effectiveness, a statistically significant decrease in median morphine milligram equivalents (MMEs) was found with an MME of 175 (Q1-Q3: 118.1-240) at baseline, and at the last available follow-up visit the MME was 0 (Q1-Q3: 0-16.88). CONCLUSIONS: This standardized detoxification program has proven its effectiveness, safety, and feasibility in this single-center experience pilot study in patients eligible for neuromodulation techniques.

The Link Between Spinal Cord Stimulation and the Parasympathetic Nervous System in Patients With Failed Back Surgery Syndrome.

OBJECTIVES: In patients with chronic pain, a relative lower parasympathetic activity is suggested based on heart rate variability measurements. It is hypothesized that spinal cord stimulation (SCS) is able to influence the autonomic nervous system. The aim of this study is to further explore the influence of SCS on the autonomic nervous system by evaluating whether SCS is able to influence skin conductance, blood volume pulse, heart rate, and respiration rate. MATERIALS AND METHODS: Twenty-eight patients with Failed Back Surgery Syndrome (FBSS), who are being treated with SCS, took part in this multicenter study. Skin conductance and cardiorespiratory parameters (blood volume pulse, heart rate, and respiration rate) were measured during on and off states of SCS. Paired statistics were performed on a 5-min recording segment for all parameters. RESULTS: SCS significantly decreased back and leg pain intensity scores in patients with FBSS. Skin conductance level and blood volume pulse were not altered between on and off states of SCS. Heart rate and respiration rate significantly decreased when SCS was activated. CONCLUSIONS: Parameters that are regulated by the sympathetic nervous system were not significantly different between SCS on and off states, leading to the hypothesis that SCS is capable of restoring the dysregulation of the autonomic nervous system by primarily increasing the activity of the parasympathetic system in patients with FBSS.

Acceptance and Commitment Therapy to Increase Resilience in Chronic Pain Patients: A Clinical Guideline.

Chronic pain remains a very difficult condition to manage for healthcare workers and patients. Different options are being considered and a biopsychosocial approach seems to have the most benefit, since chronic pain influences biological, psychological and social factors. A conservative approach with medication is the most common type of treatment in chronic pain patients; however, a lot of side effects are often induced. Therefore, a premium is set on novel nonpharmacological therapy options for chronic pain, such as psychological interventions. Previous research has demonstrated that resilience is a very important aspect in coping with chronic pain. A more recent type of cognitive-behavioural therapy is Acceptance and Commitment Therapy, in which psychological flexibility is intended to be the end result. In this manuscript, current evidence is used to explain why and how a comprehensive and multimodal treatment for patients with chronic pain can be applied in clinical practice. This multimodal treatment consists of a combination of pain neuroscience education and cognitive-behavioural therapy, more specifically Acceptance and Commitment Therapy. The aim is to provide a clinical guideline on how to contribute to greater flexibility and resilience in patients with chronic pain.