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.

Mixture of longitudinal factor analyzers and their application to the assessment of chronic pain.

Multivariate longitudinal data are used in a variety of research areas not only because they allow to analyze time trajectories of multiple indicators, but also to determine how these trajectories are influenced by other covariates. In this article, we propose a mixture of longitudinal factor analyzers. This model could be used to extract latent factors representing multiple longitudinal noisy indicators in heterogeneous longitudinal data and to study the impact of one or several covariates on these latent factors. One of the advantages of this model is that it allows for measurement non-invariance, which arises in practice when the factor structure varies between groups of individuals due to cultural or physiological differences. This is achieved by estimating different factor models for different latent classes. The proposed model could also be used to extract latent classes with different latent factor trajectories over time. Other advantages of the model include its ability to take into account heteroscedasticity of errors in the factor analysis model by estimating different error variances for different latent classes. We first define the mixture of longitudinal factor analyzers and its parameters. Then, we propose an EM algorithm to estimate these parameters. We propose a Bayesian information criterion to identify both the number of components in the mixture and the number of latent factors. We then discuss the comparability of the latent factors obtained between subjects in different latent groups. Finally, we apply the model to simulated and real data of patients with chronic postoperative pain.

International Recommendations to Manage Poststroke Equinovarus Foot Deformity Validated by a Panel of Experts Using Delphi.

OBJECTIVE: To establish international recommendations for the management of spastic equinovarus foot deformity. DESIGN: Delphi method. SETTING: International study. PARTICIPANTS: A total of 24 international experts (N=24) in neuro-orthopedic deformities, from different specialties (Physical and Rehabilitation Medicine physicians, neurologists, geriatricians, orthopedic surgeons, neurosurgeons, plastic surgeons). INTERVENTIONS: Experts answered 3 rounds of questions related to important aspects of diagnosis, assessment, and treatment of spastic equinovarus foot deformity. MAIN OUTCOME MEASURES: A consensus was established when at least 80% of experts agreed on a statement RESULTS: A total of 52 items reached consensus. Experts recommend assessing effect of the deformity on functional activities before treatment. Before treatment, it is crucial to differentiate spastic muscle overactivity from soft tissue contractures, identify which muscles are involved in the deformity, and evaluate the activity of antagonist muscles. Motor nerve blocks, 2-dimensional video analysis, and radiologic examinations are often required to complement a clinical examination. The treatment of equinovarus foot depends on the correctability of the deformity and the patient's ability to stand or walk. The preoperative assessment should include an interdisciplinary consultation that must finalize a formal agreement between physicians and the patient, which will define personalized attainable goals before surgery. CONCLUSION: The establishment of guidelines on managing equinovarus foot will help physicians and surgeons, specialists, and nonspecialists to diagnoses and assess the deformity and direct patients to a network of experts to optimize patient functional recovery and improve their autonomy.

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.

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.

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.

Is Spinal Cord Stimulation Still Effective After One or More Surgical Revisions?

OBJECTIVES: Spinal cord stimulation (SCS) is burdened with surgical complications that may require one or several surgical revision(s), challenging its risk/benefit ratio and cost-effectiveness. Our objective was to evaluate its outcome and efficacy after one or more SCS surgical revisions. MATERIALS AND METHODS: We identified and retrospectively analyzed 116 patients treated by tonic paresthesia-based SCS who experienced one or more complication(s) requiring at least one surgical revision. Data collected included initial indication, revision indication, number of revisions, and lead design (paddle or percutaneous). Outcome after SCS revision was evaluated by pain intensity decrease (comparing baseline and postrevision Numerical Rating Scale [NRS] scores) and percentage of patients reporting pain relief ≥50%. Outcome was analyzed according to the number of surgical revisions and the revision indications. RESULTS: Most of the patients (61%) underwent only one revision (mean delay after implantation 44 months). The most frequent causes of revisions were hardware dysfunction (32%), lead migration (23%), and infection (18%). Revision(s) repaired the SCS issue in 87% of the cases. One year after the first revision, 82% of the patients reported pain relief ≥50%, and the mean NRS decrease was 4.0 compared with baseline (p < 0.001). Benefit of SCS revision tended to decrease with the number of revisions but did not differ across revision indications. No serious surgical complications related to the revision occurred, except for three hematomas occurring after repeated revisions. CONCLUSIONS: Our data suggest that surgical revision of SCS system is safe and led to significant pain relief in most of the cases, provided that the initial indication was good and that the previous stimulation was effective. However, success of SCS revision decreases with the number of revisions.

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.

Long-Term Efficacy of a Home-Care Hypnosis Program in Elderly Persons Suffering From Chronic Pain: A 12-Month Follow-Up.

BACKGROUND: Pain is a major public health concern in the aging population. However, medication brings about negative effects that compel healthcare professionals to seek alternative management techniques to alleviate pain. Hypnosis has been recognized as an effective technique to manage pain, but its long-term efficacy has yet to be examined in older adults. AIMS: The aim was to assess the effectiveness, over a 12-month period, of home-care hypnosis in elderly participants suffering from chronic pain. DESIGN: Real-life retrospective one-arm study with a 12-month follow-up. SETTINGS: Elderly Persons Suffering From Chronic Pain enrolled in a clinical health care program that offered home medical follow-up. PARTICIPANTS/SUBJECTS: Fourteen elderly women (mean age 81 years) with chronic pain participated in the home-care hypnosis program. All participants presented chronic pain (≥6 months) with average pain score >4/10. METHODS: Participants took part in seven 15-minute hypnosis sessions within 12 months. The Brief Pain Inventory questionnaire was used to evaluate pain perception and pain interference at baseline and at 3-, 6-, and 12-month follow-up period. RESULTS: Hypnosis home-care program significantly decreased pain perception and pain interference compared to baseline after 3 months (-29% and -40%, p < .001), and remained lower at 6 (-31% and -54%, p < .001) and 12 (-31% and -47%, p < .001) months. CONCLUSIONS: Seven sessions of 15 minutes allocated throughout a 12-month period produced clinically significant decreases in pain perception and pain interference. Hypnosis could be considered as an optimal additional way for health practitioners to manage chronic pain in an elderly population with long-term efficacy. This study offers a new long-term option to improve chronic pain management at home in elderly populations through a low-cost nonpharmacological intervention.

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.

Glossary of Neurostimulation Terminology: A Collaborative Neuromodulation Foundation, Institute of Neuromodulation, and International Neuromodulation Society Project.

OBJECTIVE: Consistent terminology is necessary to facilitate communication, but limited efforts have addressed this need in the neurostimulation community. We set out to provide a useful and updated glossary for our colleagues and prospective patients. MATERIALS AND METHODS: This collaborative effort of the Neuromodulation Foundation (NF), the Institute of Neuromodulation (IoN), and the International Neuromodulation Society (INS) expands a glossary first published in 2007 for spinal cord stimulation. Peripheral nerve, dorsal root ganglion, deep brain, and motor cortex stimulation have been added to our scope. Volunteers from the collaborating entities used a nominal group process, consensus development panels, and the Delphi technique to reach consensus on inclusion and definition of terms. We created a glossary suitable for print and for expansion on the websites of the collaborating entities, which will offer the possibility of explaining definitions for a general audience. We excluded proprietary and brand names but included terms that have attracted proprietary interest without becoming brands or trademarks. We made an effort to be inclusive while also being concise and economical with space. RESULTS: We identified and defined 91 terms for this print edition and created an accompanying list of acronyms. As appropriate, we provided figures to illustrate the definitions. CONCLUSIONS: Although we refer to the glossary presented herein as the print edition, it can of course be viewed and searched electronically. NF, IoN, and INS will continue to collaborate on expanded web editions that can include hyperlinks for internal and external navigation. We believe this glossary will benefit our growing field by facilitating communication and mitigating inappropriate use of neurostimulation terms.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for Surgical Technique for Spinal Cord Stimulation.

INTRODUCTION: The field of neurostimulation for the treatment of chronic pain is a rapidly developing area of medicine. Although neurostimulation therapies have advanced significantly as a result of technologic improvements, surgical planning, device placement, and postoperative care are of equal importance to optimize outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for these often-overlooked areas of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based on 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 the last NACC publication in 2017 to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on evidence strength and consensus when evidence was scant. RESULTS: This NACC project provides guidance on preoperative assessment, intraoperative techniques, and postoperative management in the form of consensus points with supportive evidence. These results are based on grade of evidence, strength of consensus, and expert opinion. CONCLUSIONS: The NACC has given guidance for a surgical plan that encompasses the patient journey from the planning stage through the surgical experience and postoperative care. The overall recommendations are designed to improve efficacy and the safety of patients undergoing these neuromodulation procedures and are intended to apply throughout the international community.

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.

The Added Value of Point-Light Display Observation in Total Knee Arthroplasty Rehabilitation Program: A Prospective Randomized Controlled Pilot Study.

Background and Objectives: The present study aimed to assess the potential benefit of the observation of rehabilitation-related point-light display in addition to a conventional 3-week rehabilitation program, the objective being to improve functional capacity in patients having undergone total knee arthroplasty. Materials and Methods: Patients randomized in the control group had conventional rehabilitation treatment with two sessions per day 5 days a week of physical therapy (90 min), whereas patients in the experimental group had a program of conventional rehabilitation combined with a point-light display observation two times per day (5 min) and 3 days a week. Results: The patients of both groups had improved their performances by the end of the program, and the pre- and post-test improvement were superior for the experimental group over the control group concerning the total WOMAC score (p = 0.04), the functional WOMAC score (p = 0.03), and correct recognition of point-light displays (p = 0.003). Conclusions: These findings provide new insight favoring systematic point-light display observation to improve functional recovery in patients with total knee arthroplasty.

The Added Value of Intraoperative Hypnosis during Spinal Cord Stimulation Lead Implantation under Awake Anesthesia in Patients Presenting with Refractory Chronic Pain.

To improve pain relief for refractory pain condition, spinal cord stimulation (SCS) needs to target the dedicated neuronal fibers within the dorsal columns. Intraoperative feedback from the patient can optimize lead placement but requires "awake surgery", allowing interaction between patient and surgeon. This can produce negative effects like anxiety and stress. To better manage these aspects, we propose to combine intraoperative hypnosis with awake anesthesia. Seventy-four patients (35 females, 22-80 years) presenting with chronic refractory pain, were offered intraoperative hypnosis during awake SCS lead implantation. Interactive conversational hypnosis was used as well as interactive touch, which was enhanced during painful moments during the lead intraoperative programming. All patients participated actively during the intraoperative testing which helped to optimize the lead positioning. They kept an extremely positive memory of the surgery and of the hypnotic experience, despite some painful moments. Pain could be reduced in these patients by using interactions and touch, which works on Gate Control modulation. Positive memory was reinforced by congratulations to create self-confidence and to induce positive expectations, which could reinforce the Diffuse Noxious Inhibitory Controls at the spinal level. Cooperation was improved because the patient was actively participating and thus, much more alert when feedback was required. Combining intraoperative hypnosis with awake anesthesia appears helpful for SCS lead implantation. It enhances patient cooperation, allows optimization of lead positioning, and leads to better pain control, positive and resourceful memory.

Persistent Spinal Pain Syndrome: A Proposal for Failed Back Surgery Syndrome and ICD-11.

OBJECTIVE: For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS. METHODS: This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established. RESULTS: 14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option-Persistent spinal pain syndrome-was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification. CONCLUSIONS: This project is important to those in the fields of pain management, spine surgery, and neuromodulation, as well as patients labeled with FBSS. Through a shift in perspective, it could facilitate the application of the new ICD-11 classification and allow clearer discussion among medical professionals, industry, funding organizations, academia, and the legal profession.

Vertebral balloon kyphoplasty versus vertebral body stenting in non-osteoporotic vertebral compression fractures at the thoracolumbar junction: a comparative radiological study and finite element analysis (BONEXP study).

OBJECTIVE: To compare radiologically balloon kyphoplasty (BKP) and vertebral compression fracture (VCF) expansion and corroborate with a finite element (FE) analysis. The principle of BKP is to stabilize VCF by restoring vertebral body anatomy using bone expansion and cement filling. More recently, vertebral body stenting (VBS) has been developed to reduce the loss of vertebral height observed after balloon deflation. METHODS: A retrospective, monocentric and continuous study of 60 non-osteoporotic fractures of the thoracolumbar junction treated by vertebral bone expansion was carried out over three years. The main endpoint was radiological correction of vertebral kyphosis (VK) at 3 months. The other studied parameters were vertebral height, index of Farcy, index of Beck, cement leakages and their location. A FE model was developed to analyze effects linked to the stent during cement injection, specifically throughout the risk of cement leakage evaluation. RESULTS: After three months, average reduction of VK was 4.73° ± 4.8° after BKP, and 4.63° ± 2.7° after VBS. There was no difference between the two techniques, but cement leakage was significantly greater with BKP (41.7%) than with VBS (4.2%). FE analysis showed substantial changes of the cement flow orientation in the presence of a stent. CONCLUSION: BKP and VBS offer comparable expansion with no added value of VBS in non-osteoporotic VCF reduction. VBS technique appears to prevent cement leakage due to its mesh architecture hindering the leaking process. In counterpart, such balloon expansion is likely to require higher pressure to deploy the stent. This could be an important parameter to take into account in young patients with high bone density.

Occipital Nerve Stimulation for Refractory Chronic Cluster Headache: A Cost-Effectiveness Study.

INTRODUCTION: Occipital nerve stimulation (ONS) is proposed to treat refractory chronic cluster headache (rCCH), but its cost-effectiveness has not been evaluated, limiting its diffusion and reimbursement. MATERIALS AND METHODS: We performed a before-and-after economic study, from data collected prospectively in a nation-wide registry. We compared the cost-effectiveness of ONS associated with conventional treatment (intervention and postintervention period) to conventional treatment alone (preintervention period) in the same patients. The analysis was conducted on 76 rCCH patients from the French healthcare perspective at three months, then one year by extrapolation. Because of the impact of the disease on patient activity, indirect cost, such as sick leave and disability leave, was assessed second. RESULTS: The average total cost for three months was €7602 higher for the ONS strategy compared to conventional strategy with a gain of 0.07 quality-adjusted life-years (QALY), the incremental cost-effectiveness ratio (ICER) was then €109,676/QALY gained. The average extrapolated total cost for one year was €1344 lower for the ONS strategy (p = 0.5444) with a gain of 0.28 QALY (p < 0.0001), the ICER was then €-4846/QALY gained. The scatter plot of the probabilistic bootstrapping had 80% of the replications in the bottom right-hand quadrant, indicating that the ONS strategy is dominant. The average indirect cost for three months was €377 lower for the ONS strategy (p = 0.1261). DISCUSSION: This ONS cost-effectiveness study highlighted the limitations of a short-time horizon in an economic study that may lead the healthcare authorities to reject an innovative strategy, which is actually cost-effective. One-year extrapolation was the proposed solution to obtain results on which healthcare authorities can base their decisions. CONCLUSION: Considering the burden of rCCH and the efficacy and safety of ONS, the demonstration that ONS is dominant should help its diffusion, validation, and reimbursement by health authorities in this severely disabled population.

How Should we Use Multicolumn Spinal Cord Stimulation to Optimize Back Pain Spatial Neural Targeting? A Prospective, Multicenter, Randomized, Double-Blind, Controlled Trial (ESTIMET Study).

BACKGROUND: Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP). OBJECTIVE: To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead. MATERIALS AND METHODS: Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up. RESULTS: At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001). CONCLUSION: The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.

Self-Reiki, Consideration of a Potential Option for Managing Chronic Pain during Pandemic COVID-19 Period.

While the world faces an unprecedented situation with the pandemic, other chronic diseases such as chronic pain continue to run their course. The social distancing and restrictive displacement imposed by the pandemic situation represents a new barrier to access to pain management and tends to reinforce chronification process. Given this context, complementary and alternative medicine (CAM) might offer new opportunities to manage CP, notably with a hand-touch method, such as self-Reiki therapy. Although Reiki administered by a practitioner has shown promising results to reduce pain and psychological distress, and to improve quality of life, self-Reiki practice needs evidence-based medicine to be disseminated. Overall, self-Reiki could bring positive results in addition to, and without interfering with, conventional medicine approaches in patients experienced chronic pain.