Should we Oppose or Combine Waveforms for Spinal Cord Stimulation in PSPS-T2 Patients? A Prospective Randomized Crossover Trial (MULTIWAVE Study).

Refractory persistent spinal pain syndrome after surgery (PSPS-T2) can be successfully addressed by spinal cord stimulation (SCS). While conventional stimulation generates paresthesia, recent systems enable the delivery of paresthesia-free stimulation. Studies have claimed non-inferiority/superiority of selected paresthesia-free stimulation compared with paresthesia-based stimulation, but the comparative efficacy between different waveforms still needs to be determined in a given patient. We designed a randomized controlled 3-month crossover trial to compare pain relief of paresthesia-based stimulation versus high frequency versus burst in 28 PSPS-T2 patients implanted with multiwave SCS systems. Our secondary objectives were to determine the efficacy of these 3 waveforms on pain surface, quality of life, functional capacity, psychological distress, and validated composite multidimensional clinical response index to provide holistic comparisons at 3-, 6-, 9-, and 15-month post-randomization. The preferred stimulation modality was documented during the follow-up periods. No difference between the waveforms was observed in this study (P = .08). SCS led to significant pain relief, quality of life improvement, improvement of multidimensional clinical response index, and of all other clinical outcomes at all follow-up visits. Forty-four percent of the patients chose to keep the paresthesia-based stimulation modality after the 15-month follow-up period. By giving the possibility to switch and/or to combine several waveforms, the overall rate of SCS responders further increased with 25%. In this study, high frequency or burst do not appear superior to paresthesia-based stimulation, wherefore paresthesia-based stimulation should still be considered as a valid option. However, combining paresthesia-based stimulation with paresthesia-free stimulation, through personalized multiwave therapy, might significantly improve SCS responses. PERSPECTIVE: This article assesses clinical SCS efficacy on pain relief, by comparing paresthesia-based stimulation and paresthesia-free stimulation (including high frequency and burst) modalities in patient presenting with PSPS-T2. Switching and/or combining waveforms contribute to increasing the global SCS responders rate.

Management of post-traumatic stress disorder symptoms by yoga: an overview.

BACKGROUND: Posttraumatic stress disorder (PTSD) can occur after trauma. While PTSD management strategies include first-line pharmacotherapy and psychotherapy, mind-body therapies, such as yoga, are applied in the PTSD population. This overview aimed to summarize the effectiveness of yoga interventions on PTSD symptoms in adults in a systematic review (SR) including randomized controlled trials (RCTs). METHOD: We searched for SR with or without meta-analysis of RCTs involving adults with PTSD diagnosis or trauma history. The search was conducted until April 2022, through six databases (Cochrane Database, MEDLINE (Pubmed), Scopus, Embase, CINHAL and PEDro). The primary outcome was the evolution of PTSD symptoms throughout the intervention. Secondary outcomes included follow-up, safety, adherence, and cost of the intervention. Two authors independently performed the selection, data extraction and risk of bias assessment with the AMSTAR 2 tool and overlap calculation. This overview is a qualitative summary of the results obtained in the selected studies. RESULTS: Eleven SRs were analyzed, of which 8 included meta-analyses. The overlap between studies was considered very high (corrected covered area of 21%). Fifty-nine RCTs involving 4434 participants were included. Yoga had a significant small-to-moderate effect-size on PTSD symptom decrease in 7 SRs and non-significant effects in 1 SR with meta-analysis. All SR without meta-analysis found beneficial effects of yoga on PTSD. Secondary outcomes were not sufficiently assessed to provide clear evidence. Results should be interpreted with caution as 1 SR was rated as at moderate risk of bias, 3 as low and 7 as critically low. CONCLUSIONS: While yoga therapy seems promising for decreasing PTSD symptoms, future research should standardize yoga therapy duration/frequency/type and consider long-term efficacy to better delineate yoga therapy efficacy in PTSD patients.

"Neuro-Fiber Mapping": An Original Concept of Spinal Cord Neural Network Spatial Targeting Using Live Electrostimulation Mapping to (Re-)Explore the Conus Medullaris Anatomy.

Spinal cord (SC) anatomy is often assimilated to a morphologically encapsulated neural entity, but its functional anatomy remains only partially understood. We hypothesized that it could be possible to re-explore SC neural networks by performing live electrostimulation mapping, based on "super-selective" spinal cord stimulation (SCS), originally designed as a therapeutical tool to address chronic refractory pain. As a starting point, we initiated a systematic SCS lead programming approach using live electrostimulation mapping on a chronic refractory perineal pain patient, previously implanted with multicolumn SCS at the level of the conus medullaris (T12-L1). It appeared possible to (re-)explore the classical anatomy of the conus medullaris using statistical correlations of paresthesia coverage mappings, resulting from 165 different electrical configurations tested. We highlighted that sacral dermatomes were not only located more medially but also deeper than lumbar dermatomes at the level of the conus medullaris, in contrast with classical anatomical descriptions of SC somatotopical organization. As we were finally able to find a morphofunctional description of "Philippe-Gombault's triangle" in 19th-century historical textbooks of neuroanatomy, remarkably matching these conclusions, the concept of "neuro-fiber mapping" was introduced.

Proportion of clinical holistic responders in patients with persistent spinal pain syndrome type II treated by subthreshold spinal cord stimulation compared to best medical treatment: a study protocol for a multicentric randomised controlled trial (TRADITION).

BACKGROUND: Integrating information on bodily functions, pain intensity and quality of life into one composite measure of a holistic responder has recently been proposed as a useful method to evaluate treatment efficacy of spinal cord stimulation (SCS) in patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2). Previous studies already demonstrated the efficacy of standard SCS over best medical treatment (BMT) and the superiority of new subthreshold (i.e. paresthesia free) SCS paradigms compared to standard SCS. Nevertheless, the efficacy of subthreshold SCS compared to BMT has not yet been investigated in patients with PSPS-T2, neither with unidimensional outcomes nor with a composite measure. The current objective is to examine whether subthreshold SCS, compared to BMT, provided to patients with PSPS-T2 results in a different proportion of clinical holistic responders (as composite measure) at 6 months. METHODS: A two-arm multicentre randomised controlled trial will be conducted whereby 114 patients will be randomised (1:1) to (a) BMT or (b) paresthesia-free SCS. After a follow-up period of 6 months (primary time endpoint), patients receive the opportunity to cross over towards the other treatment group. The primary outcome is the proportion of clinical holistic responders at 6 months (i.e. a composite measure of pain intensity, medication, disability, health-related quality of life and patient satisfaction). The secondary outcomes are work status, self-management, anxiety, depression and healthcare expenditure. DISCUSSION: Within the TRADITION project, we propose to shift the focus from a unidimensional outcome measure towards a composite measure as primary outcome measure to evaluate the efficacy of currently used subthreshold SCS paradigms. The lack of methodologically rigorous trials exploring the clinical efficacy and socio-economic consequences of subthreshold SCS paradigms is pressing, especially in light of the growing burden of PSPS-T2 on the society. TRIAL REGISTRATION: ClinicalTrials.gov NCT05169047. Registered on December 23, 2021.

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.

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.

Feasibility, acceptability and effects of dance therapy in stroke patients: A systematic review.

INTRODUCTION: Stroke is the leading cause of non-traumatic disability in adults, with balance and gait disturbances representing the main limitations of body functions. Dance therapy (DT) has shown positive effects in older adults and in patients with neurological pathologies. This systematic review aims to examine the feasibility, acceptability and effects of DT in stroke rehabilitation, specifically on functional gains of gait and balance. METHODS: A systematic search was carried out for articles published in the MEDLINE, PEDro, Web of Science, Scopus and CINHAL in February 2021 and updated in April 2021. RESULTS: Eight studies were included (2 clinical cases, 5 case series and 1 randomized controlled trial), 7 of them in patients with chronic stroke and only 1 in subacute stroke phase. The most widely used dance modality was tango and ballet, with sessions ranging from 30 to 110 min. DT seems to show positive effects on post-stroke body functions and activities such as gait and balance. Reported dropout rates are inconsistent, no adverse effects were reported, and participant satisfaction was high. CONCLUSION: Given the heterogeneity and uneven quality of the included studies, strong conclusions cannot be put forward on the effectiveness of DT in post-stroke body function and activities. Nevertheless, DT seems to be safe and acceptable therapy for patients, and no adverse effects have been reported. More studies with a high level of evidence and feasibility are needed to determine the patient profile, the characteristics of the intervention, the participation rate and the role of the rehabilitation professional most likely to generate optimal benefit.

A 6-Month Home-Based Functional Electrical Stimulation Program for Foot Drop in a Post-Stroke Patient: Considerations on a Time Course Analysis of Walking Performance.

Foot drop is a common disability in post-stroke patients and represents a challenge for the clinician. To date, ankle foot orthosis (AFO) combined with conventional rehabilitation is the gold standard of rehabilitation management. AFO has a palliative mechanical action without actively restoring the associated neural function. Functional electrical stimulation (FES), consisting of stimulation of the peroneal nerve pathway, represents an alternative approach. By providing an FES device (Bioness L-300, BIONESS, Valencia, CA, USA) for 6 months to a post-stroke 22-year-old woman with a foot drop, our goal was to quantify its potential benefit on walking capacity. The gait parameters and the temporal evolution of the speed were collected with a specific connected sole device (Feet Me®) during the 10-m walking, the time up and go, and the 6-minute walking tests with AFO, FES, or without any device (NO). As a result, the walking speed changes on 10-m were clinically significant with an increase from the baseline to 6 months in AFO (+0.14 m.s-1), FES (+0.36 m.s-1) and NO (+0.32 m.s-1) conditions. In addition, the speed decreased at about 4-min in the 6-minute walking test in NO and AFO conditions, while the speed increased in the FES conditions at baseline and after 1, 3, and 6 months. In addition to the walking performance improvement, monitoring the gait speed in an endurance test after an ecological rehabilitation training program helps to examine the walking performance in post-stroke patients and to propose a specific rehabilitation program.

Virtual Reality Applications in Chronic Pain Management: Systematic Review and Meta-analysis.

BACKGROUND: Virtual reality (VR) is a computer technology that immerses a user in a completely different reality. The application of VR in acute pain settings is well established. However, in chronic pain, the applications and outcome parameters influenced by VR are less clear. OBJECTIVE: This review aimed to systematically identify all outcome parameters that are reported in relation to VR in patients with chronic pain. METHODS: A total of 4 electronic databases (PubMed, Scopus, Web of Science, and Embase) were searched for relevant studies. Multilevel random-effect meta-analyses were performed, whereby the standardized mean difference was chosen as the effect size to denote the difference between measurements before and after a VR intervention. RESULTS: The initial database search identified 1430 studies, of which 41 (2.87%) were eventually included in the systematic review. Evidence has been found for the effects of VR on pain, functioning, mobility, functional capacity, psychological outcomes, quality of life, neuropsychological outcomes, and physical sensations. The overall effect size (a total of 194 effect sizes from 25 studies) based on a three level meta-analysis was estimated at 1.22 (95% CI 0.55-1.89; z=3.56; P<.001), in favor of improvements after a VR intervention. When categorizing effect sizes, the overall effect sizes were reported as follows: 1.60 (95% CI 0.83-2.36; z=4.09; P<.001) for the effect of VR on pain (n=31), 1.40 (95% CI 0.13-2.67; z=2.17; P=.03) for functioning (n=60), 0.49 (95% CI -0.71 to 1.68; z=0.80; P=.42) for mobility (n=24), and 0.34 (95% CI -1.52 to 2.20; z=0.36; P=.72) for functional capacity (n=21). CONCLUSIONS: This systematic review revealed a broad range of outcome variables influenced by an intervention of VR technology, with statistically significant pain relief and improvements in functioning. These findings indicate that VR not only has applications in acute pain management but also in chronic pain settings, whereby VR might be able to become a promising first-line intervention as complementary therapy for patients with chronic pain. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42021227016; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=227016.

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.

Hypnosis to manage musculoskeletal and neuropathic chronic pain: A systematic review and meta-analysis.

This systematic review and meta-analysis aims to identify and quantify the current available evidence of hypnosis efficacy to manage pain in patients with chronic musculoskeletal and neuropathic pain. Randomized Control Trials (RCTs) with hypnosis and/or self-hypnosis treatment used to manage musculoskeletal and/or neuropathic chronic pain in adults and assessing pain intensity were included. Reviews, meta-analyses, non-randomized clinical trials, case reports and meeting abstracts were excluded. Five databases, up until May 13th 2021, were used to search for RCTs using hypnosis to manage chronic musculoskeletal and/or neuropathic pain. The protocol is registered on PROSPERO register (CRD42020180298) and no specific funding was received for this review. The risk of bias asessement was conducted according to the revised Cochrane risk of bias tool for randomized control trials (RoB 2.0). Nine eligible RCTs including a total of 530 participants were considered. The main analyses showed a moderate decrease in pain intensity (Hedge's g: -0.42; p = 0.025 after intervention, Hedge's g: -0.37; p = 0.027 after short-term follow-up) and pain interference (Hedge's g: -0.39; p = 0.029) following hypnosis compared to control interventions. A significant moderate to large effect size of hypnosis compared to controls was found for at 8 sessions or more (Hedge's g: -0.555; p = 0.034), compared to a small and not statistically significant effect for fewer than 8 sessions (Hedge's g: -0.299; p = 0.19). These findings suggest that a hypnosis treatment lasting a minimum of 8 sessions could offer an effective complementary approach to manage chronic musculoskeletal and neuropathic pain. Future research is needed to delineate the relevance of hypnosis in practice and its most efficient prescription.

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.

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.

Long-Term Efficacy of Occipital Nerve Stimulation for Medically Intractable Cluster Headache.

BACKGROUND: Occipital nerve stimulation (ONS) has been proposed to treat refractory chronic cluster headache (rCCH) but its efficacy has only been showed in small short-term series. OBJECTIVE: To evaluate ONS long-term efficacy in rCCH. METHODS: We studied 105 patients with rCCH, treated by ONS within a multicenter ONS prospective registry. Efficacy was evaluated by frequency, intensity of pain attacks, quality of life (QoL) EuroQol 5 dimensions (EQ5D), functional (Headache Impact Test-6, Migraine Disability Assessment) and emotional (Hospital Anxiety Depression Scale [HAD]) impacts, and medication consumption. RESULTS: At last follow-up (mean 43.8 mo), attack frequency was reduced >50% in 69% of the patients. Mean weekly attack frequency decreased from 22.5 at baseline to 9.9 (P < .001) after ONS. Preventive and abortive medications were significantly decreased. Functional impact, anxiety, and QoL significantly improved after ONS. In excellent responders (59% of the patients), attack frequency decreased by 80% and QoL (EQ5D visual analog scale) dramatically improved from 37.8/100 to 73.2/100. When comparing baseline and 1-yr and last follow-up outcomes, efficacy was sustained over time. In multivariable analysis, low preoperative HAD-depression score was correlated to a higher risk of ONS failure. During the follow-up, 67 patients experienced at least one complication, 29 requiring an additional surgery: infection (6%), lead migration (12%) or fracture (4.5%), hardware dysfunction (8.2%), and local pain (20%). CONCLUSION: Our results showed that long-term efficacy of ONS in CCH was maintained over time. In responders, ONS induced a major reduction of functional and emotional headache-related impacts and a dramatic improvement of QoL. These results obtained in real-life conditions support its use and dissemination in rCCH patients.

High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study.

ABSTRACT: The use of high-dose spinal cord stimulation (HD-SCS) has increased drastically during the past few years, with positive results. However, there remains a deficit of real-world data of the effectiveness of HD-SCS. Therefore, the primary aim was to evaluate the effectiveness of HD-SCS in patients with failed back surgery syndrome (FBSS). The second aim was to develop a prediction model for a holistic responder. One hundred ninety-four patients were recruited to a multicenter real-world registry. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 3, and 12 months of HD-SCS implant. Outcome measures were the mean pain intensity over time, sleep quality, disability, health-related quality of life, and medication use. Besides the effectiveness, logistic regression and decision tree analysis were performed to define a holistic responder (pain intensity reduction, medication reduction, Oswestry disability index reduction, and EQ5D improvement) after 12 months of HD-SCS. Of 185 FBSS patients who underwent a baseline visit, 75.13% had a successful HD trial. At 12 months, 92 patients were still receiving HD-SCS. Both low back and leg pain significantly decreased at 12 months. All outcome measures revealed a significant time-dependent effect from baseline to 12 months. Holistic responders could be predicted with a sensitivity and specificity of 90%. Clinically significant and sustained pain relief over a period of 12 months was achieved with HD-SCS in patients with FBSS. In addition, HD-SCS also achieved an improvement in sleep quality, functionality, and a decrease in pain medication.

Peripheral Nerve Field Stimulation for Chronic Back Pain: Therapy Outcome Predictive Factors.

OBJECTIVE: To identify variables that influence pain reduction following peripheral nerve field stimulation (PNFS) in order to identify a potential responder profile. METHODS: Exploratory univariate and multivariate (random forest) analyses were performed separately on 2 randomized controlled trials and a registry; all included patients with chronic back pain, mainly failed back surgery syndrome. An international expert panel judged the clinical relevance of variables to identify responders by consensus. RESULTS: Variables identified that may help predict PNFS success in patients with back pain include patient and pain characteristics (age, time since onset of pain and spinal surgery, pain medication history, position and size of pain area, pain severity, mixed nociceptive/neuropathic pain, health-related quality of life, depression, functional disability, and leg pain status), implant procedure variables (the number and position of leads, paresthesia coverage, and amount of pain relief during the trial), and programming (number of programs, cathodes, and anodes; pulse rate; pulse width; and percentage of device usage). CONCLUSIONS: While these analyses are exploratory and restricted to a limited sample size, they suggest variables that may play a role in predicting a therapeutic response. These results, however, are informative only and should be cautiously interpreted. Future research to validate the variables in a clinical study is needed.

Hypnosis Program Effectiveness in a 12-week Home Care Intervention To Manage Chronic Pain in Elderly Women: A Pilot Trial.

PURPOSE: As the prevalence of pain increases with age, taking too much medication can lead to negative side effects in elderly patients. While evidence in the literature has shown that clinical hypnosis is effective in an adult population, there are few studies in an aging population and efficacy has never been established in a home care setting. The goal of this study was to determine the effects of a hypnosis program delivered during home care interventions in elderly women during a 12-week period. METHODS: This pilot trial took place from April 2016 to October 2017 at Limoges, France. Fifteen elderly women with chronic pain participated (81 (65-87) years old). All participants presented chronic pain for more than 6 months (inclusion criteria: average pain score >4/10). Participants took part in three 15-min hypnosis sessions separated by four to six weeks. Each hypnosis session was personalized and carried out with induction, pain perception alteration, and post-hypnotic suggestions. Pain perception and pain interference were evaluated with the Brief Pain Inventory questionnaire, and compared between before and after the 12-week hypnosis program. FINDINGS: Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01). IMPLICATIONS: Taken together, these findings show that a hypnosis intervention is feasible and effective to manage pain in an elderly population.

Peripheral Nerve Stimulation of Brachial Plexus Nerve Roots and Supra-Scapular Nerve for Chronic Refractory Neuropathic Pain of the Upper Limb.

OBJECTIVES: We report the outcome of a consecutive series of 26 patients suffering from chronic medically-refractory neuropathic pain of the upper limb (including 16 patients with complex regional pain syndrome), topographically limited, treated by brachial plexus (BP) nerve roots or supra-scapular nerve (SSN) peripheral nerve stimulation (PNS). MATERIALS AND METHODS: The technique consisted in ultrasound-guided percutaneous implantation of a cylindrical lead (Pisces-Quad, Medtronic) close to the SSN or the cervical nerve roots within the BP, depending on the pain topography. All the patients underwent a positive trial stimulation before lead connection to a subcutaneous stimulator. Chronic bipolar stimulation mean parameters were: frequency 55.5 Hertz, voltage 1.17 Volts. The voltage was set below the threshold inducing muscle contractions or paresthesias. RESULTS: Two patients were lost immediately after surgery. At last follow-up (mean 27.5 months), the 20 patients still using the stimulation experienced a mean pain relief of 67.1%. Seventeen patients were improved ≥50%, including 12 improved ≥70%. In 11 patients with a follow-up >2 years, the mean pain relief was 68%. At last follow-up, respectively, six out of the nine (67%) patients treated by SSN stimulation and 10 out of 17 patients (59%) treated by BP stimulation were improved ≥50%. At last follow-up, 12 out of 20 patients still using the stimulation were very satisfied, six were satisfied, and two were poorly satisfied. Complications were: stimulation intolerance due to shock-like sensations (three cases), superficial infection (1), lead fractures (2), and migration (1). CONCLUSION: In this pilot study, SSN or BP roots PNS provided a relatively safe, durable and effective option to control upper limb neuropathic pain.

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

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