Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study.

BACKGROUND: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. METHODS AND DESIGN: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. DISCUSSION: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023.

Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial.

Importance: Insomnia is highly prevalent in patients with nonspecific chronic spinal pain (nCSP). Given the close interaction between insomnia and pain, targeting sleep problems during therapy could improve treatment outcomes. Objective: To evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBTi) integrated in best-evidence pain management (BEPM) vs BEPM only in patients with nCSP and insomnia. Design, Setting, and Participants: A multicenter randomized clinical trial with 1-year follow-up was conducted between April 10, 2018, and April 30, 2022. Data and statistical analysis were performed between May 1, 2022, and April 24, 2023. Patients with nCSP and insomnia were evaluated using self-report and at-home polysomnography, to exclude underlying sleep pathologic factors. Participants were treated at the University Hospital Brussels or University Hospital Ghent, Belgium. Intention-to-treat analysis was performed. Interventions: Participants were randomized to either CBTi-BEPM or BEPM only. Both groups received 18 treatment sessions over 14 weeks. The CBTi-BEPM treatment included 6 CBTi sessions and 12 BEPM sessions. The BEPM treatment included pain neuroscience education (3 sessions) and exercise therapy (9 sessions in the CBTi-BEPM group, 15 sessions in the BEPM-only group). Main Outcomes and Measures: The primary outcome was change in mean pain intensity (assessed with Brief Pain Inventory [BPI]) at 12 months after the intervention. Exploratory secondary outcomes included several pain- and sleep-related outcomes. Blinded outcome assessment took place at baseline, posttreatment, and at 3-, 6-, and 12-month follow-up. Results: A total of 123 patients (mean [SD] age, 40.2 [11.18] years; 84 women [68.3%]) were included in the trial. In 99 participants (80.5%) with 12-month BPI data, the mean pain intensity at 12 months decreased by 1.976 points (reduction of 40%) in the CBTi-BEPM group and 1.006 points (reduction of 24%) points in the BEPM-only group. At 12 months, there was no significant difference in pain intensity change between groups (mean group difference, 0.970 points; 95% CI, -0.051 to 1.992; Cohen d, 2.665). Treatment with CBTi-BEPM resulted in a response for BPI average pain with a number needed to treat (NNT) of 4 observed during 12 months. On a preliminary basis, CBTi-BEPM was, consistently over time and analyses, more effective than BEPM only for improving insomnia severity (Cohen d, 4.319-8.961; NNT for response ranging from 2 to 4, and NNT for remission ranging from 5 to 12), sleep quality (Cohen d, 3.654-6.066), beliefs about sleep (Cohen d, 5.324-6.657), depressive symptoms (Cohen d, 2.935-3.361), and physical fatigue (Cohen d, 2.818-3.770). No serious adverse effects were reported. Conclusions and Relevance: In this randomized clinical trial, adding CBTi to BEPM did not further improve pain intensity reduction for patients with nCSP and comorbid insomnia more than BEPM alone. Yet, as CBTi-BEPM led to significant and clinically important changes in insomnia severity and sleep quality, CBTi integrated in BEPM should be considered in the treatment of patients with nCSP and comorbid insomnia. Further research can investigate the patient characteristics that moderate the response to CBTi-BEPM in terms of pain-related outcomes, as understanding of these moderators may be of utmost clinical importance. Trial Registration: Clinical Trials.gov Identifier: NCT03482856.

Large-scale real-world data on a multidisciplinary approach to spinal cord stimulation for persistent spinal pain syndromes: first evaluation of the Neuro-Pain® nationwide screening and follow-up interactive register.

Introduction: Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data. Methods: In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed. Results: Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term. Discussion: Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process.

The Role of Anxiety and Depression in Shaping the Sleep-Pain Connection in Patients with Nonspecific Chronic Spinal Pain and Comorbid Insomnia: A Cross-Sectional Analysis.

(1) Background: This exploratory study aims to explore the relationship between nonspecific chronic spinal pain (nCSP) and insomnia symptoms, by examining the interconnections, strengths, and directional dependence of the symptoms. In addition, we aim to identify the key symptoms of the nCSP-insomnia relationship and shed light on the bidirectional nature of this relationship. (2) Methods: This study is a secondary analysis of the baseline data (cross-sectional) from a randomized controlled trial, which examined the added value of Cognitive Behavioral Therapy for Insomnia (CBT-I) combined with cognition-targeted exercise therapy, conducted in collaboration with the Universiteit Gent and Vrije Universiteit Brussel (Belgium). One hundred and twenty-three nCSP patients with comorbid insomnia were recruited through the participating hospitals, advertisements, announcements in local newspapers, pharmacies, publications from support groups, and primary care. To explore the interconnections and directionality between symptoms and the strengths of the relationships, we estimated a regularized Gaussian graphical model and a directed acyclic graph. (3) Results: We found only one direct, but weak, link between sleep and pain, namely, between average pain and difficulties maintaining sleep. (4) Conclusions: Despite the lack of strong direct links between sleep and pain, pain and sleep seem to be indirectly linked via anxiety and depression symptoms, acting as presumable mediators in the network of nCSP and comorbid insomnia. Furthermore, feeling slowed down and fatigue emerged as terminal nodes, implying their role as consequences of the network.

The Mediating Role of Pain Cognitions and Pain Sensitivity in the Treatment Effect of Perioperative Pain Neuroscience Education in People Undergoing Surgery for Lumbar Radiculopathy.

Though perioperative pain neuroscience education (PPNE) positively influences patients' surgical outcomes, little is known about the mechanisms behind this treatment's success. Therefore, this study aims to evaluate the potential mediating role of pain cognitions and pain sensitivity in the treatment effect of PPNE on postoperative quality of life in people undergoing surgery for lumbar radiculopathy. This secondary analysis uses data from 120 participants of a randomized controlled trial who were randomized to receive either PPNE or perioperative biomedical education before undergoing surgery for lumbar radiculopathy. Quality of life was assessed 1-year postsurgery using the short form 36-item health survey (SF36) physical and mental component scores. Potential mediators included pain cognitions (ie, kinesiophobia, pain catastrophizing, and hypervigilance) and pain sensitivity (ie, endogenous nociceptive modulation), assessed 6 weeks postsurgery. Mediation models were constructed using structural equation modeling, and 95% confidence intervals (CIs) were calculated using 10,000 bootstrap samples. Analyses show a significant total effect for PPNE (estimate = .464, 95% CI [.105, .825]) and a significant indirect effect via pain catastrophizing on the SF36 physical component (estimate = .124, 95% CI [.001, .293]). No mediating effect was found through the remaining pain cognitions or pain sensitivity measures. Also, no potential mediators were identified for the treatment effect of PPNE on the SF36 mental component. Our findings suggest that pain catastrophizing mediates the treatment effect of PPNE on physical health-related quality of life in people undergoing surgery for lumbar radiculopathy. PERSPECTIVE: This secondary analysis identified pain catastrophizing as a mediator for PPNE in people undergoing surgery for lumbar radiculopathy. More so, its findings indicate that this educational intervention can enhance the postoperative physical health-related quality of life of these patients by addressing their catastrophizing thoughts. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02630732).

Discussing sexual health with patients eligible for spine surgery: An online survey in spine surgeon and pain physicians.

Introduction: Spinal pain syndromes have a severe impact on the patient's sex life, contributing to a decrease in sexual function and sexual satisfaction. Despite the importance of sexual health on mental and physical wellbeing, sexual health is rarely discussed during consultations. Research question: The aim of this study is to explore to what extent influencing factors can alter the discussion about sexual health during consultations. More specifically, we will evaluate the influence of healthcare profession, sex of the patient and the surgical approach that is proposed. Material and methods: An online survey was sent to neurosurgeons, pain physicians and orthopedists in Belgium and The Netherlands in April 2019. Participants were asked about; counseling routine, knowledge, and opinion on sexual health. Answers were scored on a 5-point Likert scale. Independence between the response levels and type of surgery as well as profession were tested. Results: In total, 350 respondents were approached of whom 57 completed the survey. The majority of respondents (61.4%) indicated that they rarely or never discussed sexual disturbances. Profession and type of surgery had an influence on discussing erectile dysfunction, retrograde ejaculation, and alterations in orgasms. Thirty-five percent of healthcare providers considered it the patient's responsibility to bring up the subject of sexual health. Discussion and conclusion: Sexual health is rarely addressed by healthcare providers during spinal care. Profession as well as type of surgery seems to play a role on whether sexual health is discussed during consultations.

Gut dysbiosis in patients with chronic pain: a systematic review and meta-analysis.

Introduction: Recent evidence supports the contribution of gut microbiota dysbiosis to the pathophysiology of rheumatic diseases, neuropathic pain, and neurodegenerative disorders. The bidirectional gut-brain communication network and the occurrence of chronic pain both involve contributions of the autonomic nervous system and the hypothalamic pituitary adrenal axis. Nevertheless, the current understanding of the association between gut microbiota and chronic pain is still not clear. Therefore, the aim of this study is to systematically evaluate the existing knowledge about gut microbiota alterations in chronic pain conditions. Methods: Four databases were consulted for this systematic literature review: PubMed, Web of Science, Scopus, and Embase. The Newcastle-Ottawa Scale was used to assess the risk of bias. The study protocol was prospectively registered at the International prospective register of systematic reviews (PROSPERO, CRD42023430115). Alpha-diversity, ß-diversity, and relative abundance at different taxonomic levels were summarized qualitatively, and quantitatively if possible. Results: The initial database search identified a total of 3544 unique studies, of which 21 studies were eventually included in the systematic review and 11 in the meta-analysis. Decreases in alpha-diversity were revealed in chronic pain patients compared to controls for several metrics: observed species (SMD= -0.201, 95% CI from -0.04 to -0.36, p=0.01), Shannon index (SMD= -0.27, 95% CI from -0.11 to -0.43, p<0.001), and faith phylogenetic diversity (SMD -0.35, 95% CI from -0.08 to -0.61, p=0.01). Inconsistent results were revealed for beta-diversity. A decrease in the relative abundance of the Lachnospiraceae family, genus Faecalibacterium and Roseburia, and species of Faecalibacterium prausnitzii and Odoribacter splanchnicus, as well as an increase in Eggerthella spp., was revealed in chronic pain patients compared to controls. Discussion: Indications for gut microbiota dysbiosis were revealed in chronic pain patients, with non-specific disease alterations of microbes. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42023430115.

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.

Biopsychosocial rehabilitation in the working population with chronic low back pain: a concept analysis.

OBJECTIVE: To identify the essential attributes of biopsychosocial rehabilitation for chronic low back pain in the working population. DESIGN: A concept analysis was conducted according to the 8-step method of Walker and Avant. This framework provides a clear concept and theoretical and operational definitions. METHODS: Five databases were searched, followed by a systematic screening. Subsequently, attributes, illustrative cases, antecedents, consequences and empirical referents were formulated. RESULTS: Of the 3793 studies identified, 42 unique references were included. Eleven attributes were identified: therapeutic exercise, psychological support, education, personalization, self-management, participation, follow-up, practice standard, goal-setting, social support, and dietary advice. Subsequently, illustrative cases were described. Antecedents, such as motivation, preparedness and a multidisciplinary team, were found, together with consequences such as decreased pain, less sick-leave and increased function and work status. Finally, examples of empirical referents were given. CONCLUSION: This study identified the attributes that are necessary to develop biopsychosocial rehabilitation intervention programmes for chronic low back pain. The defined concept of biopsychosocial rehabilitation for chronic low back pain may serve as a solid base to further develop and apply interventions. Future research should focus on the objectification of biopsychosocial rehabilitation and conceptualization regarding how personalization is done.

Influence of Preoperative Pain, Cognitions, and Quantitative Sensory Testing Measures on the Effects of Perioperative Pain Neuroscience Education for People Receiving Surgery for Lumbar Radiculopathy: Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To explore whether preoperative pain intensity, pain cognitions, and quantitative sensory measures influence the established effectiveness of perioperative pain neuroscience education (PPNE) on health-related quality of life at 1 year after surgery for lumbar radiculopathy. DESIGN: Secondary analysis of a triple-blinded randomized controlled trial. METHODS: Participants (n = 90) were Dutch-speaking adults (18-65 years) who were scheduled for surgery for lumbar radiculopathy in 3 Belgian hospitals. They were randomized (1:1) to receive PPNE (n = 41) or perioperative biomedical education (n = 49). Linear mixed models were built for health-related quality of life (ie, SF-6D utility values, Physical and Mental Component of the 36-item Short Form Health Survey) using the following independent variables: therapy, time, and preoperative scores for back and leg pain intensity, pain catastrophizing, kinesiophobia, hypervigilance, and quantitative sensory measures. RESULTS: The impact of PPNE on SF-6D utility values over time was influenced by kinesiophobia (F = 3.30, P = .02) and leg pain intensity (F = 3.48, P = .02). Regardless of the intervention, back pain intensity negatively influenced SF-6D values over time (F = 3.99, P = .009). The Physical Component scores were negatively impacted by back pain intensity (F = 9.08, P = .003) and were influenced over time by leg pain intensity (F = 2.87, P = .04). The Mental Component scores were negatively impacted by back pain intensity (F = 6.64, P = .01) and pain catastrophizing (F = 5.42, P = .02), as well as hypervigilance (F = 3.16, P = .03) and leg pain intensity (F = 3.12, P = .03) over time. CONCLUSION: PPNE may be more effective than perioperative biomedical education in improving postoperative health utility values in patients who reported higher kinesiophobia and leg pain intensity before surgery for lumbar radiculopathy. J Orthop Sports Phys Ther 2024;54(4):1-10. Epub 8 January 2024. doi:10.2519/jospt.2024.12051.

Do Patients with Chronic Spinal Pain and Comorbid Insomnia Have More Features of Central Sensitization? A Case-Control Study.

BACKGROUND: Chronic spinal pain (CSP) is a major public health problem worldwide, frequently related to sleep problems. Central sensitization (CS) may worsen the clinical picture of CSP patients with insomnia. The aim of this study was to compare self-reported and objectively measured clinical outcomes between insomniac CSP patients with comorbid insomnia with and without symptoms of CS. METHODS: A case-control study on baseline self-reported sleep, functioning, and psychological distress through online questionnaires. Objective sleep and physical activity parameters and pressure pain thresholds (PPTs) were assessed through polysomnography, actigraphy, and digital algometry, respectively. Independent sample t-test and Mann-Whitney U tests were used to examine possible differences in the outcome measures between the groups. RESULTS: Data from 123 participants were included and revealed no statistically significant group for objective sleep and physical activity parameters. The CS group, however, presented with worse self-reported sleep (quality sleep, insomnia severity, and dysfunctional beliefs about sleep), increased mental and physical fatigue, and higher psychological distress (anxiety and depressive symptoms), and reported lower PPTs. CONCLUSIONS: symptoms of CS may influence perceived sleep and affect functional health and well-being perception but do not seem to affect objective sleep and physical activity.

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.