A new screening tool for early recognition of ATTRv polyneuropathy in clinical practice: AmyloScan.

Hereditary transthyretin (ATTRv) amyloidosis is a progressive multisystem disorder, mainly characterized by cardiac dysfunction and polyneuropathy. Due to its rarity and heterogeneous presentation, diagnosis is often delayed, which has a direct impact on the initiation of treatment and, therefore, span and quality of life. To facilitate early disease recognition, we aimed to develop and validate a new screening tool for early identification of ATTRv amyloidosis with polyneuropathy (AmyloScan).

Real-world data and evidence in pain research: an IMMPACT comprehensive review and best practice recommendations.

Real-world data (RWD) can be defined as routinely collected clinical or administrative data that might be used for research purposes and to generate real-world evidence (RWE). Computerized search and data mining methods, large electronic databases, and the development of novel computational and statistical methods allow for improved access to and analysis of RWD. Although RWD afford the opportunity to generate RWE with potentially improved efficiency and generalizability over prospective clinical studies, it is important to understand and apply best practices when analysing RWD, particularly when the goal is to generate RWE of diagnostic, prognostic, or treatment effectiveness.

The effects of lacosamide, pregabalin, and tapentadol on peripheral nerve excitability: A randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects.

Background: Chronic pain is a leading cause of disability globally, with limited treatment options and frequent adverse effects. The IMI-PainCare-BioPain project aimed to enhance analgesic drug development by standardizing biomarkers. This study, IMI2-PainCare-BioPain-RCT1, evaluated the effects of lacosamide, pregabalin, and tapentadol on peripheral nerve excitability in healthy subjects through a randomized, double-blind, placebo-controlled crossover trial.

Small Fiber Morphology and Function in Inclusion Body Myositis-A Multimodal Assessment Including Confocal Corneal Microscopy.

Introduction: The extent of peripheral nerve involvement in inclusion body myositis (IBM) remains a topic of ongoing scientific discussion. In this study, we aimed to explore the involvement of small nerve fibers in IBM using a range of diagnostic methods, including, for the first time, corneal confocal microscopy (CCM).

Methods: Nineteen clinic-pathologically or clinically defined IBM patients underwent comprehensive clinical and electrophysiological examinations.

Assessment of Mechanical Detection Thresholds in Healthy Participants and Patients With Neuropathy: A Comparison of OptiHair2 and Aesthesiometer II.

Background: Mechanical detection thresholds (MDTs) are used to assess somatosensory function but can only be evaluated considering the individual sex, age and tested body region. The German Research Network on Neuropathic Pain (DFNS) provides reference values for OptiHair2, a sensitive and expensive glass filament, while nylon filaments such as the Aesthesiometer II are more durable and affordable. In this study, we compare both devices regarding their use for MDT assessment in a variety of participants, thus intending to achieve a higher range for MDT.

A multimodal intervention of manual therapy, exercise, and psychological management for painful diabetic neuropathy: intervention development and feasibility trial protocol.

Background: Therapeutic options for people experiencing neuropathic pain from diabetic peripheral neuropathy are limited, and impact can be severe. Physical and psychological interventions remain under-explored but may offer promise, especially in multimodal combination programs.

Objectives And Methods: To address this gap, an intervention was developed according to the Medical Research Council's framework for complex interventions, including research expert and stakeholder input.

Predicting placebo analgesia responses in clinical trials: where to look next? A meta-analysis of individual patient data.

Estimating the magnitude of placebo responses across pharmacological and nonpharmacological trials is important for understanding their influence on trial outcomes. Yet, the extent to which more intense placebo interventions like sham acupuncture yield larger analgesic responses than placebo pills, and the factors predicting these responses, remain unclear. This meta-analysis investigated the magnitude and predictors of placebo analgesia responses in pharmacological vs acupuncture trials.

Pharmacotherapy and non-invasive neuromodulation for neuropathic pain: a systematic review and meta-analysis.

Background: There remains a substantial unmet need for effective and safe treatments for neuropathic pain. The Neuropathic Pain Special Interest Group aimed to update treatment recommendations, published in 2015, on the basis of new evidence from randomised controlled trials, emerging neuromodulation techniques, and advances in evidence synthesis.

Methods: For this systematic review and meta-analysis, we searched Embase, PubMed, the International Clinical Trials Registry, and ClinicalTrials.

Exploring the value of a well-established conditioned pain modulation paradigm in women: a Translational Research in Pelvic Pain (TRiPP) study.

Background: Conditioned pain modulation (CPM) is considered a human proxy for descending inhibitory pain pathways. However, there is wide variation in the CPM response described in the literature and ongoing debate about its utility.

Methods: Here we explored CPM in women with ( = 59) and without ( = 26) chronic pelvic pain (CPP), aiming to determine the magnitude of effect and factors influencing variability in the CPM response.

A core outcome set of measurement instruments for assessing effectiveness and efficacy of perioperative pain management: results of the international IMI-PainCare PROMPT Delphi consensus process.

Background: Effective perioperative pain management is crucial to prevent patient suffering, delayed recovery, chronic postsurgical pain, and long-term opioid use. However, the heterogeneous use of outcomes in studies complicates evidence synthesis and might not accurately reflect the experiences of individual patients. We initiated a consensus process to establish a core outcome set (COS) of patient-reported outcome measures (PROMs) in postoperative pain, building upon the earlier consensus on a COS of domains.

Review of Challenges in Performing Real-World Evidence Studies for Nonprescription Products.

In recent years, regulatory authorities have signaled a willingness to consider real-world evidence (RWE) data to support applications for new claims and indications for pharmaceuticals. Historically, RWE studies have been the domain of prescription drugs, driven by the fact that clinical data on patients are routinely captured in medical records, claims databases, registries, etc. However, RWE reports of nonprescription drugs and supplements are relatively sparse due to methodological gaps in this area.

Quantitative Sensory Testing - From bench to bedside.

The methodology of Quantitative Sensory Testing (QST) comprises standardized testing procedures, which provide information of the integrity of the somatosensory nervous system. Over the years, different protocols have been established, which utilize similar but distinct testing procedures. They pursue the same overall objective to identify loss or gain of function of the respective sensory parameter to better understand the degree of abnormal nervous function and thereby improve patient care in the long-term.

Navigating the light and shadow of scientific publishing faced with machine learning and generative AI.

Background: The public release of ChatGPT in November 2022 sparked a boom and public interest in generative artificial intelligence (AI) that has led to journals and journal families hastily releasing generative AI policies, ranging from asking authors for acknowledgement or declaration to the outright banning of use.

Results: Here, we briefly discuss the basics of machine learning, generative AI, and how it will affect scientific publishing. We focus especially on potential risks and benefits to the scientific community as a whole and journals specifically.

The impact of patients' pre-treatment expectations on immunosuppressive treatment outcomes in myasthenia gravis: A pilot correlational study.

Introduction/aims: The impact of treatment expectations on active treatment outcomes has not been specifically investigated in neuromuscular disorders. We thus explored in myasthenia gravis (MG) the contribution of patients' pre-treatment expectations combined with an immunosuppressant drug on treatment outcomes.

Methods: This pilot correlational study involved 17 patients with generalized MG, scheduled to start immunosuppressant azathioprine.

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement.

Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required.

Pain after combat injury in male UK military personnel deployed to Afghanistan.

Background: Chronic pain after injury poses a serious health burden. As a result of advances in medical technology, ever more military personnel survive severe combat injuries, but long-term pain outcomes are unknown. We aimed to assess rates of pain in a representative sample of UK military personnel with and without combat injuries.

Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process.

Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain mechanisms and treatments. Existing pain-related COS often focus on specific conditions, which can hamper data harmonization across various pain states.