Trajectories of Disability and Low Back Pain Impact 2-year Follow-up of the Groningen Spine Cohort:2-year Follow-up of the Groningen Spine Cohort

STUDY DESIGN: Prospective cohort study OBJECTIVE.: To identify treatment response trajectories in patients with low back pain (LBP) during and after multidisciplinary care in a tertiary spine center, and to examine baseline patient characteristics that can distinguish trajectories. SUMMARY OF BACKGROUND DATA: Treatment response is often heterogeneous between patients with LBP. Knowledge on key characteristics that are associated with courses of disability could identify patients at risk for less favorable outcome. This knowledge will help improve shared decision making. METHODS: Adult patients with LBP completed questionnaires on disability (Pain Disability Index) and LBP impact (Impact Stratification of the National Institutes of Health minimal dataset) at baseline, 6, 12, 18, and 24 months follow-up. Latent class analyses were applied to identify trajectories of disability and LBP impact. Baseline socio-demographic and clinical patient characteristics were compared between trajectory subgroups. RESULTS: Follow-up was available for 996 patients on disability and 707 patients on LBP impact. Six trajectories were identified for both outcome measures. Three disability trajectories remained stable at distinct levels of severity (68% of patients) and three trajectories showed patterns of recovery (32%). For LBP impact there was one stable trajectory (17%), two slightly improving (59%), two recovering (15%), and one with a pattern of recovery and relapse (15%). Significant differences between trajectories were observed for almost all baseline patient characteristics. CONCLUSIONS: On average, patients show moderate improvements in disability and LBP impact two years after visiting a multidisciplinary tertiary spine center. However, latent class analyses revealed that most patients belong to subgroups experiencing stable levels of disability and LBP impact. Differences in baseline patient characteristics were mostly associated with baseline levels of functioning, instead of (un)favorable outcome during follow-up. LEVEL OF EVIDENCE: 2

What can we learn from long-term studies on chronic low back pain?:A scoping review

PURPOSE: A scoping review was conducted with the objective to identify and map the available evidence from long-term studies on chronic non-specific low back pain (LBP), to examine how these studies are conducted, and to address potential knowledge gaps. METHOD: We searched MEDLINE and EMBASE up to march 2021, not restricted by date or language. Experimental and observational study types were included. Inclusion criteria were: participants between 18 and 65 years old with non-specific sub-acute or chronic LBP, minimum average follow-up of > 2 years, and studies had to report at least one of the following outcome measures: disability, quality of life, work participation, or health care utilization. Methodological quality was assessed using the Effective Public Health Practice Project quality assessment. Data were extracted, tabulated, and reported thematically. RESULTS: Ninety studies met the inclusion criteria. Studies examined invasive treatments (72%), conservative (21%), or a comparison of both (7%). No natural cohorts were included. Methodological quality was weak (16% of studies), moderate (63%), or strong (21%) and generally improved after 2010. Disability (92%) and pain (86%) outcomes were most commonly reported, followed by work (25%), quality of life (15%), and health care utilization (4%). Most studies reported significant improvement at long-term follow-up (median 51 months, range 26 months-18 years). Only 10 (11%) studies took more than one measurement > 2 year after baseline. CONCLUSION: Patients with persistent non-specific LBP seem to experience improvement in pain, disability and quality of life years after seeking treatment. However, it remains unclear what factors might have influenced these improvements, and whether they are treatment-related. Studies varied greatly in design, patient population, and methods of data collection. There is still little insight into the long-term natural course of LBP. Additionally, few studies perform repeated measurements during long-term follow-up or report on patient-centered outcomes other than pain or disability

A guide for standardized interpretation of lumbar multifidus ultrasonography:an observational study

BACKGROUND: Inconsistent descriptions of Lumbar multifidus (LM) morphology were previously identified, especially in research applying ultrasonography (US), hampering its clinical applicability with regard to diagnosis and therapy. The aim of this study is to determine the LM-sonoanatomy by comparing high-resolution reconstructions from a 3-D digital spine compared to standard LM-ultrasonography. METHODS: An observational study was carried out. From three deeply frozen human tissue blocks of the lumbosacral spine, a large series of consecutive photographs at 78 μm interval were acquired and reformatted into 3-D blocks. This enabled the reconstruction of (semi-)oblique cross-sections that could match US-images obtained from a healthy volunteer. Transverse and oblique short-axis views were compared from the most caudal insertion of LM to L1. RESULTS: Based on the anatomical reconstructions, we could distinguish the LM from the adjacent erector spinae (ES) in the standard US imaging of the lower spine. At the lumbosacral junction, LM is the only dorsal muscle facing the surface. From L5 upwards, the ES progresses from lateral to medial. A clear distinction between deep and superficial LM could not be discerned. We were only able to identify five separate bands between every lumbar spinous processes and the dorsal part of the sacrum in the caudal anatomical cross-sections, but not in the standard US images. CONCLUSION: The detailed cross-sectional LM-sonoanatomy and reconstructions facilitate the interpretations of standard LM US-imaging, the position of the separate LM-bands, the details of deep interspinal muscles, and demarcation of the LM versus the ES. Guidelines for electrode positioning in EMG studies should be refined to establish reliable and verifiable findings. For clinical practice, this study can serve as a guide for a better characterisation of LM compared to ES and for a more reliable placement of US-probe in biofeedback

Reply to Jensen, O.K. On the Use of Quantitative Sensory Testing to Estimate Central Sensitization in Humans. Comment on "Schuttert et al. The Definition, Assessment, and Prevalence of (Human Assumed) Central Sensitisation in Patients with Chronic Low Back Pain: A Systematic Review. J. Clin. Med. 2021, 10, 5931":A Systematic Review. J. Clin. Med. 2021, 10, 5931"

We thank Dr. Jensen for his interest [...]

The C4EB study—Transvamix (10% THC / 5% CBD) to treat chronic pain in epidermolysis bullosa:A protocol for an explorative randomized, placebo controlled, and double blind intervention crossover study

Patients with the genetic blistering skin condition epidermolysis bullosa (EB) report severe pain as a consequence of skin and mucous membrane lesions including blisters, wounds, and scars. Adequate symptom alleviation is not often achieved using conventional pharmacologic interventions. Finding novel approaches to pain care in EB is imperative to improve the quality of life of patients living with EB. There are several anecdotal reports on the use of cannabinoid-based medicines (CBMs) by EB patients to reduce the burden of symptoms. However, controlled clinical investigations assessing these reported effects are lacking. As the pain quality “unpleasantness” delineates EB pain, we hypothesize the modulation of affective pain processing in the brain by way of intervention with CBMs comprising the cannabinoids Δ-9-tetrahydrocannabinol and cannabidiol—objectified by functional magnetic resonance imaging (fMRI). The C4EB study is an investigator-initiated, single-centre, randomized, double-blind, placebo-controlled and crossover trial. Adult patients with the diagnosis epidermolysis bullosa, reporting chronic pain will be eligible to participate. Following baseline measurements, participants will be randomized to receive the sublingually administered interventions placebo and Transvamix(®) in forward or reversed orders, each for two weeks and separated by a washout. The primary outcome is the difference in numeric rating scale pain scores between grouped interventions, using affective descriptors within the Short-form McGill Pain Questionnaire-2. Secondary outcomes include pain self-efficacy, concomitant analgesic medication-use and adverse events. Additionally, fMRI will be employed to assess brain connectivity related to neuroanatomic pain circuits at baseline, placebo and Transvamix(®) interventions. The study was approved by the ethical committee at the University Medical Center of Groningen in the Netherlands. Results will be submitted for publication in a peer-reviewed journal. Trial registration number: Netherlands Trial Register: NL9347 (Acronym: C4EB)

Identifying Epidermolysis Bullosa Patient Needs and Perceived Treatment Benefits:An Explorative Study Using the Patient Benefit Index

Epidermolysis bullosa (EB) is a genetic blistering skin condition for which no cure exists. Symptom alleviation and quality of life are therefore central to EB care. This study aimed to gain insight into EB patient needs and benefits from current clinical care. Two questionnaires were administered cross-sectionally to adult EB patients at the Dutch expertise centre for blistering diseases. Patient needs and benefits were analyzed using the patient benefit index survey (PBI-S). Ancillary data were compiled pertaining to self-reported EB severity, pain and pruritus, as well as current and previous treatments. In total, 104 participants were included (response rate 69.8%). Sixty-eight participants comprised the analyzed cohort (n = 36 omitted from analysis). The needs given the highest importance were to get better skin quickly (64.7%) and to be healed of all skin alterations (61.8%). A positive correlation between pain and EB severity and the importance of most needs was observed. Minimal clinically important differences within the PBI-S, relating to reported benefits from clinical care, were reported by 60.3% of the cohort. This study highlights a discrepancy between patient needs and feasible treatment outcomes. Utilizing the PBI-S in conjunction with well-established multidisciplinary care may catalyze the process of tailoring treatments to the needs of individual patients

Validity of the Central Sensitization Inventory to Address Human Assumed Central Sensitization:Newly Proposed Clinically Relevant Values and Associations

Central sensitization cannot be directly demonstrated in humans and thus a gold standard is missing. Therefore, we used human assumed central sensitization (HACS) when associated with humans. The central sensitization inventory (CSI) is a screening questionnaire for addressing symptoms that are associated with HACS. This cross-sectional study compared patients with chronic pain and at least one central sensitivity syndrome with healthy, pain-free controls via ROC analyses. Analyses were performed for all participants together and for each sex separately. Regression analyses were performed on patients with chronic pain with and without central sensitivity syndromes. Based on 1730 patients and 250 healthy controls, cutoff values for the CSI for the total group were established at 30 points: women: 33 points; men: 25 points. Univariate and multivariate regression analyses were used to identify possible predictors for the CSI score in 2890 patients with chronic pain. The CSI score is associated with all independent factors and has a low association with pain severity in women and a low association with pain severity, age, and body mass index in men. The newly established CSI cutoff values are lower than in previous studies and different per sex, which might be of clinical relevance in daily practice and importance in research.</p

Avoiding Catch-22:Validating the PainDETECT in a in a population of patients with chronic pain

BACKGROUND: Neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system and is a major therapeutic challenge. Several screening tools have been developed to help physicians detect patients with neuropathic pain. These have typically been validated in populations pre-stratified for neuropathic pain, leading to a so called "Catch-22 situation:" "a problematic situation for which the only solution is denied by a circumstance inherent in the problem or by a rule". The validity of screening tools needs to be proven in patients with pain who were not pre-stratified on basis of the target outcome: neuropathic pain or non-neuropathic pain. This study aims to assess the validity of the Dutch PainDETECT (PainDETECT-Dlv) in a large population of patients with chronic pain. METHODS: A cross-sectional multicentre design was used to assess PainDETECT-Dlv validity. Included where patients with low back pain radiating into the leg(s), patients with neck-shoulder-arm pain and patients with pain due to a suspected peripheral nerve damage. Patients' pain was classified as having a neuropathic pain component (yes/no) by two experienced physicians ("gold standard"). Physician opinion based on the Grading System was a secondary comparison. RESULTS: In total, 291 patients were included. Primary analysis was done on patients where both physicians agreed upon the pain classification (n = 228). Compared to the physician's classification, PainDETECT-Dlv had a sensitivity of 80% and specificity of 55%, versus the Grading System it achieved 74 and 46%. CONCLUSION: Despite its internal consistency and test-retest reliability the PainDETECT-Dlv is not an effective screening tool for a neuropathic pain component in a population of patients with chronic pain because of its moderate sensitivity and low specificity. Moreover, the indiscriminate use of the PainDETECT-Dlv as a surrogate for clinical assessment should be avoided in daily clinical practice as well as in (clinical-) research. Catch-22 situations in the validation of screening tools can be prevented by not pre-stratifying the patients on basis of the target outcome before inclusion in a validation study for screening instruments. TRIAL REGISTRATION: The protocol was registered prospectively in the Dutch National Trial Register: NTR 3030

Reducing work pressure and IT problems and facilitating IT integration and audit &amp; feedback help adherence to perioperative safety guidelines: a survey among 95 perioperative professionals

Background: To improve perioperative patient safety, guidelines for the preoperative, peroperative, andpostoperative phase were introduced in the Netherlands between 2010 and 2013. To help the implementation ofthese guidelines, we aimed to get a better understanding of the barriers and drivers of perioperative guidelineadherence and to explore what can be learned for future implementation projects in complex organizations.Methods: We developed a questionnaire survey based on the theoretical framework of Van Sluisveld et al. forclassifying barriers and facilitators. The questionnaire contained 57 statements derived from (a) an instrument formeasuring determinants of innovations by the Dutch Organization for Applied Scientific Research, (b) interviewswith quality and safety policy officers and perioperative professionals, and (c) a publication of Cabana et al. Thetarget group consisted of 232 perioperative professionals in nine hospitals. In addition to rating the statements on afive-point Likert scale (which were classified into the seven categories of the framework: factors relating to theintervention, society, implementation, organization, professional, patients, and social factors), respondents wereinvited to rank their three most important barriers in a separate, extra open-ended question.Results: Ninety-five professionals (41%) completed the questionnaire. Fifteen statements (26%) were considered tobe barriers, relating to social factors (N = 5), the organization (N = 4), the professional (N = 4), the patient (N = 1),and the intervention (N = 1). An integrated information system was considered an important facilitator (70.4%) aswell as audit and feedback (41.8%). The Barriers Top-3 question resulted in 75 different barriers in nearly allcategories. The most frequently reported barriers were as follows: time pressure (16% of the total number ofbarriers), emergency patients (8%), inefficient IT structure (4%), and workload (3%).Conclusions: We identified a wide range of barriers that are believed to hinder the use of the perioperative safetyguidelines, while an integrated information system and local data collection and feedback will also be necessary toengage perioperative teams. These barriers need to be locally prioritized and addressed by tailored implementationstrategies. These results may also be of relevance for guideline implementation in general in complex organizations.Trial registration: Dutch Trial Registry: NTR3568.Keywords: Guideline adherence, Implementation, Implementation barriers, Implementation facilitators, Patientsafety, Perioperative car