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Objectives: To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs.Study Design: A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists.Results: We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants).Conclusion: Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure. [ABSTRACT FROM AUTHOR]

Background: Tension-type headache (TTH) is the most prevalent primary headache disorder. Neck pain is commonly associated with primary headaches and the trigemino-cervical complex (TCC) refers to the convergence of trigeminal and cervical afferents onto neurons of the brainstem, thus conceptualizes the emergence of headache in relation to neck pain. However, no objective biomarkers exist for the myofascial involvement in primary headaches. This study aimed to investigate the involvement of the trapezius muscles in primary headache disorders by quantitative magnetic resonance imaging (MRI), and to explore associations between muscle T2 values and headache frequency and neck pain., Methods: This cohort study prospectively enrolled fifty participants (41 females, age range 20-31 years): 16 subjects with TTH only (TTH-), 12 with mixed-type TTH plus migraine (TTH+), and 22 healthy controls (HC). The participants completed fat-suppressed T2-prepared three-dimensional turbo spin-echo MRI, a headache diary (over 30 days prior to MRI), manual palpation (two weeks before MRI), and evaluation of neck pain (on the day of MRI). The bilateral trapezius muscles were manually segmented, followed by muscle T2 extraction. Associations between muscle T2 and the presence of neck pain as well as the number of days with headache (considering the 30 days prior to imaging using the headache calendar) were analyzed using regression models (adjusting for age, sex, and body mass index)., Results: The TTH+ group demonstrated the highest muscle T2 values (right side: 31.4 ± 1.2 ms, left side: 31.4 ± 0.8 ms) as compared to the TTH- group or HC group (p < 0.001). Muscle T2 was significantly associated with the number of headache days (β-coefficient: 2.04, p = 0.04) and the presence of neck pain (odds ratio: 2.26, p = 0.04). With muscle T2 as the predictor, the area under the curve for differentiating between HC and the TTH+ group was 0.82., Conclusions: Increased T2 of trapezius muscles may represent an objective imaging biomarker for myofascial involvement in primary headache disorders, which could help to improve patient phenotyping and therapy evaluation. Pathophysiologically, the increased muscle T2 values could be interpreted as a surrogate of neurogenic inflammation and peripheral sensitization within myofascial tissues., (© 2023. The Author(s).)

Background: Repetitive neuromuscular magnetic stimulation (rNMS) of the trapezius muscles showed beneficial effects in preventing episodic migraine. However, clinical characteristics that predict a favorable response to rNMS are unknown. The objective of this analysis is to identify such predictors., Methods: Thirty participants with a diagnosis of episodic migraine (mean age: 24.8 ± 4.0 years, 29 females), who were prospectively enrolled in two non-sham-controlled studies evaluating the effects of rNMS were analyzed. In these studies, the interventional stimulation of the bilateral trapezius muscles was applied in six sessions and distributed over two consecutive weeks. Baseline and follow-up assessments included the continuous documentation of a headache calendar over 30 days before and after the stimulation period, the Migraine Disability Assessment Score (MIDAS) questionnaire (before stimulation and 90 days after stimulation), and measurements of pain pressure thresholds (PPTs) above the trapezius muscles by algometry (before and after each stimulation session). Participants were classified as responders based on a ≥25% reduction in the variable of interest (headache frequency, headache intensity, days with analgesic intake, MIDAS score, left-sided PPTs, right-sided PPTs). Post-hoc univariate and multivariate binary logistic regression analyses were performed., Results: Lower headache frequency ( P = 0.016) and intensity at baseline ( P = 0.015) and a migraine diagnosis without a concurrent tension-type headache component ( P = 0.011) were significantly related to a ≥25% reduction in headache frequency. Higher headache frequency ( P = 0.052) and intensity at baseline ( P = 0.014) were significantly associated with a ≥25% reduction in monthly days with analgesic intake. Lower right-sided PPTs at baseline were significantly related to a ≥25% increase in right-sided PPTs ( P = 0.015) and left-sided PPTs ( P =0.030). Performance of rNMS with higher stimulation intensities was significantly associated with a ≥25% reduction in headache intensity ( P = 0.046)., Conclusions: Clinical headache characteristics at baseline, the level of muscular hyperalgesia, and stimulation intensity may inform about how well an individual patient responds to rNMS. These factors may allow an early identification of patients that would most likely benefit from rNMS., Competing Interests: The Division of Pediatric Neurology and Developmental Medicine, Dr. von Hauner Children's Hospital, LMU Hospital, Munich Germany is provided by an emFieldPro magnetic stimulator by Zimmer MedizinSysteme GmbH (Neu-Ulm, Germany). NS and SK received honoraria from Nexstim Plc (Helsinki, Finland). SK received honoraria from Brainlab AG (Munich, Germany), Spineart (Frankfurt, Germany), Ulrich Medical (Ulm, Germany), Zeiss Meditec (Jena, Germany), and Medtronic (Dublin, Ireland). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Börner, Renner, Trepte-Freisleder, Urban, Schandelmaier, Lang, Lechner, Koenig, Klose, Albers, Krieg, Baum, Heinen, Landgraf, Sollmann and Bonfert.)

The objective of this study was to assess the burden of disease and prevalence of lifestyle factors for adolescents and young adults with frequent episodic migraine. We conducted a secondary comparative analysis of data collected during two previous studies. Inclusion criteria for this analysis were age 15-35 years, 15 to 44 migraine episodes within 12 weeks, and completeness of Migraine Disability Assessment and lifestyle questionnaire data. Datasets of 37 adults (median age [interquartile range]: 25 [6]) and 27 adolescents (median age [interquartile range]: 15 [1]) were analyzed. 81% ( n = 30) of adults reported severe disability (16% [ n = 3] of adolescents; p < 0.001). Headache frequency (24 vs. 17 days; p = 0.005) and prevalence of regular analgesic use (60% [ n = 22] vs. 18% [ n = 5]; p = 0.002) were significantly higher in adults. In adults, sleep duration on weekdays was significantly lower (8.5 vs. 10 h; p < 0.001). Any consumption of caffeine tended to be higher in adolescents and alcohol consumption tended to be higher in adults ( p > 0.05). This study underlines the importance of educating adolescents and young adults with migraine about lifestyle habits that are likely to interfere with the condition.

Background: Neck pain is frequent in patients with migraine. Likewise, evidence for inflammatory processes in the trapezius muscles is accumulating. However, non-invasive and objectively assessable correlates are missing in vivo ., Methods: Twenty-one subjects with episodic migraine (mean age: 24.6 ± 3.1 years, 18 females) and 22 controls (mean age: 23.0 ± 2.2 years, 17 females) without any history of headache prospectively underwent physical examination and quantitative magnetic resonance imaging of the trapezius muscles. A T2-prepared turbo spin-echo sequence was acquired for manual segmentation of the trapezius muscles and extraction of mean T2 values., Results: There were no statistically significant differences regarding age, sex, body mass index, or number of myofascial trigger points (mTrPs) between groups. All patients with migraine presented with mTrPs in the trapezius muscles. T2 of the entire trapezius muscles was significantly higher in the migraine group when compared to controls (31.1 ± 0.8 ms vs. 30.1 ± 1.1 ms; p  = 0.002)., Conclusions: Elevated T2 values of the trapezius muscles may indicate subtle inflammatory processes within musculature among patients with migraine because T2 increase is likely to stem from edematous changes. Future work may validate this finding in larger cohorts, but muscle T2 might have potential to develop into a viable in vivo biomarker for muscular affection in migraine.

Although migraine is a relevant health issue in children and adolescents, clinical care and research are still underrepresented and underfunded in this field. Quality of life can be significantly reduced when living with frequent episodes of pain. Due to the high level of vulnerability of the developing brain during adolescence, the risk of chronification and persistence into adulthood is high. In this narrative review, we describe the corner stones of a patient-centered, multimodular treatment regimen. Further, an update on the pathophysiology of migraine is given considering the concept of a periodically oscillating functional state of the brain in migraine patients ("migraine is a brain state"). Besides central mechanisms, muscular structures with the symptoms of muscular pain, tenderness, or myofascial trigger points play an important role. Against this background, the currently available nonpharmacological and innovative neuromodulating approaches are presented focusing on the method of repetitive peripheral magnetic stimulation.

Objectives: There is substantial variation in the classification and management of scapula fractures. The first purpose of this study was to analyze the interobserver reliability of the OTA/AO classification and the New International Classification for Scapula Fractures. The second purpose was to assess the proportion of agreement among orthopaedic surgeons on operative or nonoperative treatment., Design: Web-based reliability study., Setting: Independent orthopaedic surgeons from several countries were invited to classify scapular fractures in an online survey., Participants: One hundred three orthopaedic surgeons evaluated 35 movies of three-dimensional computerized tomography reconstruction of selected scapular fractures, representing a full spectrum of fracture patterns., Main Outcome Measurements: Fleiss kappa (κ) was used to assess the reliability of agreement between the surgeons., Results: The overall agreement on the OTA/AO classification was moderate for the types (A, B, and C, κ = 0.54) with a 71% proportion of rater agreement (PA) and for the 9 groups (A1 to C3, κ = 0.47) with a 57% PA. For the New International Classification, the agreement about the intraarticular extension of the fracture (Fossa (F), κ = 0.79) was substantial and the agreement about a fractured body (Body (B), κ = 0.57) or process was moderate (Process (P), κ = 0.53); however, PAs were more than 81%. The agreement on the treatment recommendation was moderate (κ = 0.57) with a 73% PA., Conclusions: The New International Classification was more reliable. Body and process fractures generated more disagreement than intraarticular fractures and need further clear definitions.

Background: Current anterior fixators can close a disrupted anterior pelvic ring. However, these anterior constructs cannot create posterior compressive forces across the sacroiliac joint. We explored whether a modified fixator could create such forces., Questions/purposes: We determined whether (1) an anterior external fixator with a second anterior articulation (X-frame) would provide posterior pelvic compression and (2) full pin insertion would deliver higher posterior compressive forces than half pin insertion., Methods: We simulated AP compression Type III instability with plastic pelvis models and tested the following conditions: (1) single-pin supraacetabular external fixator (SAEF) using half pin insertion (60 mm); (2) SAEF using full pin insertion (120 mm); (3) modified fixator with X-frame using half pin insertion; (4) modified fixator using full pin insertion; and (5) C-clamp. Standardized fracture compression in the anterior and posterior compartment was performed as in previous studies by Gardner. A force-sensitive sensor was placed in the symphysis and posterior pelvic ring before fracture reduction and the fractures were reduced. The symphyseal and sacroiliac compression loads of each application were measured., Results: The SAEF exerted mean compressions of 13 N and 14 N to the posterior pelvic ring using half and full pin insertions, respectively. The modified fixator had mean posterior compressions of 174 N and 222 N with half and full pin insertions, respectively. C-clamp application exerted a mean posterior load of 407 N., Conclusions: Posterior compression on the pelvis was improved using an X-frame as an anterior fixation device in a synthetic pelvic fracture model., Clinical Relevance: This additive device may improve the initial anterior and posterior stability in the acute management of unstable and life-threatening pelvic ring injuries.

The quality of care of seriously injured persons in Germany is nationally and internationally recognized to be at a high level. However, there are local discrepancies. In 2006 the German Association of Trauma Surgery published the White Paper for the Management of the Seriously Injured. The goal of the paper is a further increase in the quality of care of seriously injured persons. A crucial point of the publication is the call to establish regional trauma networks in Germany. Work on this project has been carried out in eastern Bavaria since spring 2007. The first meeting of the Trauma Network of eastern Bavaria took place in July 2007. On 3rd September 2008 the university hospital of Regensburg was the first clinic audited in Germany. To date nearly 75% of all hospitals in the trauma network of eastern Bavaria have been audited. The establishment of a regional trauma network is a multifactorial event. Essential factors in the development of the trauma network were found to be the communication between the head physicians and the nomination of an appointee of the regional trauma network. For the head physicians the 9 meetings of the trauma network since July 2007 functioned as the communication platform. These exchanges of the head physicians are necessary to animate a trauma network. The appointee of the regional trauma network--most suitably a member of staff of the speaker of the trauma network--is essential to guarantee communication between meetings and to manage prompt responses to questions from the network. This article describes the experiences gained during the implementation of the trauma network in eastern Bavaria.