[Effects of pulmonary rehabilitation on dysfunctional respiratory patterns in patients with uncontrolled asthma]. / Effekte der pneumologischen Rehabilitation auf dysfunktionale Atemmuster bei Patienten mit unkontrolliertem Asthma.

PURPOSE: Dysfunctional breathing patterns (DAM) are deviations from physiologic breathing patterns. DAM seem to be associated with lower asthma control. To date, it is unclear what effect inpatient rehabilitation can have on this problem. The aim of this work is to investigate the effect of pulmonary rehabilitation (PR) on DAM. METHODS: The data are based on a randomized controlled trial with a waiting control group. The intervention group (IG) received PR 4 weeks after application approval and the control group (KG) after 5 months. Dysfunctional breathing was assessed by Nijmegen-Questionnaire (NQ). Values ≥ 23 points indicate an existing DAM. Values at the end of rehabilitation (T2) and after three months (T3) were compared (analysis of covariance). Supplemental moderator analysis was performed to examine whether the effect of PR was related to baseline NQ scores. RESULTS: Significant differences in NQ score are found between IG (n=202) and KG (n=210) at T2 (AMD=10.5; 95%CI [9; 12]; d=1.4; p<0.001) and at T3 (AMD=5.8; 95%CI [4.3; 7.3]; d=0.8; p<0.001). There is an interaction effect between the difference in NQ score between the groups at T2 and baseline at T0 (b=5.6; 95%CI [2.2; 11.9]; p<0.001). At T3, this interaction effect was no longer detectable (b=4.5; 95%CI [-3.1; 14.1]; p=807). CONCLUSION: Inpatient, multimodality, and interdisciplinary PR is associated with significant and clinically relevant improvement in DAM both at discharge and 3 months later. In the short term, patients with existing DAM benefit more from PR than patients without DAM.

Marker-Based Method for Analyzing the Three-Dimensional Upper Body Kinematics of Violinists: Reproducibility.

BACKGROUND: Recently, Wolf et al. proposed a novel, marker-based method to analyze the three-dimensional upper-body kinematics of high string players for clinical application. The method provides an objective evaluation of high string players' motor strategies, especially in the shoulder complex, by distinguishing between the scapulothoracic (ST) and glenohumeral (GH) joints, while minimizing skin movement artifacts, marker occlusions, and limitations due to instrument placement. Nevertheless, reproducibility of kinematic measurements is crucial for clinical applications. The aim of this study was to assess the method's reproducibility in terms of reliability and repeatability. METHODS: One healthy professional violinist underwent a total of nine bowing trials in three different laboratory sessions. Each trial was conducted by one of two different examiners. A biomechanical model was applied to motion capture data of the pelvis, thorax, spine, and head, as well as both upper limbs (consisting of the scapula, upper arm, forearm and hand). Reproducibility was assessed by calculating inter- and intra-tester, inter-session, and intra-subject measurement errors for each rotational degree of freedom in the upper-body segments and joints. FINDINGS: Small measurement errors were accepted to be good indicators for reproducibility. Intra- and inter-tester errors were found to be small (< 3° for the most part). Both inter-session and intra-subject repeatability were found to be larger (< 5° for the most part). INTERPRETATION: This study generally showed the novel, marker-based method to have good reproducibility for a healthy violinist. This indicates that the proposed method is a reliable tool for quantifying upper-body movements during violin playing across subjects, examiners, laboratories, and motion capture systems.

Marker-Based Method for Analyzing the Three-Dimensional Upper Body Kinematics of Violinists and Violists: Development and Clinical Feasibility.

AIMS: High string players (violin and viola) often suffer from musculoskeletal disorders. Although 3D motion analysis has proved helpful in diagnosing different musculoskeletal syndromes and identifying injurious movement patterns in violin and viola performance, more detailed analyses of upper body movement strategies and especially of the shoulder complex have not yet been recorded. The use of spherical surface markers on some anatomical landmarks is, however, inappropriate when an instrument is being played. The aim of this study was to develop and evaluate a novel marker-based method for analyzing upper body kinematics of high string players using conditions specific to violin and viola playing. METHODS: A custom upper body marker set was developed and a biomechanical model applied to 3D motion capture data of the pelvis, thorax, spine, head, and both upper limbs (scapula, upper arm, forearm, hand) of 12 professional violinists, to assess its clinical feasibility. FINDINGS: Lumbar and thoracic spine, thorax, neck, and left upper limb were quite static, while extensive motion occurred in the right upper limb. Most rotation angles showed a reasonable intersubject variability except for glenohumeral and wrist joints. Significant differences were observed between G- and D-string bowing, especially in the left wrist and right shoulder joints. INTERPRETATION: This study suggests that the proposed method is a valid tool for quantifying upper body movements in violin and viola performance. With the extended upper body model, it will improve understanding of the motor strategies adopted by high string players and may contribute to injury prevention, diagnosis, and treatment.

Musculoskeletal Health Complaints and Corresponding Risk Factors Among Music Students: Study Process, Analysis Strategies, and Interim Results from a Prospective Cohort Study.

AIM: In this prospective longitudinal study, the physical and psychological health status of music students is assessed at the beginning of their university music study and tracked over time. Analysis strategies and interim results from the first-year cohort, including 1-year incidences, monthly prevalences, and predictors of developing musculoskeletal health complaints (MHC), are presented. METHODS: This prospective longitudinal study is calculated to enlist a total sample of 370 participants, including musicians and non-musicians, over 5 years. Baseline measurements include a self-designed questionnaire, core strength endurance, hypermobility, finger-floor-distance, motor control, mechanosensitivity, health-related quality of life (SF36), and stress and coping inventory (SCI). The occurrence of MHC is based on monthly online questionnaires. RESULTS: The first-year subcohort enrolled 33 music students and 30 non-music control students. The mean monthly completion rate for the questionnaire was 55.7±8.7%. At baseline, music students showed significantly more stress symptoms, reduced physical function¬ing, and increased bodily pain compared to control students. The 1-year incidence of MHC was 59% for music students and 44% for controls. Risk factors for MHC included being a music student, previous pain, reduced physical functioning, stress symptoms, reduced emotional functioning, and mechanosensitivity. Being a music student, physical functioning, sleep duration, positive thinking, and general mechanosensitivity had a predictive ability of 0.77 (ROC curve) for MHC. CONCLUSION: A total of 63 students enrolled in the first cohort is in line with the precalculated sample size. This prospective study design enables the measurement of MHC incidence and provides insight into mechanisms in the development of MHC among music students, including the interaction of physical, psychological, and psychosocial factors.

Potential Relevance of Altered Muscle Activity and Fatigue in the Development of Performance-Related Musculoskeletal Injuries in High String Musicians.

BACKGROUND: Muscle fatigue seems to be a risk factor in the development of performance-related musculoskeletal disorders (PRMDs) in musicians, but it is unclear how muscle activity characteristics change between musicians with and without PRMDs over a prolonged playing period. PURPOSE: To investigate muscle activity patterns in muscles of the arms, shoulder, and back of high string musicians during prolonged performance. METHODS: Fifteen professional or university high string musicians were divided into PRMD and non-PRMD groups. All musicians played a chromatic scale, then an individual "heavy" piece for 1 hr, and finally the chromatic scale again. Surface electromyography (sEMG) data were recorded from 16 muscles of the arm, shoulder, and trunk on both sides of the body. Two parameters were analyzed: the percentage load in relation to the respective maximum force during the chromatic scale, and the low-frequency spectrum to determine the fatigue behavior of muscles during the 1-hr play. RESULTS: Changes in muscle activation patterns were observed at the beginning and end of the trial duration; however, these varied depending on whether musicians had PRMDs or no PRMDs. In addition, low-frequency spectrum changes were observed after 1 hr of playing in the PRMD musicians, consistent with signs of muscular fatigue. CONCLUSION: Differences in muscle activity appear between high string musicians with and without PRMDs as well as altered frequency spectrum shifts, suggesting possible differential muscle fatigue effects between the groups. The applied sEMG analysis proved a suitable tool for detailed analysis of muscle activation characteristics over prolonged playing periods for musicians with and without PRMDs.

Identification of novel immune phenotypes for allergic and nonallergic childhood asthma.

BACKGROUND: Childhood asthma is classified into allergic asthma (AA) and nonallergic asthma (NA), yet both are treated identically, with only partial success. OBJECTIVE: We sought to identify novel immune phenotypes for childhood AA and NA. METHODS: The Clinical Asthma Research Association cohort study includes 275 steroid-naive 4- to 15-year-old German children (healthy control subjects [HCs], patients with AA, and patients with NA). In PBMCs both quantitative and functional analysis of regulatory T (Treg) and TH17 cells (flow cytometry/Treg cell suppression) before/after anti-CD3/CD28, lipid A, and peptidoglycan stimulation were performed. Cytokines and gene expression, as assessed by using Luminex or transcriptomics/quantitative real-time RT-PCR, were analyzed by means of regression analysis. Linear discriminant analysis was applied to discriminate between phenotypes. RESULTS: The 3 phenotypes were immunologically well discriminated by means of microarray and protein analysis with linear discriminant analysis. Patients with AA were characterized by increased Treg cells compared with those in HCs but not those in patients with NA. Treg cells from patients with AA, but not patients with NA, significantly suppressed IL-5, IL-13, and IFN-γ secretion. Patients with AA had decreased expression of chloride intracellular channel 4 (CLIC4) and tuberous sclerosis 1 (TSC1), important innate immunity regulators. Patients with NA were characterized by increased proinflammatory IL-1ß levels, neutrophil counts, and IL-17-shifted immunity. In parallel, expressions of anti-inflammatory IL37, proline-serine-threonine phosphatase-interacting protein 2 (PSTPIP2), and the neutrophil-associated genes CD93, triggering receptor expressed on myeloid cells 1 (TREM1), and regulator of G-protein signaling 13 (RGS13) were increased in patients with NA. A shared TH2 immunity was present in both asthma phenotypes. CONCLUSION: Novel immune-regulatory mechanisms in childhood asthma identified increased Treg cells in patients with AA compared with those in HCs but not those in NA and decreased innate immunity genes for patients with AA, the first potentially indicating a counterregulatory mechanism to suppress cytokines yet not sufficient to control allergic inflammation. Very distinctly, patients with NA showed an IL-17-shifted proinflammatory immunity, promoting neutrophil inflammation and less functional Treg cells. Identification of these unique pathways provides a profound basis for future strategies for individualized prediction of asthma development, disease course, and prevention.

Regulation of TH17 markers early in life through maternal farm exposure.

BACKGROUND: Previous studies suggested that maternal farm exposure during pregnancy modulates early immune development toward an allergy-protective status potentially mediated by TH1 or regulatory T (Treg) cells. However, the underlying mechanisms might involve immune modulation of additional T-cell populations, such as TH17 cells, influenced by genetic predisposition. OBJECTIVE: We examined the role of maternal farm exposure and genetic predisposition on TH17 cell responses to innate and adaptive immune stimulation in cord blood. METHODS: Eighty-four pregnant mothers were recruited before delivery. Detailed questionnaires (60 nonfarming mother, 22 farming mothers, and 2 exclusions) assessed farming exposures. Cord blood was stimulated with lipid A, peptidoglycan (Ppg), or PHA. TH17 lineage (retinoic acid receptor-related orphan receptor C [RORC], retinoic acid receptor-related orphan receptor α [RORA], IL-23 receptor [IL23R], IL17, IL17F, and IL22) and Treg cell markers (forkhead box protein 3 [FOXP3], lymphocyte activation gene 3 [LAG3], and glucocorticoid-induced TNF receptor [GITR]) were assessed at the mRNA level. TH17/Treg/TH1/TH2 cytokines and 7 single nucleotide polymorphisms within the TH17 lineage (RORC, IL23R, and IL17) were examined. RESULTS: TH17 lineage mRNA markers were expressed at birth at low concentrations independent of maternal farm exposure. A positive correlation between TH17 lineage markers and FOXP3 (mRNA) was observed on stimulation (nonfarming mothers: lipid A, Ppg, and PHA; farming mothers: Ppg and PHA), influenced by maternal farming. Specific single nucleotide polymorphisms within the TH17 lineage genes influenced gene expression of TH17 and Treg cell markers and cytokine secretion. CONCLUSIONS: Gene expression of TH17 lineage markers in cord blood was not influenced by maternal farming. Yet TH17 and Treg cell markers were positively correlated and influenced by maternal farm exposure. Our data suggest that prenatal exposures and genetic predisposition play a role during early TH17 immune maturation, potentially regulating the development of immune-mediated diseases, such as childhood asthma.

Adverse Events After Cervical Spinal Manipulation - A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: Cervical manipulations are widely used by physiotherapists, chiropractors, osteopaths, and medical doctors for musculoskeletal dysfunctions like neck pain and cervicogenic headache. The use of cervical manipulation remains controversial, since it is often considered to pose a risk for not only benign adverse events (AEs), such as aggravation of pain or muscle soreness, but also severe AEs such as strokes in the vertebrobasilar or carotid artery following dissections. Studies finding an association between cervical manipulation and serious AEs such as artery dissections are mainly case control studies or case reports. These study designs are not appropriate for investigating incidences and therefore do not imply causal relationships. Randomized controlled trials (RCTs) are considered the gold standard study designs for assessing the unconfounded effects of benefits and harms, such as AEs, associated with therapies. OBJECTIVE: Due to the unclear risk level of AEs associated with high-velocity, low-amplitude (HVLA) cervical manipulation, the aim of this study was to extract available information from RCTs and thereby synthesize the comparative risk of AEs following cervical manipulation to that of various control interventions. STUDY DESIGN: Systematic review and meta-analysis. METHODS: A systematic literature search was conducted in the PubMed and Cochrane databases. This search included RCTs in which cervical HVLA manipulations were applied and AEs were reported. Two independent reviewers performed the study selection, the methodological quality assessment, and the GRADE approach. Incidence rate ratios (IRR) were calculated. The study quality was assessed by using the risk of bias 2 (RoB-2) tool, and the certainty of evidence was determined by using the GRADE approach. RESULTS: Fourteen articles were included in the systematic review and meta-analysis. The pooled IRR indicates no statistically significant differences between the manipulation and control groups. All the reported AEs were classified as mild, and none of the AEs reported were serious or moderate. LIMITATIONS: The search strategy was limited to literature in English or German. Furthermore, selection bias may have occurred, since only PubMed and Cochrane were used as databases, and searching was done by hand. RCTs had to be excluded if the results did not indicate the group in which the AEs occurred. A mandatory criterion for inclusion in the meta-analysis was a quantitative reproduction of the frequencies of AEs that could be attributed to specific interventions. CONCLUSION: In summary, HVLA manipulation does not impose an increased risk of mild or moderate AEs compared to various control interventions. However, these results must be interpreted with caution, since RCTs are not appropriate for detecting the rare serious AEs. In addition, future RCTs should follow a standardized protocol for reporting AEs in clinical trials.

INTENTION TO TREAT ANALYSIS IN CLINICAL RESEARCH: BASIC CONCEPTS FOR CLINICIANS.

ABSTRACT: This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. Additionally, we included studies from manual searches that were already cataloged within the first author's personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.

Musculoskeletal Health Complaints and Associated Risk Factors in Freshmen Music Students.

BACKGROUND: Evidence concerning the development of musculoskeletal health complaints (MHCs) among music students is limited due to inappropriate study designs. We aimed to assess the occurrences of MHCs and associated risk factors in freshmen music students compared to students from other disciplines. METHODS: A prospective cohort study was conducted. Risk factors such as pain-related, physical, and psychosocial variables were measured at baseline. Episodes of MHCs were recorded monthly. RESULTS: A total of 146 music students and 191 students from other disciplines were analyzed. In the cross-sectional comparison, pain-related, physical, and psychosocial variables were significantly altered in music students compared to students from other disciplines. Furthermore, music students with current MHCs differed significantly from music students without current MHCs with respect to physical health, pain, and history of MHCs. Our longitudinal analysis showed that monthly MHCs were higher in music students compared to students from other disciplines. Independent predictors for monthly MHCs in music students were current MHCs and reduced physical function. Predictors for MHCs in students from other disciplines were a history of MHCs and stress. CONCLUSIONS: We provided insight into the development of MHCs and risk factors in music students. This may help in the creation of targeted, evidence-based prevention and rehabilitation.

Influence of different upper cervical positions on electromyography activity of the masticatory muscles.

OBJECTIVE: The aim of this study was to determine the activity of the masseter and anterior temporalis muscles in relation to different positions of the upper cervical spine during maximal voluntary isometric clenching by surface electromyography (EMG). METHODS: This was a cross-sectional study with a repeated-measures design performed using 25 asymptomatic subjects (13 female and 12 male; mean age, 31 years; SD, 8.51). The EMG activity of the masseter and anterior temporalis muscles was recorded bilaterally during maximal clenching at neutral position and during extension, flexion, ipsilateral lateral flexion, contralateral lateral flexion, and ipsilateral and contralateral rotations in maximal flexion. In addition, the upper cervical range of motion and mandibular excursions were assessed. The EMG activity data were analyzed using a 3-way analysis of variance in which the factors considered were upper cervical position, sex (male and female), and side (right and left), and the hypothesis of importance was the interaction side x position. RESULTS: The 3-way analysis of variance detected statistically significant differences between the several upper cervical positions (F = 13.724; P < .001) but found no significant differences for sex (F = 0.202; P = .658) or side (F = 0.86; P = .53) regarding EMG activity of the masseter muscle. Significant differences were likewise observed for interaction side x position for the masseter muscle (F = 12.726; P < .001). The analysis of the EMG activity of anterior temporalis muscle did not produce statistically significant differences (P > .05). CONCLUSION: This preliminary study suggests that the upper cervical movements influence the surface EMG activity of the masseter muscle. These findings support a model in which there are interaction between the craniocervical and the craniomandibular system.

Selection, Confounding, and Attrition Biases in Randomized Controlled Trials of Rehabilitation Interventions: What Are They and How Can They Affect Randomized Controlled Trials Results? Basic Information for Junior Researchers and Clinicians.

ABSTRACT: A thorough knowledge of biases in intervention studies and how they influence study results is essential for the practice of evidence-based medicine. The objective of this review was to provide a basic knowledge and understanding of the concept of biases and associated influence of these biases on treatment effects, focusing on the area of rehabilitation research. This article provides a description of selection biases, confounding, and attrition biases. In addition, useful recommendations are provided to identify, avoid, or control these biases when designing and conducting rehabilitation trials. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used. If not addressed appropriately, biases related to intervention research are a threat to internal validity and consequently to external validity. By addressing these biases, ensuring appropriate randomization, allocation concealment, appropriate retention techniques to avoid dropouts, appropriate study design and statistical analysis, among others, will generate more accurate treatment effects. Based on their impact on clinical results, a proper understanding of these concepts is central for researchers, rehabilitation clinicians, and other stakeholders working on this field.

Performance, Detection, Contamination, Compliance, and Cointervention Biases in Rehabilitation Research: What Are They and How Can They Affect the Results of Randomized Controlled Trials? Basic Information for Junior Researchers and Clinicians.

ABSTRACT: Bias is a systematic error that can cause distorted results leading to incorrect conclusions. Intervention bias (i.e., contamination bias, cointervention bias, compliance bias, and performance bias) and detection bias are the most common biases in rehabilitation research. A better understanding of these biases is essential at all stages of research to enhance the quality of evidence in rehabilitation trials. Therefore, this narrative review aims to provide insights to the readers, clinicians, and researchers about contamination, cointervention, compliance, performance, and detection biases and ways of recognizing and mitigating them. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used.This review provides several strategies to guard against the impact of bias on study results. Clinicians, researchers, and other stakeholders are encouraged to apply these recommendations when designing and conducting rehabilitation trials.

A Physiotherapeutic Approach to Musicians' Health - Data From 614 Patients From a Physiotherapy Clinic for Musicians (INAP/O).

Currently, the treatment of musicians is an interprofessional approach. Playing-related health complaints may impact the performance of a musician. In Germany, a medical consulting hour for musicians exists, but those for athletes in sports medicine are not so common. The diagnosing and treatment procedure within the physiotherapy consultation for musicians follows a specific concept-b and requires knowledge of instruments and musician-specific complaints. Based on the consulting hour in a clinic in Osnabrueck, 614 case reports were part of this sample, of which 558 data sets were complete. The focus of the analysis is the instrument and the primary complaint. Also, the type of therapy is characterized, and the amount is calculated. Primary complaints of musicians, in general, are found most frequently in the spine and upper extremity. Musician complaints are different between instruments. Instrumentalists have a significantly higher chance to suffer from a primary complaint in the area of the upper extremity. Furthermore, the groups without an instrument (e.g., singing or dancing) are developing complaints in the anatomical area which they primarily use. Therefore, these types of therapy were used: physiotherapy, manual therapy, and osteopathy with an average of 5.9 treatment units. This study underpinned the importance of musician-specific physiotherapy as a profession to treat musicians. Also, an interdisciplinary approach is necessary to treat all aspects of complaints.

MusicCohort: Pilot feasibility of a protocol to assess students' physical and mental health in a Canadian post-secondary school of music.

OBJECTIVE: Music-related physical and mental health conditions are common among post-secondary music students, with many studies reporting a prevalence greater than 70%. However, there is currently no consensus on appropriate, validated assessments for this population. The aim of this pilot study was to test the feasibility of an assessment protocol developed for a German longitudinal study with Canadian post-secondary music students, and to compare the health of music students to non-music students. Using a cross-sectional design, first-semester music and non-music control students were recruited at two campuses at the same university. Both groups completed questionnaires and physical testing, including range of motion, core strength, and pressure pain threshold. Nineteen music students and 50 non-music student controls participated in this study. RESULTS: The German protocol is feasible in a Canadian post-secondary setting. Canadian music students demonstrated similar health outcomes to those in the parent study. All participants demonstrated poorer mental and physical quality of life than the Canadian norms, though this was not statistically significant. The results of this study should be confirmed in a larger study. Future studies with larger sample sizes can provide further insight into the health of Canadian music students, providing a basis for prevention and intervention.

Application and utility of a clinical framework for spinally referred neck-arm pain: A cross-sectional and longitudinal study protocol.

BACKGROUND: The clinical presentation of neck-arm pain is heterogeneous with varying underlying pain types (nociceptive/neuropathic/mixed) and pain mechanisms (peripheral/central sensitization). A mechanism-based clinical framework for spinally referred pain has been proposed, which classifies into (1) somatic pain, (2) neural mechanosensitivity, (3) radicular pain, (4) radiculopathy and mixed pain presentations. This study aims to (i) investigate the application of the clinical framework in patients with neck-arm pain, (ii) determine their somatosensory, clinical and psychosocial profile and (iii) observe their clinical course over time. METHOD: We describe a study protocol. Patients with unilateral neck-arm pain (n = 180) will undergo a clinical examination, after which they will be classified into subgroups according to the proposed clinical framework. Standardized quantitative sensory testing (QST) measurements will be taken in their main pain area and contralateral side. Participants will have to complete questionnaires to assess function (Neck Disability Index), psychosocial factors (Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Depression, anxiety and stress scale), neuropathic pain (Douleur Neuropathique 4 Questions, PainDETECT Questionnaire) and central sensitization features (Central Sensitization Inventory). Follow-ups at three, six and 12 months include the baseline questionnaires. The differences of QST data and questionnaire outcomes between and within groups will be analyzed using (M)AN(C)OVA and/or regression models. Repeated measurement analysis of variance or a linear mixed model will be used to calculate the differences between three, six, and 12 months outcomes. Multiple regression models will be used to analyze potential predictors for the clinical course. CONCLUSION: The rationale for this study is to assess the usability and utility of the proposed clinical framework as well as to identify possible differing somatosensory and psychosocial phenotypes between the subgroups. This could increase our knowledge of the underlying pain mechanisms. The longitudinal analysis may help to assess possible predictors for pain persistency.

Influence of attrition, missing data, compliance, and related biases and analyses strategies on treatment effects in randomized controlled trials in rehabilitation: a methodological review.

INTRODUCTION: Attrition, missing data, compliance, and related biases are three interrelated concepts. Previous research has found that these biases can affect the treatment estimates of randomized trials (RCTs). The extent to which the effects of attrition, missing data, compliance and related biases influence effect size estimates in rehabilitation as well as the effect of analytic strategies to mitigate these biases is unknown. EVIDENCE ACQUISITION: To compile and synthetize the empirical evidence regarding the effects of attrition and compliance related biases on treatment effect estimates in rehabilitation RCTs. Electronic searches were conducted. Studies were included if they investigated the effects of attrition, missing data, compliance and related biases on treatment estimates. The seven studies meeting inclusion criteria were coded for type of biases and summarized using a narrative and/or quantitative approach when appropriate. EVIDENCE SYNTHESIS: Findings demonstrated that trials reporting higher levels of attrition (differences in ES: 0.18 [95%CI: 0.15, 0.22 ]), exclusion of participants from analyses (differences in ES: 0.13 [95% CI: -0.03, 0.29]), lack of good control of incomplete outcome data (differences in ES: 0.14 [95%CI: -0.02, 0.30]) and analysis by "as treated"(differences in ES:-0.39 [95%CI: -0.99, 0.2]) or "per protocol" (differences in ES:-0.46 [95%CI: -0.92, 0]) analyses were more likely to have higher effects than those that did not. CONCLUSIONS: These findings suggest that attrition, missing data, compliance, and related biases have an influence in treatment effect estimates in rehabilitation trials. Therefore, these results should be taken into consideration when designing, conducting and reporting trials in the rehabilitation field.

Attrition, missing data, compliance, and related biases in randomized controlled trials of rehabilitation interventions: towards improving reporting and conduct.

INTRODUCTION: Attrition, missing data, compliance, and related biases can influence the magnitude of treatment effects in randomized controlled trials (RCTs). It is unclear which items should be considered when reporting and evaluating the influence of these biases in trial reports in the rehabilitation field. The aim was to describe which individual items considering attrition, missing data, compliance, and related biases are included in quality tools used in rehabilitation research. In addition, we aimed to determine whether the existing reporting guidelines, such as the CONSORT and its extensions include all relevant items related to these biases when reporting RCTs in the area of rehabilitation. EVIDENCE ACQUISITION: Comprehensive literature searches and a systematic approach to identify tools and items looking at attrition, missing data, compliance and related biases in rehabilitation were performed. We extracted individual items linked to these biases from all quality tools. We calculated the frequency of quality items used across tools and compared them to those found in the CONSORT statement and its extensions. A list of items to be potentially added to the CONSORT statement was generated. EVIDENCE SYNTHESIS: Three new tools to assess the conduct and reporting of trials in the rehabilitation field were found. From these tools, 28 items were used to evaluate the reporting as well as the conduct of trials considering attrition, missing data, compliance, and related biases in the rehabilitation field. However, our team found that some of these items lack specificity in the information required and therefore more research is needed to determine a core set of items used for reporting as well as assessing the risk of bias (RoB) of RCT in the rehabilitation field. CONCLUSIONS: Although many items have been described by existing tools and the CONSORT statement (and its extensions) that deal with attrition, missing data, compliance, and related biases, several gaps in reporting were identified. It is crucial that future research investigate a core set of items to be used in the field of rehabilitation to facilitate the reporting as well as the conduct of RCTs.

Somatosensory profiles in patients with non-specific neck-arm pain with and without positive neurodynamic tests.

Despite normal neurological integrity tests, some patients with non-specific neck-arm pain (NSNAP) have heightened nerve mechanosensitivity upon neurodynamic testing. The aim of this study was to determine whether or not a nerve dysfunction is present in patients with positive neurodynamic tests compared to those with negative neurodynamic tests or healthy controls. Somatosensory profiling using quantitative sensory testing (QST) was established in 40 consecutive patients with unilateral NSNAP; 23 had positive upper limb neurodynamic tests (ULNTPOS) and 17 had negative neurodynamic tests (ULNTNEG) and in 26 healthy controls. QST included measurement of thermal and mechanical detection and pain thresholds in the maximal pain area on the symptomatic side as well as the corresponding contralateral area. Fifty-seven percent of patients with NSNAP had positive neurodynamic tests. Somatosensory profiling revealed a loss of function phenotype in NSNAP patients compared to healthy controls both in the maximal pain area and asymptomatic side. Hyperalgesia (cold, heat and pressure) was present bilaterally in both NSNAP groups. Direct comparison between the patient groups revealed no significant differences in somatosensory profiles. However, the ULNTPOS group demonstrated sensory loss compared to healthy controls in more parameters than the ULNTNEG group. The ULNTNEG subgroup represented an intermediate phenotype between ULNTPOS patients and healthy controls in most detection thresholds as well as thermal and pressure pain thresholds. Even though patients with NSNAP present as a spectrum, it remains unclear whether the sensory changes are indicative of a nerve dysfunction/lesion or rather a marker of altered central pain processing.