Definition of the Post-COVID syndrome using a symptom-based Post-COVID score in a prospective, multi-center, cross-sectoral cohort of the German National Pandemic Cohort Network (NAPKON).

PURPOSE: The objective examination of the Post-COVID syndrome (PCS) remains difficult due to heterogeneous definitions and clinical phenotypes. The aim of the study was to verify the functionality and correlates of a recently developed PCS score. METHODS: The PCS score was applied to the prospective, multi-center cross-sectoral cohort (in- and outpatients with SARS-CoV-2 infection) of the "National Pandemic Cohort Network (NAPKON, Germany)". Symptom assessment and patient-reported outcome measure questionnaires were analyzed at 3 and 12 months (3/12MFU) after diagnosis. Scores indicative of PCS severity were compared and correlated to demographic and clinical characteristics as well as quality of life (QoL, EQ-5D-5L). RESULTS: Six hundred three patients (mean 54.0 years, 60.6% male, 82.0% hospitalized) were included. Among those, 35.7% (215) had no and 64.3% (388) had mild, moderate, or severe PCS. PCS severity groups differed considering sex and pre-existing respiratory diseases. 3MFU PCS worsened with clinical severity of acute infection (p = .011), and number of comorbidities (p = .004). PCS severity was associated with poor QoL at the 3MFU and 12MFU (p < .001). CONCLUSION: The PCS score correlated with patients' QoL and demonstrated to be instructive for clinical characterization and stratification across health care settings. Further studies should critically address the high prevalence, clinical relevance, and the role of comorbidities. TRAIL REGISTRATION NUMBER: The cohort is registered at www. CLINICALTRIALS: gov under NCT04768998.

Multidisciplinary rehabilitation with a focus on physiotherapy in patients with Post Covid19 condition: an observational pilot study.

There is a lack of interventions that treat the Post-Covid-19 Condition (PCC) itself. Accordingly, treatment guidelines recommend physiotherapy interventions to alleviate symptoms and enhance functioning. In cases where unimodal treatments prove ineffective, non-organ-specific multidisciplinary bio-psycho-social rehabilitation (MBR) programs are a suitable option. In a pilot observational study with assessments at the entry and end of treatment we aimed to evaluate the feasibility of a 3-week day clinic MBR program and explore its effects on physical functioning in PCC patients with fatigue and reduced physical capacity. Patient selection was based on an interdisciplinary assessment involving a physician, a psychologist and a physiotherapist. Feasibility was determined based on full participation (≥ 8 of 9 days) and maintenance of stable endurance in the 6-Minute Walk Test (6MWT). From 37 patients included in the study, 33 completed the MBR (mean age: 43 ± 12 years, 73% female). Four patients discontinued the MBR, with two of them having reported deterioration of PCC symptoms. The 6MWT showed a numerical improvement from 501 ± 97 m to 512 ± 87 m, although it did not reach statistical significance. These results support the feasibility of outpatient MBR with a focus on active physiotherapy interventions in PCC patients with fatigue. This study aligns with previous research supporting the effectiveness of physiotherapy and rehabilitation in PCC patients. However, further research is needed to address possible different treatment responses and varying treatment approaches in subgroups of PCC patients.

U-Net based vessel segmentation for murine brains with small micro-magnetic resonance imaging reference datasets.

Identification and quantitative segmentation of individual blood vessels in mice visualized with preclinical imaging techniques is a tedious, manual or semiautomated task that can require weeks of reviewing hundreds of levels of individual data sets. Preclinical imaging, such as micro-magnetic resonance imaging (µMRI) can produce tomographic datasets of murine vasculature across length scales and organs, which is of outmost importance to study tumor progression, angiogenesis, or vascular risk factors for diseases such as Alzheimer's. Training a neural network capable of accurate segmentation results requires a sufficiently large amount of labelled data, which takes a long time to compile. Recently, several reasonably automated approaches have emerged in the preclinical context but still require significant manual input and are less accurate than the deep learning approach presented in this paper-quantified by the Dice score. In this work, the implementation of a shallow, three-dimensional U-Net architecture for the segmentation of vessels in murine brains is presented, which is (1) open-source, (2) can be achieved with a small dataset (in this work only 8 µMRI imaging stacks of mouse brains were available), and (3) requires only a small subset of labelled training data. The presented model is evaluated together with two post-processing methodologies using a cross-validation, which results in an average Dice score of 61.34% in its best setup. The results show, that the methodology is able to detect blood vessels faster and more reliably compared to state-of-the-art vesselness filters with an average Dice score of 43.88% for the used dataset.

Second opinion and time to knee arthroplasty: a prospective cohort study of 142 patients.

OBJECTIVE: The objective of this study was to determine the impact of obtaining a second opinion consultation on time to knee arthroplasty (KA). We further examined the frequency of KA and the determinants of KA following the second opinion. DESIGN: Prospective cohort study. SETTING: The second opinion programme was implemented at the Ludwig Maximilian University Hospital in Munich. PARTICIPANTS: Participants comprised patients with knee osteoarthritis who were insured with one of the largest statutory health insurance Allgemeine Ortskrankenkasse Bayern (mean age 64.3±9.6 years). Patients participated in a second-opinion programme and completed questionnaires on site before and after personal presentation for the second opinion consultation. Follow-up questionnaires were delivered by post at 3 and 12 months after the second opinion consultation. Of the 142 patients included in the study, 47 (33.1%) underwent KA within 12 months after obtaining the second opinion. PRIMARY OUTCOME MEASURES: Primary outcome measure was time until patients received KA. Cox proportional hazard modelling was used to calculate the associations between the selected predictors and time that elapsed between receipt of the second opinion to KA. RESULTS: Mean time until KA was 17 weeks. Kaplan-Meier curves showed significant differences in time to KA according to the recommendation given at second opinion consultation, knee-related quality of life and Kellgren-Lawrence grade. In multivariate Cox proportional hazard modelling, second opinion recommendation (HR 5.33, 95% CI 1.16, 24.41) and knee-related quality of life (HR 1.03, 95% CI 1.01, 1.06) were significant predictors of time from second opinion to KA. CONCLUSIONS: Obtaining a second opinion had significant impact on time to knee replacement. Those who were recommended immediate surgery also underwent surgery more quickly after the second opinion. The effect of knee-related quality of life supports the importance of patient-reported outcome measures in the decision for or against KA.

Chronic low back pain: a prospective study with 4 to 15 years follow-up after a multidisciplinary biopsychosocial rehabilitation program.

BACKGROUND: Multidisciplinary biopsychosocial rehabilitation (MBR) in patients with chronic low back pain (CLBP) is superior to less intensive treatments for at least one year, but the long-term course of the disease is largely unknown. The primary aim of this study was to describe the long-term course of an MBR in relation to pain, disability, and quality of life from the beginning of an MBR to between 4 to 15 years after participation. The secondary aim was to explore the long-term course of an MBR in relation to physiological outcomes of functioning. METHODS: This was a observational study conducted at a university hospital. The cohort consisted of participants of a 3-week, CLBP-specific MBR program between August 2001 and January 2013. The North American Spine Society questionnaire (NASS) pain and disability scale was the primary patient -reported outcome measure (PROM). The NASS neurogenic symptoms scale and the Short-Form 36 (SF-36) health survey were secondary PROMs. Patients were assessed before entry to the MBR (T0), at entry (T1), at discharge (T2) and 4 to 15 years after discharge (T3). Effects were quantified by effect size (ES). Score differences were tested for significance using parametric or non-parametric tests and linear mixed models. RESULTS: Of 299 consecutive patients from the MBR program, 229 could be contacted. Of these, 84 declined participation, five did not meet the inclusion criteria, and 26 had incomplete data. Thus, 114 patients were included. The mean follow-up time was 9.2 years. At T3, patients exhibited beneficial effects for NASS pain and disability with a moderate ES (ES = 0.63; p < 0.001). The NASS neurogenic symptoms scale was stable. The SF-36 scales showed an improvement in the bodily pain domain (ES = 1.02; p < 0.001), but no significant changes for physical functioning, physical role, general health, vitality, social functioning, emotional role, or mental health. The physical health component summary was improved (ES = 0.40, p = 0.002), and the mental health summary was unchanged. The linear mixed model analysis confirmed improvements in pain and disability between T1 and T3 (p = 0.010). CONCLUSIONS: The results of this study suggest that there is a long-term benefit of MBR participation in patients with CLBP.

Routine data-based quality indicators for the treatment of gonarthrosis and coxarthrosis patients in the ambulatory care sector - A study protocol for a cluster-randomised pilot trial to evaluate the MobilE-ARTH study.

BACKGROUND: In 2019, Germany had the highest rate of hip replacement surgery and the fourth highest rate of knee replacement surgery among more than 30 OECD countries. The age-standardised rates were estimated at 174 hip joint and 137 knee joint replacements per 100,000 population. Against this background, the contrast between financial incentives for surgery and missing incentives for non-surgical treatment options is repeatedly discussed. Quality indicators (QIs) can serve to measure and transparently present the quality of evidence-based care. Comparing results in the form of audit and feedback has been shown to improve e.g. guideline-compliant ambulatory care. Existing QIs targeting the care of gon- and coxarthrosis mainly focus on discharge management after joint replacement surgery and/or require additional data collection. Therefore, as part of the MobilE-ARTH project, a set of QIs for ambulatory care prior to joint replacement surgery calculable based on routine data is being developed. The present study's aim is to evaluate the impact of this QI set in terms of providing feedback on the quality of care. METHODS: The MobilE-ARTH project comprises (Phase 1) developing a QI set following the RAND/UCLA Appropriateness Method, (Phase 2) implementing the QIs in established physician networks of a German statutory health insurance (SHI) within a prospective, non-blinded, cluster-randomised pilot study, and (Phase 3) evaluating the QI set's effectiveness. The physicians in the intervention networks will (a) receive feedback reports providing information about the routine data-based QIs of their gon- and/or coxarthrosis patients and aggregated results for their network, and (b) be invited to two voluntary, facilitated network meetings. In these network meetings, the physicians can use the information provided on the feedback reports to discuss multiprofessional care pathways for patients with gon- and/or coxarthrosis. Selected indicators of the QI set will serve as primary and secondary outcome measures. Routine data will be analysed within multi-level models using an intention-to-treat approach. DISCUSSION: Feedback reports help maintaining clinical standards and closing the gap between evidence and medical practice, thus enabling an overall improvement in health care. Providing physicians with QI-based information on quality of care promotes identifying strengths and weaknesses in medical treatments. TRIAL REGISTRATION: German Clinical Trials Register, number DRKS00027516 , Registered 25th January 2022 - Prospectively registered.

Behavioural and patient-individual determinants of quality of life, functioning and physical activity in older adults (MobilE-TRA 2): study protocol of an observational cohort study in a tertiary care setting.

INTRODUCTION: Vertigo, dizziness and balance problems (VDB) as well as osteoarthritis (OA) are among the health conditions with the greatest impact on mobility and social participation in older adults. Patients with VDB and OA were shown to benefit from specialised care such as vestibular rehabilitation therapy or joint replacement. However, these effects are not permanent and seem to disappear over time. One important reason might be a decreasing adherence to therapy recommendations. Findings from behavioural economics (BE) can help to shed light on individual effects on adherence behaviour and long-term outcomes of VDB and OA. OBJECTIVE: Based on insights from BE concepts (ie, self-efficacy, intention, and time and risk preferences), MobilE-TRA 2 investigates the determinants of functioning and health-related quality of life (HRQoL) 3 and 12 months after discharge from total hip replacement (THR)/total knee replacement (TKR) in patients with OA and after interdisciplinary evaluation for VDB. METHODS AND ANALYSIS: MobilE-TRA 2 is a longitudinal observational study with data collection in two specialised tertiary care centres at the university hospital in Munich, Germany between 2020 and 2023. Patients aged 60 and older presenting for their first THR/TKR or interdisciplinary evaluation of VDB at Ludwig Maximilians University (LMU) hospital will be recruited for study participation. Three and twelve months after baseline assessment, all patients will receive a follow-up questionnaire. Mixed-effect regression models will be used to examine BE concepts as determinants of adherence, HRQoL and functioning. ETHICS AND DISSEMINATION: The study was approved by the ethics committee at the medical faculty of the LMU Munich under the number 20-727. Results will be published in scientific, peer-reviewed journals and at national and international conferences. Findings will also be disseminated via newsletters, the project website and a regional conference for representatives of local and national authorities.

Effects of a medical second opinion programme on patients' decision for or against knee arthroplasty and their satisfaction with the programme.

BACKGROUND: German social legislation gives patients the right to obtain a second opinion before elective surgery and defines quality criteria for reimbursement by statutory health insurances. However, the effects of second opinions before elective surgery are largely unknown. The aim of this study was to evaluate the effects of a second opinion programme in patients recommended for knee arthroplasty. METHODS: The largest statutory health insurance funds in Bavaria offered patients who had been recommended to have knee arthroplasty the opportunity to partake in a second opinion programme which consisted of an in person presentation to an experienced knee surgeon. In this cohort study, consecutive patients from this second opinion programme who signed informed consent were included from 07/10/2016 to 14/02/2020. Data were collected before and after the second opinion visit. RESULTS: A total of 141 (66%) of 215 patients who presented for a second opinion participated in the evaluation study. The second opinion physician recommended knee arthroplasty to 40% of the patients, later knee arthroplasty if the conditions worsened to 40%, and no knee arthroplasty to 20%. After receiving the second opinion 28 of 56 (41%) undecided patients preferred knee arthroplasty, 14 no knee arthroplasty, 14 remained undecided. Four of 46 patients with a preference for "arthroplasty" changed their decision to "no arthroplasty", five of 35 patients from "no arthroplasty" to "arthroplasty". The patients were more confident in their decision according to the decision confidence scale (before: 5.4 ± 3.0; after: 7.8 ± 2.5; p < 0.001). They rated their satisfaction with the second opinion programme with a mean grade of 1.35 (± 0.60) (best:1; worst:6). Logistic regression analyses showed that the recommendation of the second opinion physician for joint arthroplasty was associated with the guideline criteria radiological severity of osteoarthritis (p = 0.001) and knee-joint-specific quality of life (p = 0.041). CONCLUSION: The second opinion of an experienced knee surgeon frequently deviates from the initial recommendation for knee arthroplasty. The association of guideline criteria to the second recommendation suggests a high quality of the second opinion. From the patient perspective, the second opinion reduces uncertainties in their treatment decision.

Is multidisciplinary rehabilitation for low back pain effective in patients above 65 years? An observational cohort study with 12-month follow-up.

BACKGROUND: In contrast to the broad evidence for the effectiveness of multidisciplinary biopsychosocial rehabilitation (MBR) in chronic low back pain (CLBP) patients of working age, little is known about the benefit in patients aged ≥65 years. AIM: To quantify the short-term and 12-month effects of a 3-week CLBP specific MBR program in patients ≥65 years of age; to compare the effects in patients ≥65 years of age to the effects in younger patients. DESIGN: Observational prospective cohort study. SETTING: Outpatient clinic at a tertiary physical medicine and rehabilitation center. POPULATION: Consecutive patients with CLBP who participated in a CLBP specific MBR program. METHODS: The 3-week MBR program included 44 hours of treatment. The primary outcomes pain and disability were measured by the North American Spine Society Questionnaire (NASS). Secondary outcome measures were the Short-Form 36 (SF-36) and the numerical rating scale for pain. Effects were quantified using effect sizes (ES). RESULTS: From 203 included patients, 104 patients older than 65 years (mean: 70.7; SD=4.0) were compared to 99 patients younger than 65 years (mean: 56.4; SD=6.7). The older patients had more comorbidities (two or more comorbidities: 49.5% versus 23.5%; P<0.001). Both groups showed significant improvements in pain and disability at discharge (both groups: P<0.001) and at the 12 months' follow-up (old: P<0.001; young: 0.039) with slightly higher effects for the older patients compared to the younger patients (discharge: ES=0.67 versus ES=0.53; 12 months: ES=0.42 versus ES=0.29). Both groups also improved in the SF-36 Physical Component Summary with slightly lower effects for the older patients (discharge: ES =0.31, P<0.001 versus ES=0.43, P<0.001; 12 months: ES=0.27, P=0.025 versus ES=0.39, P=0.001). The group differences of the change scores were not significant in any of the outcome measures. CONCLUSIONS: MBR shows similar improvements in pain and disability in patients aged ≥ 65 compared to younger patients for at least 12 months. CLINICAL REHABILITATION IMPACT: The findings support the concept of MBR in the growing population of CLBP patients older than 65 years of age.

Prognostic factors for the improvement of pain and disability following multidisciplinary rehabilitation in patients with chronic neck pain.

BACKGROUND: Recent clinical studies have demonstrated the effectiveness of specific, multidisciplinary, bio-psychosocial, rehabilitation programmes for chronic neck pain. However, prognostic factors for the improvement of pain and disability are mostly unknown. Therefore, the aim of this study was to explore prognostic factors associated with improvements in chronic neck pain following participation in a three-week, multidisciplinary, bio-psychosocial, rehabilitation programme. METHODS: In this observational, prospective cohort study, a total of 112 patients were assessed at the beginning, end, and 6 months following the completion of a multidisciplinary, bio-psychosocial, rehabilitation programme. Inclusion for participation in the rehabilitation programme depended upon an interdisciplinary pain assessment. The primary outcome was neck pain and disability, which was measured using the Northern American Spine Society questionnaire for pain+disability and was quantified with effect sizes (ES). Multivariable linear regression analyses were used to explore potential prognostic factors associated with improvements in pain and disability scores at discharge and at the 6-month follow-up period. RESULTS: The mean age of the patients was 59.7 years (standard deviation = 10.8), and 70.5% were female. Patients showed improvement in pain+disability at discharge (ES = 0.56; p < 0.001), which was sustained at the 6-month follow-up (ES = 0.56; p < 0.001). Prognostic factors associated with improvement in pain+disability scores at discharge included poor pain+disability baseline scores (partial, adjusted correlation r = 0.414, p < 0.001), older age (r = 0.223, p = 0.024), a good baseline cervical active range-of-motion (ROM) (r = 0.210, p < 0.033), and improvements in the Short-form 36 mental health scale (r = 0.197; p = 0.047) and cervical ROMs (r = 0.195, p = 0.048) from baseline values. Prognostic factors associated with improvements in pain+disability at the 6-month follow-up were similar and included poor pain+disability baseline scores (partial, adjusted correlation r = 0.364, p < 0.001), improvements in the Short-form 36 mental health scale (r = 0.232; p = 0.002), cervical ROMs (r = 0.247, p = 0.011), and better cervical ROM baseline scores. However, older age was not a factor (r = 0.134, p = 0.172). CONCLUSIONS: Future prognostic models for treatment outcomes in chronic neck pain patients should consider cervical ROM and mental health status. Knowledge of prognostic factors may help in the adoption of individualized treatment for patients who are less likely to respond to multidisciplinary rehabilitation.

Microcurrent therapy in the treatment of knee osteoarthritis: could it be more than a placebo effect? A randomized controlled trial.

BACKGROUND: Microcurrent therapy (MCT) is a novel electrotherapy modality with very low current-levels that may reduce pain especially in joints and muscles. AIM: The aim of this study is to explore potential effects of MCT on pain in patients with knee osteoarthritis, to explore effects of different treatment parameters and to distinguish them from placebo-effects. DESIGN: Randomized four arms controlled clinical trial. SETTING: Outpatient tertiary medical care center. POPULATION: Fifty-six patients with knee OA (Kellgren-Lawrence Score II or III, 14 male and 38 female, mean age: 71.7±7.3 years, pain intensity higher than Numeric Rating Scale [NRS] score 3 from 10). METHODS: Patients were randomized into four groups: MCT with 100 µA (group A), MCT with 25 µA (group B), sham-treatment (group C) and a control-group without intervention. Treatment groups received 10 sessions of MCT for 30 minutes each over a period of 22 days. The primary outcome was daily pain intensity throughout the treatment period measured by a NRS from 0-10. Second outcome measurements were the Knee Osteoarthritis Outcome Score (KOOS), the SF-36 Questionnaire, the Six-Minute Walking Test and the Get-Up-and-Go Test. RESULTS: Evening pain was reduced significantly in the verum-groups compared to sham group (Group A vs. Group C: P<0.001, Group B vs. Group C: P=0.006) and to no intervention (Group A vs. Group D: P<0.001, Group B vs. Group D: P=0.002). The difference between sham-therapy and no therapy was not significant. In the pre-post analysis of the KOOS group A improved significantly in the subscale Symptoms. Group A and B and D improved in the Activities of Daily Living subscale. CONCLUSIONS: The results of this RCT suggest that MCT has beneficial effects on pain in patients with knee osteoarthritis that are not explained by a placebo effect. Due to the explorative, pilot character of the study, further confirmation is needed before clear recommendations can be given. CLINICAL REHABILITATION IMPACT: More high-quality RCTs with transparent parameters should be investigated to elucidate potential effects of MCT in the field of physical medicine and rehabilitation. At the present time MCT is a treatment option that could be helpful, in particular for patients who are afraid of unpleasant sensations from electrotherapy with stronger currents.

Multidisciplinary biopsychosocial rehabilitation in chronic neck pain: a naturalistic prospective cohort study with intraindividual control of effects and 12-month follow-up.

BACKGROUND: In contrast to the large evidence of the effectiveness of multidisciplinary biopsychosocial rehabilitation (MBR) in chronic low back pain, little is known about the effects of MBR in chronic neck pain (CNP). AIM: To quantify short-term and 12-month effects of a 3-week CNP-specific MBR program. DESIGN: Naturalistic prospective observational cohort study with intraindividual control of effects. SETTING: Outpatient clinic at a tertiary physical medicine and rehabilitation center. POPULATION: Consecutive patients with CNP (N.=81) who participated in a CNP-specific MBR. METHODS: The intervention was a MBR outpatient clinic program. Primary Outcome was the North American Spine Society (NASS) questionnaire pain/function scale. Secondary outcomes included the NASS scale neurogenic symptoms, Short-Form 36 Health Survey (SF-36) and numerical rating scales (NRS) for maximum and average pain. Short-term changes of health were quantified using effect sizes (ES), which were corrected by the change during waiting time before MBR. RESULTS: At the end of treatment, the NASS pain/function scale showed significant improvement (P<0.001) by a moderate corrected ES (ES=0.59). Moderate significant improvements were also found for the NASS scale neurogenic symptoms (ES=0.65), the SF-36 scales bodily pain (ES=0.56) and mental health (ES=0.54), and the NRS maximum pain (ES=0.59). Significant small corrected ES were found for the SF-36 scales physical functioning (ES=0.32), physical role (ES=0.41), vitality (ES=0.42), social functioning (ES=0.41), emotional role (ES=0.41) and the NRS average pain (ES=0.48). The improvement on the SF-36 scale general health was not significant (ES=0.19). At the follow-up after 12 months, the NASS pain/function scale remained its moderate ES (ES=0.52, P value <0.001). Also, the NASS Scale neurogenic symptoms, the SF-36 scales bodily pain, general health, social functioning and mental health and both NRS pain scales showed significant benefits. CONCLUSIONS: This study showed that MBR may be effective in patients with CNP. Maintenance of moderate benefits in pain and function seems possible for at least 12 months. CLINICAL REHABILITATION IMPACT: The findings support the concept of CNP-specific MBR.

Progressive resistance training in cachectic head and neck cancer patients undergoing radiotherapy: a randomized controlled pilot feasibility trial.

BACKGROUND: Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purposes of this pilot randomized controlled trial were to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy and to explore possible risks and benefits. METHODS: Twenty cachectic participants with head and neck cancer receiving radiation were randomized to obtain either a machine supported progressive resistance training (n = 10) or usual care (n = 10). The training took place 3 times weekly for 30 min. Intervention included 3 exercises for major muscle groups with 8-12 repetition maximum for 3 sets each. Bioelectrical impedance analysis, hand-held dynamometry, Six-Minute Walk Test and standardized questionnaires for fatigue and quality of life were used for evaluating outcomes at baseline before radiotherapy (t1), after 7 weeks of radiotherapy (t2) and 8 weeks after the end of radiotherapy (t3). RESULTS: All participants (n = 20) completed the trial. No serious adverse events occurred. At the initial assessment the cachectic patients had already lost 7.1 ± 5.2% of their body weight. General fatigue (score 10.7 ± 3.3) and reduced quality of life (score 71.3 ± 20.6) were prevalent in cachectic head and neck cancer patients even before radiotherapy. An average improvement of weight loading for leg press (+ 19.0%), chest press (+ 29.8%) and latissimus pull-down (+ 22.8%) was possible in the intervention group. Participants had at least 13 training sessions. The outcome measures showed nonsignificant changes at t2 and t3, but a trend for a better course of general fatigue and quality of life at t2 in the intervention group. CONCLUSIONS: Despite advanced tumor stage and burdensome treatment the intervention adherence is excellent. Progressive resistance training in cachectic head and neck cancer patients during radiotherapy seems to be safe and feasible and may have beneficial effects of general fatigue and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03524755 . Registered 15 May 2018 - Retrospectively registered.

European validation of The Comprehensive International Classification of Functioning, Disability and Health Core Set for Osteoarthritis from the perspective of patients with osteoarthritis of the knee or hip.

PURPOSE: To validate the International Classification of Functioning, Disability and Health Comprehensive Core Set for Osteoarthritis from the patient perspective in Europe. MATERIALS AND METHODS: This multicenter cross-sectional study involved 375 patients with knee or hip osteoarthritis. Trained health professionals completed the Comprehensive Core Set, and patients completed the Short-Form 36 questionnaire. Content validity was evaluated by calculating prevalences of impairments in body function and structures, limitations in activities and participation and environmental factors, which were either barriers or facilitators. Convergent construct validity was evaluated by correlating the International Classification of Functioning, Disability and Health categories with the Short-Form 36 Physical Component Score and the SF-36 Mental Component Score in a subgroup of 259 patients. RESULTS: The prevalences of all body function, body structure and activities and participation categories were >40%, >32% and >20%, respectively, and all environmental factors were relevant for >16% of patients. Few categories showed relevant differences between knee and hip osteoarthritis. All body function categories and all but two activities and participation categories showed significant correlations with the Physical Component Score. Body functions from the ICF chapter Mental Functions showed higher correlations with the Mental Component Score than with the Physical Component Score. CONCLUSIONS: This study supports the validity of the International Classification of Functioning, Disability and Health Comprehensive Core Set for Osteoarthritis. Implications for Rehabilitation Comprehensive International Classification of Functioning, Disability and Health Core Sets were developed as practical tools for application in multidisciplinary assessments. The validity of the Comprehensive International Classification of Functioning, Disability and Health Core Set for Osteoarthritis in this study supports its application in European patients with osteoarthritis. The differences in results between this Europe validation study and a previous Singaporean validation study underscore the need to validate the International Classification of Functioning, Disability and Health Core Sets in different regions of the world.

Electromyogram Biofeedback in Patients with Fibromyalgia: A Randomized Controlled Trial.

BACKGROUND/AIM: Electromyogram (EMG) biofeedback is used in chronic pain but its effectiveness in patients with fibromyalgia is unclear. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of EMG biofeedback in patients with fibromyalgia. METHODS: Patients were recruited from a waiting list at the fibromyalgia day care clinic at the University Hospital Munich. The study intervention comprised 14 sessions of EMG biofeedback during 8 weeks in addition to the usual care. The control intervention was usual care alone. Assessments were scheduled before intervention (T0), after intervention (T1), and 3 months after the end of intervention (T2). The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcome measures included additional patient-oriented measures and the pressure-pain threshold in the trapezius muscles. Effectiveness was analyzed by significance tests and standardized effect sizes (ES). RESULTS: 36 patients completed the study. EMG biofeedback did not improve the health status (FIQ, T1: p = 0.95, ES = 0.02; T2: p = 0.52, ES = 0.26). Among the secondary outcome measures, only the pressure-pain threshold at the trapezius muscles showed an improvement in the intervention group (T1: p = 0.016, ES = 0.84). CONCLUSION: EMG biofeedback showed no health status improvement in patients with fibromyalgia.

Parental bonding and alexithymia in adults with fibromyalgia.

In a cross-sectional study, the authors investigated 40 female patients with fibromyalgia syndrome (FS) for the degree of alexithymia and parental bonding style. Alexithymia was assessed by the Toronto Alexithymia Scale-26; parental style by the FDEB (a German version of the Measure of Parental Style). In 15% of patients with FS, clinically significant alexithymia was found. Also, there was a positive association between the alexithymia scores (TAS total score) and "maternal abuse" and higher values in "paternal indifference," which predicted higher scores on "Difficulties identifying feelings" (TAS). The results of this study suggest that parental styles are associated with higher alexithymia scores.

Characteristics of radial growth and stable isotopes in a single oak tree to be used in climate studies.

In this study we have analyzed the variability of tree-ring widths and stable isotopes (delta(13)C and delta(18)O) of a single sessile oak tree (Quercus petraea (Matt.) Liebl.) since these parameters are critical in reconstructing the environment, particularly climatic conditions. Tree rings were separated into early- and latewood (EW(t); LW(t)), tree ring (TR(t)), and transfer tree ring (TTR(t), the latter being the latewood plus the earlywood of the subsequent year. Mean sensitivity, simple correlation, partial correlation and autocorrelation analyses were applied to describe data and relationships. Although this research focused on a single tree, the results compared well with average site data. Widths and delta(18)O values showed generally low autocorrelation for all tree-ring components, whereas delta(13)C revealed highly significant autocorrelations for most tree-ring components. Mean sensitivity of the standardized values turned out to be high for delta(18)O, marginally lower for width and the lowest for delta(13)C. Correlation analyses have proven that the relationships within the tree-ring widths or within the isotope parameters are much stronger than across widths and isotope parameters. The study demonstrates the unique potential of all measured tree-ring data to be used as climate proxies.

Physical disability due to musculoskeletal conditions.

Musculoskeletal conditions (MSC) are common throughout the world and their impact on individuals is diverse and manifold. Knowledge of the determinants for disability and of strategies for prevention and rehabilitation management according to the scientific evidence is critical for reducing the burden of MSC. The first section of this chapter reviews the evidence for common determinants of functioning and disability in patients with MSC. We have focussed on environmental factors (EF) and personal factors (PF) and have structured them according to the International Classification of Functioning, Disability and Health (ICF) framework. The second section discusses prevention strategies. Generally, prevention needs to address those EF and PF that were presented in the first section. The final section describes modern principles of rehabilitation and reviews the evidence for specific rehabilitation interventions.

Measuring the outcome of health resort programs.

OBJECTIVE: To evaluate the metric properties and practicability of valid, internationally available outcome instruments in the special setting of health resort programs. METHODS: A cohort study in a convenience sample of patients with low back pain, upper back pain, conditions of the lower extremities, and conditions of the upper extremities was conducted. Their functioning and health were assessed before and after a health resort program by the disease-specific North American Spine Society (NASS) instruments Lumbar NASS and Cervical NASS; WOMAC Osteoarthritis Index; Disabilities of Arm, Shoulder and Hand Questionnaire; and the general instrument, Medical Outcome Study Short Form-36 (SF-36). RESULTS: Completeness on the scale level ranged between 1% and 10%. Criterion validity of condition-specific instruments was confirmed by stronger associations of the pain and function scales to the Physical Health component of the SF-36 (r = -0.59 to -0.79, p < 0.001 for all scales) than to the Mental Health component (r = -0.11, NS, to r = -0.42, p < 0.001). Reliability (Cronbach's alpha coefficient) was higher than 0.8 for all scales of condition-specific instruments and for 6 of 8 SF-36 scales. Floor and ceiling effects ranged between 0% and 7%. The condition-specific instruments demonstrated a good responsiveness with an effect size ranging between 0.28 and 0.55 and with a standardized response mean between 0.32 and 0.94. The responsiveness of most SF-36 scales was similar, but the Physical Function scale showed a lower responsiveness than the condition-specific scales. CONCLUSION: The evaluated instruments can be recommended for use in clinical trials that assess the outcome of health resort programs.