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Unlabelled: Migraine is prevalent and disabling yet is poorly understood. One way to better understand migraine is to examine its clinical characteristics and potential biomarkers such as gamma-aminobutyric acid (GABA). The primary objective of this study was to explore whether relevant disease characteristics of migraine are associated with brain GABA levels. Twenty adults fulfilling the established diagnostic criteria for migraine and 20 age- and gender-matched controls completed this cross-sectional study. Pain, central sensitization, negative emotional state, and perceived disability were measured using Short-form McGill Pain Questionnaire-2, Central Sensitization Inventory, Depression Anxiety Stress Scales-21, and Headache Impact Test-6, respectively. Secondary analysis of brain GABA levels of the same cohort measured using proton magnetic resonance spectroscopy was conducted. The migraine group had significantly higher scores than the control group on pain, central sensitization, and disability. Correlation analyses showed fair positive association between GABA levels and pain and central sensitization scores. No association was found between GABA levels and emotional state and disability. These findings are preliminary evidence supporting the use of questionnaires and GABA levels in characterizing migraine better and broadening the diagnostic process. These findings also strengthen the rationale for the role of GABA in migraine pathophysiology and corroborate the potential of GABA as a migraine biomarker.Perspective: Higher pain and central sensitization scores were associated with increased brain GABA levels in individuals with migraine. These findings offer preliminary evidence for the usefulness of measuring pain and central sensitization in migraine and provide some support for the possible role of GABA in migraine pathophysiology and its potential as a diagnostic marker. [ABSTRACT FROM AUTHOR]

Background: Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain. Results: We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures. Conclusions: Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. [ABSTRACT FROM AUTHOR]

Objective: Professional appearance is easily modifiable, and might alter the effects of a clinical encounter. We aimed to determine whether professional attire influences a patient's perception of treatment credibility.Methods: We performed a single-blind randomized controlled study on 128 patients with acute non-specific low back pain who were about to receive treatment in primary care. The treating clinician was randomly allocated to wear formal attire (experimental condition) or casual attire (control condition) to the consultation. Clinicians provided a standardized briefing on the rationale behind the patient's forthcoming treatment. Treatment credibility (Credibility and Expectancy Questionnaire) was assessed immediately after this briefing.Results: All patients received the experimental or control condition as allocated and provided complete primary outcome data. Formal attire had no effect on perceived treatment credibility (Mean difference between groups 1.2 [95%CI-1.1 to 3.5]). Age was the only significant predictor of treatment credibility; older patients rated treatment credibility higher (Beta=0.16 [95%CI 0.08 to 0.24]).Conclusion: In a trial setting, whether or not a clinician is formally dressed has no effect on perceptions of treatment credibility in patients with acute low back pain.Practice Implication: Clinicians should dress comfortably without fear of losing credibility. [ABSTRACT FROM AUTHOR]

Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control. We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results. This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619). [ABSTRACT FROM AUTHOR]

Highlights: [•] We examined fear of falling and functional capacity in patients undergoing chemotherapy. [•] Patients were compared to age-matched and senior controls. [•] Cancer patients showed inferior values than the age-matched healthy subjects. [•] Compared to senior controls, patients showed similar to partly increased values. [•] These impairments may put patients at a higher risk for falls. [Copyright &y& Elsevier]