Influence of Role Expectancy on Patient-Reported Outcomes Among Patients With Migraine: A Randomized Clinical Trial.

Importance: It is usually assumed that an individual's classification as a patient or a healthy person is determined by the presence or absence of disease, but little is known about whether the mere awareness of being a patient or a healthy control can play an important role for reporting outcomes. Objective: To investigate whether assignment to the role of a patient or a healthy control has an effect on patient-reported outcomes. Design, Setting, and Participants: This single center, double-blind, 3-group randomized clinical trial included consecutive patients from a tertiary headache clinic based at a single center in Germany who were invited to participate between October 2019 and June 2023. Statistical analysis was performed from January to March 2024. Intervention: Patients with migraine were randomized into 2 groups. The first group was told that this study was centered on migraine symptoms, whereas the second group was told that healthy controls were being sought for a study about patients with vertigo. A third group of age- and sex-matched headache-free participants served as controls. All participants viewed 2 standardized roller coaster videos and provided ratings of their perceived levels of motion sickness and dizziness. Main Outcomes and Measures: The primary outcome was self-reported vestibular symptoms. Secondary outcomes included differences in motion sickness, headache burden, and migraine disability. Outcomes were assessed using standardized questionnaires. Results: The final sample included 366 participants: 122 patients with migraine assigned the role of patient (MP) (migraine as patient): mean [SD] age, 37.56 [12.93] years; 105 [86.1%] female), 122 patients with migraine assigned the role of healthy participant (MH) (migraine as healthy): mean [SD] age, 37.03 [13.10] years; 107 [87.7%] female), and 122 headache-free controls (HC): mean [SD] age, 37.55 [11.56] years; 100 [82.0%] female). The assigned role of the individuals with migraine (MP vs MH) had a significant effect on self-disclosure of (1) estimation that symptoms (dizziness) will occur under specific conditions (self-reported vestibular symptoms: 79 MP [64.8%]; 29 MH [23.8%]; 9 HC [7.4%]; P < .001), (2) the increase of such symptoms (dizziness) after viewing the roller coaster video, and (3) the reported frequency (median [IQR] self-reported monthly headache days for MP: 7 [4-15] days; for MH: 5 [2-10] days; P = .008) and severity (median [IQR] migraine disability assessment score for MP: 35 [20-64] points; for MH: 25 [11-47] points; P = .005) of migraine symptoms. Statistically significant changes were also found for self-reported headache frequency and disability caused by migraine. Conclusions and Relevance: This randomized clinical trial found an effect of expectations regarding the role of a patient with respect to clinical and study outcomes. These findings suggest that role expectations should be taken into account when, for example, invasive treatments are discussed. Trial Registration: ClinicalTrials.gov Identifier: NCT06322550.

Availability, Quality, and Evidence-Based Content of mHealth Apps for the Treatment of Nonspecific Low Back Pain in the German Language: Systematic Assessment.

BACKGROUND: Nonspecific low back pain (NSLBP) carries significant socioeconomic relevance and leads to substantial difficulties for those who are affected by it. The effectiveness of app-based treatments has been confirmed, and clinicians are recommended to use such interventions. As 88.8% of the German population uses smartphones, apps could support therapy. The available apps in mobile app stores are poorly regulated, and their quality can vary. Overviews of the availability and quality of mobile apps for Australia, Great Britain, and Spain have been compiled, but this has not yet been done for Germany. OBJECTIVE: We aimed to provide an overview of the availability and content-related quality of apps for the treatment of NSLBP in the German language. METHODS: A systematic search for apps on iOS and Android was conducted on July 6, 2022, in the Apple App Store and Google Play Store. The inclusion and exclusion criteria were defined before the search. Apps in the German language that were available in both stores were eligible. To check for evidence, the apps found were assessed using checklists based on the German national guideline for NSLBP and the British equivalent of the National Institute for Health and Care Excellence. The quality of the apps was measured using the Mobile Application Rating Scale. To control potential inaccuracies, a second reviewer resurveyed the outcomes for 30% (3/8) of the apps and checked the inclusion and exclusion criteria for these apps. The outcomes, measured using the assessment tools, are presented in tables with descriptive statistics. Furthermore, the characteristics of the included apps were summarized. RESULTS: In total, 8 apps were included for assessment. Features provided with different frequencies were exercise tracking of prefabricated or adaptable workout programs, educational aspects, artificial intelligence-based therapy or workout programs, and motion detection. All apps met some recommendations by the German national guideline and used forms of exercises as recommended by the National Institute for Health and Care Excellence guideline. The mean value of items rated as "Yes" was 5.75 (SD 2.71) out of 16. The best-rated app received an answer of "Yes" for 11 items. The mean Mobile Application Rating Scale quality score was 3.61 (SD 0.55). The highest mean score was obtained in "Section B-Functionality" (mean 3.81, SD 0.54). CONCLUSIONS: Available apps in the German language meet guideline recommendations and are mostly of acceptable or good quality. Their use as a therapy supplement could help promote the implementation of home-based exercise protocols. A new assessment tool to obtain ratings on apps for the treatment of NSLBP, combining aspects of quality and evidence-based best practices, could be useful. TRIAL REGISTRATION: Open Science Framework Registries sq435; https://osf.io/sq435.

Only cervical vertebrae C0-C2, not C3 are relevant for subgrouping migraine patients according to manual palpation and pain provocation: secondary analysis of a cohort study.

BACKGROUND: Subgrouping of migraine patients according to the pain response to manual palpation of the upper cervical spine has been recently described. Based on the neuroanatomy and the convergence of spinal and trigeminal nerves in the trigeminocervical complex, the cervical segments C1 to C3 are potentially relevant. To date it has not been investigated whether palpation results of all upper cervical segments are based on one underlying construct which allows combining the results of several tests. Therefore, the aim of this secondary analysis of a cohort study was to determine whether results from all three segments form one construct. METHODS: Seventy-one migraine patients with chronic or frequent episodic migraine diagnosed according to the international headache society classification version 3 were examined by one physiotherapist. Manual palpation using a posterior to anterior pressure was performed on the upper three cervical vertebrae unilaterally left and right. The results of the palpation according to the patients' responses were combined using factor analysis. In addition, item response theory (IRT) was used to investigate the structure of the response pattern as well as item difficulty and discrimination. FINDINGS: Factor analysis (principal component) showed that the palpation of C3 loads less onto the underlying construct than the palpation of C1 and C2. Considering a cut-off value > 1.0, the eigenvalues of all three segments do not represent one underlying construct. When excluding the results from C3, remaining items form one construct. The internal consistency of the pain response to palpation of C1 and C2 is acceptable with a Cronbach's alpha of 0.69. IRT analysis showed that the rating scale model fits best to the pain response pattern. The discrimination value (1.24) was equal for all items. Item difficulty showed a clear hierarchical structure between the palpation of C1 and C2, indicating that people with a higher impairment are more likely to respond with referred pain during palpation of C2. CONCLUSION: Statistical analysis confirms that results from the palpation of the cervical segments C1 and C2 in migraine patients can be combined. IRT analysis confirmed the ordinal pattern of the pain response and showed the higher probability of a pain response during palpation of C2. The pain response to C3 palpation is not relevant for unidimensional IRT analysis. TRIAL REGISTRATION: German registry of clinical trials (DRKS00015995), Registered 20. December 2018, https://www.drks.de/drks_web/setLocale_EN.do.

Predicting the outcome of the greater occipital nerve block - an observational study on migraine patients with and without musculoskeletal cervical impairment.

BACKGROUND AND OBJECTIVE: The importance of neck pain and the trigeminocervical complex in migraine is of high pathophysiological interest since a block to the greater occipital nerve is more effective for some primary headaches than others. This observational study hypothesised that the response to manual palpation of the upper cervical spine predicts the efficacy of the greater occipital nerve-block. METHODS: We divided patients, scheduled by a neurologist to receive a greater occipital nerve-block to reduce their migraine symptoms, into three groups: Patients with no pain response to manual palpation of the neck, patients with local pain, and those with referred pain to the head. Primary outcome was the percentage change in headache frequency. Additionally, items from the quantitative sensory testing protocol were included. RESULTS: Eighty-seven chronic migraine patients were recruited consecutively from a specialised outpatient clinic and 71 were included for analyses and stratified into the three groups: No pain (n = 11), local pain (n = 28), and referred pain to the head (n = 32). Overall, patients experienced a reduction of 1.9 headache days per month (SD 3.4, p < 0,0001). The groups differed significantly in the percentage change of headache frequency (p = 0.041) with the "no pain" group showing the largest reduction. The pressure-pain-threshold over C2 and headache on the day of the intervention influenced the outcome significantly (R2 0,27, p = 0,00078). No serious adverse events occurred. Sixty-five percent of the patients had headaches during the examination. The groups did not differ regarding the distribution of patients with neck-pain in absence of migraine at baseline (p = 0.618). CONCLUSION: Patients that were less sensitive to palpation in the cervical region and headache-free on the day of the intervention improved more after the greater occipital nerve-block.Registration: Registered a priori at the German Clinical Trials Register (DRKS00015995).

The Limits of Conscious Deception Detection: When Reliance on False Deception Cues Contributes to Inaccurate Judgments.

People are generally too trusting, which decreases their ability to detect deceit. This suggests that distrust could enhance our deception detection abilities. Yet, a state of distrust may induce deliberative conscious thought. This mode of thinking has been related to worse complex decision making. Hence, we investigate whether contextual distrust decreases the ability to detect deceit via the stronger reliance on consciously held beliefs about which cues betray deception. In two studies, participants were asked to judge videos of either deceiving or truth telling targets. Contextual distrust was manipulated by asking participants to squint their eyes (distrust) or to round their eyes (trust) while watching the videos. Participants' judgments of targets being deceptive or truthful were measured (Studies 1 and 2) and they were asked on what basis they made these judgments (Study 2). Results showed that distrust especially hampers the detection of truth, which is partly due to more reliance on false beliefs about deception cues. These results corroborate the idea that deliberative conscious information processing may hinder truth detection, while intuitive information processing may facilitate it.

Physical therapy and migraine: musculoskeletal and balance dysfunctions and their relevance for clinical practice.

BACKGROUND: Migraine is a primary headache with high levels of associated disability that can be related to a variety of symptoms and comorbidities. The role of physical therapy in the management of migraine is largely unknown. Therefore, the aim of this review is to highlight and critically discuss the current literature and evidence for physical therapy interventions in individuals with migraines. METHODS: A narrative review of the literature was performed. RESULTS: Physical therapists assessing and treating patients with migraine should focus on two primary aspects: (1) musculoskeletal dysfunctions, and (2) vestibular symptoms/postural control impairment. Signs and symptoms of musculoskeletal and/or vestibular dysfunctions are prevalent among individuals with migraines and different disability levels can be observed depending on the presence of aura or increment of the migraine attacks. CONCLUSION: A proper physical examination and interview of the patients will lead to a tailored treatment plan. The primary aim regarding musculoskeletal dysfunctions is to reduce pain and sensitization, and physical therapy interventions may include a combination of manual therapy, exercise therapy, and education. The aim regarding postural control impairment is to optimize function and reduce vestibular symptoms, and interventions should include balance exercises and vestibular rehabilitation. However, consistent evidence of benefits is still lacking due to the lack of and therefore need for tailored and pragmatic clinical trials with high methodological quality.

Can physical testing be used to distinguish between migraine and cervicogenic headache sufferers? A protocol for a systematic review.

INTRODUCTION: Differential diagnosis of migraine and cervicogenic headache (CGH) can be challenging given the large overlap of symptoms, commonly leading to misdiagnosis and ineffective treatment. In order to strengthen the differential diagnosis of headache, previous studies have evaluated the utility of physical tests to examine for musculoskeletal impairment, mainly in the cervical spine, which could be provoking or triggering headache. However, no systematic review has attempted to evaluate whether physical tests can differentiate CGH from migraine or both conditions from asymptomatic subjects. METHODS/ANALYSIS: A systematic review protocol has been designed and is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). A sensitive topic-based search strategy is planned which will include databases, hand searching of key journals and consultation of relevant leading authors in this field. Terms and keywords will be selected after discussion and agreement. Two independent reviewers will perform the search and select studies according to inclusion and exclusion criteria, including any cohort or observational studies evaluating the topic of this review; a third reviewer will confirm accuracy. A narrative synthesis will be developed for all included studies and, if possible, a meta-analysis will be conducted. The overall quality of the evidence will be assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) checklist for diagnostic accuracy studies and the Downs and Black scale for those studies where the QUADAS-2 checklist cannot be applied. ETHICS AND DISSEMINATION: Ethical approval is not required since no patient information will be collected. The results will provide a deeper understanding about the possibility of using physical tests to differentiate cervicogenic headache from migraine and from asymptomatic subjects, which has direct relevance for clinicians managing people with headache. The results will be published in a peer-reviewed journal and presented at scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42019135269.

Which Examination Tests Detect Differences in Cervical Musculoskeletal Impairments in People With Migraine? A Systematic Review and Meta-Analysis.

BACKGROUND: Most patients with migraine report associated neck pain. Whether neck pain is a symptom of migraine or an indicator for associated cervical musculoskeletal impairment has not yet been determined. Physical examination tests to detect cervical impairments in people with headache have been suggested, but results have not been evaluated systematically and combined in meta-analyses. PURPOSE: The purpose of this study was to identify musculoskeletal impairments in people with migraine and people who were healthy (healthy controls) by reviewing published data on physical examination results. DATA SOURCES: PubMed, CINAHL, Web of Science, and the Cochrane Register of Clinical Trials were searched for studies published prior to December 2017. STUDY SELECTION: Publications investigating physical examination procedures that are feasible for use in a physical therapy setting for patients with migraine and healthy controls were independently selected by 2 researchers. DATA EXTRACTION: One researcher extracted the data into predesigned data extraction tables. Entries were checked for correctness by a second researcher. The Downs and Black Scale was used for risk-of-bias assessment by 2 reviewers independently. DATA SYNTHESIS: Thirty-five studies (involving 1033 participants who were healthy [healthy controls] and 1371 participants with migraine) were included in the qualitative synthesis, and 18 were included in the meta-analyses (544 healthy controls and 603 participants with migraine). Overall, studies were rated as having a low to moderate risk of bias. Included studies reported 20 different test procedures. Combined mean effects indicated that 4 of the tests included in the meta-analyses distinguished between patients and controls: range of cervical motion, flexion-rotation, pressure pain thresholds, and forward head posture in a standing position. LIMITATIONS: Manual joint testing and evaluation of trigger points were the 2 most frequently investigated tests not included in the meta-analyses because of heterogeneity of reporting and procedures. CONCLUSIONS: Three tests confirmed the presence of musculoskeletal impairments in participants with migraine when combined in meta-analyses. Pressure pain thresholds added information on sensory processing. Additional tests might be useful but require standardized protocols and reporting.

Impact of interleukin-10 on phenotype and gene expression during early monocyte differentiation into dendritic cells.

BACKGROUND: Cancer is linked to defects in immunosurveillance. Vaccination studies using dendritic cells (DC) try to re-establish immune responses toward tumor cells. Tumor-derived products such as interleukin-10 (IL-10) have inhibitory effects on DC function, and tumor-bearing hosts exhibit a lower number of DCs, suggesting inhibitory effects of tumor-derived factors on the recruitment of precursor cells. MATERIALS AND METHODS: We generated DCs in the presence and absence of IL-10. DCs were then characterized by flow cytometry and cDNA microarray analysis. RESULTS: IL-10 interferes with differentiation of peripheral blood monocytes to DCs and induces cells with a distinct phenotype. Microarray analysis revealed that IL-10 exhibits inhibitory as well as stimulatory effects on the expression of several genes. Addition of IL-10 to the differentiation cocktail induces a sustained inhibitory effect on subsequent maturation stimuli. CONCLUSION: IL-10 inhibits DC function and redirects differentiation of DCs to cells with a different phenotype, thereby reducing the pool of potential DC precursors.

Perinatal hemorrhagic shock after fetal scalp blood sampling.

BACKGROUND: Fetal scalp blood sampling is commonly used for fetal monitoring during labor to identify intrapartum fetal hypoxia. CASE: A male term neonate was monitored by fetal scalp blood sampling because of abnormal cardiotocographic recordings. After emergency cesarean delivery, the newborn presented with severe hemorrhagic shock as a result of fetal anemia from the scalp blood sampling. Two scalp incisions were identified as the bleeding source. The underlying reason for the development of hemorrhagic shock was factor IX-deficiency resulting from spontaneous mutation. The neonate was subsequently discharged a week later without further complications. CONCLUSION: Complications during fetal scalp blood sampling are very rare, but obstetricians and neonatologists should be aware of the potential presence of coagulopathies, especially with the persistence of scalp bleeding after delivery.

The protective nature of pellicle towards toothpaste abrasion on enamel and dentine.

OBJECTIVES: To determine the protective nature of pellicle towards toothpaste abrasion. METHODS: The enamel region of human enamel-dentine blocks was indented with a Knoop diamond and the profile across the enamel-dentine junction was measured. Blocks were either exposed to deionised water or placed onto intra-oral appliances and worn in the mouth to produce in situ pellicles. This was followed by a 10-day period of tooth brushing experiments. Each day, specimens were brushed with a slurry of either Toothpaste A (RDA=90) or Toothpaste B (RDA=204) for 25 cycles (10s) on a brushing machine. This was repeated three times per day for a total of 750 brushing cycles. Between brushing cycles specimens were returned to water or in situ. The geometry of the Knoop indents and the enamel-dentine profile were re-measured and the enamel and dentine wear calculated. Specimens were also prepared for TEM analyses. RESULTS: The mean enamel wear (microm) for Toothpastes A and B (water) was 0.23 and 0.06, and for Toothpastes A and B (in situ) was 0.03 and 0.08, respectively. The mean dentine wear (microm) for Toothpastes A and B (water) was 5.08 and 6.03, and for Toothpastes A and B (in situ) was 1.94 and 1.70, respectively. For Toothpaste A, the presence of in situ pellicle significantly (p<0.05) reduced enamel and dentine wear compared to water and for Toothpaste B, dentine wear was significantly reduced compared to water. After tooth brushing, residues of the in situ pellicle layer could be detected on enamel and dentine surfaces by TEM analysis. CONCLUSIONS: The study has demonstrated for the first time that the presence of pellicle can significantly reduce toothpaste abrasion.