WWOM VII: Effectiveness of systemic pharmacotherapeutic interventions in the management of BMS: A systematic review and meta-analysis.

OBJECTIVES: To determine the effectiveness of systemic pharmacotherapeutic interventions compared to placebo in burning mouth syndrome (BMS) randomized controlled trials (RCTs) based on the core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). METHODS: A systematic literature review of RCTs, concerning systemic pharmacotherapeutic interventions for BMS, published from January 1994 through October 2019, and meta-analysis was performed. RESULTS: Fourteen RCTs (n = 734 participants) were included. Of those, nine were eligible for the quantitative assessment due to the availability/homogeneity of data for at least one of the IMMPACT domains. Pain intensity was the only domain reported in all RCTs. Weighted mean changes in pain intensity, based on visual analogue scale (ΔVAS), were reported in three RCTs at 6 ± 2 weeks and only one RCT at 10+ weeks follow-ups. Quantitative assessment, based on ΔVAS, yielded very low evidence for the effectiveness of alpha-lipoic acid and clonazepam, low evidence for effectiveness of trazodone and melatonin, and moderate evidence for herbal compounds. CONCLUSIONS: Based on the RCTs studied, variable levels of evidence exist that suggest that select pharmacological interventions are associated with improved symptoms. However, the underreporting of IMMPACT domains in BMS RCTs restricts the multidimensional assessment of systemic interventions outcomes. Standardized outcome measures need to be applied to future RCTs to improve understanding of intervention outcomes.

WWOM VII: Effectiveness of topical interventions in the management of burning mouth syndrome: A systematic review.

OBJECTIVES: To assess the effectiveness of topical interventions in the management of burning mouth syndrome (BMS), based on the core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). METHODS: A systematic literature review of RCTs on topical interventions for the management of BMS, published in PubMed, Web of Science, PsycInfo, Cochrane Database/Central, and Google Scholar through May 2021 was performed. RESULTS: Eight RCTs (n = 358 study participants) were included in this study. Due to underreporting of IMMPACT domains, publication bias, high degree of heterogeneity between studies, meta-analysis was not undertaken. Based on changes in visual analogue pain scores (ΔVAS), the most reported outcome, the effectiveness of the topical interventions was demonstrated; however, it is low level of evidence. CONCLUSIONS: High levels of variability (interventions, outcomes, outcome measurement tools, and intervention effects evaluated), heterogeneity, publication bias, and underreporting of IMMPACT domains were observed across the RCTs. This systematic review highlights the need for application of standardized outcome measures to future RCTs. At the present time, there is lack of moderate-strong evidence on short- and long-term outcomes to support or refute the use of any particular topical intervention in managing BMS. Future RCTs with standardized outcome measures are needed.

The Effect of Proximal Row Carpectomy and Trapeziectomy on First Ray Stability: A Cadaveric Study.

PURPOSE: Wrist and thumb pathology can coexist leading to potential indications for proximal row carpectomy (PRC) and trapeziectomy. In this setting, the axial stability of the first ray is not known. We sought to evaluate axial subsidence of the first metacarpal in cadavers following trapeziectomy and trapeziectomy with PRC to determine the mechanical effects of the procedures performed concurrently. METHODS: Eleven fresh-frozen cadaveric distal forearm specimens were used in this study. The specimens were fixed in cement and mounted to a material test system frame. A predetermined force (20 N) was applied to the thumb metacarpal to simulate forces observed with lateral pinch. Axial displacement of the thumb metacarpal was measured. The application of force was repeated following trapeziectomy on each hand and then again following PRC. Analysis was performed to compare thumb metacarpal subsidence of the 3 groups: native, trapeziectomy, and trapeziectomy with PRC. RESULTS: Before trapeziectomy, native cadaver specimens had an average of 5.1 ± 1.9 mm of thumb metacarpal subsidence under the material test system load (20 N), compared to 16.2 ± 3.4 mm following trapeziectomy, and 25.0 ± 5.5 mm for trapeziectomy with PRC. CONCLUSION: We observed a significant increase in thumb metacarpal subsidence following concurrent trapeziectomy with PRC when compared to trapeziectomy alone. Our results suggest that performing both operations together would lead to a substantial risk of first ray subsidence. CLINICAL RELEVANCE: When treating concurrent basilar thumb and wrist arthritis, it may be more effective to stage the procedures or use a form of thumb metacarpal suspension or arthrodesis.

Effects of Ballistocardiogram Peak Detection Jitters on the Quality of Heart Rate Variability Features: A Simulation-Based Case Study in the Context of Sleep Staging.

Heart rate variability (HRV) features support several clinical applications, including sleep staging, and ballistocardiograms (BCGs) can be used to unobtrusively estimate these features. Electrocardiography is the traditional clinical standard for HRV estimation, but BCGs and electrocardiograms (ECGs) yield different estimates for heartbeat intervals (HBIs), leading to differences in calculated HRV parameters. This study examines the viability of using BCG-based HRV features for sleep staging by quantifying the impact of these timing differences on the resulting parameters of interest. We introduced a range of synthetic time offsets to simulate the differences between BCG- and ECG-based heartbeat intervals, and the resulting HRV features are used to perform sleep staging. Subsequently, we draw a relationship between the mean absolute error in HBIs and the resulting sleep-staging performances. We also extend our previous work in heartbeat interval identification algorithms to demonstrate that our simulated timing jitters are close representatives of errors between heartbeat interval measurements. This work indicates that BCG-based sleep staging can produce accuracies comparable to ECG-based techniques such that at an HBI error range of up to 60 ms, the sleep-scoring error could increase from 17% to 25% based on one of the scenarios we examined.

Diagnostic accuracy of a portable device (Bruxoff®) to measure sleep bruxism.

BACKGROUND: Diagnosis of sleep bruxism (SB) challenges clinicians every day due to multiple forms of assessment tools available, including self-reported questionnaires, clinical examinations, portable devices and laboratory polysomnography (PSG). PSG has become the gold standard for evaluating SB, but it can be limited due to cost and restricted accessibility which often is characterised by long waiting times. Hence, there is a need for the development of a reliable method that can assess SB in a simple and portable manner, which would offer acceptable sensitivity and specificity to evaluate SB. OBJECTIVE: The objective of this study was to investigate reliability and validity of the Bruxoff® device for the diagnosis of SB compared to the PSG. METHODS: Forty-nine subjects underwent one night of polysomnographic study with simultaneous recording with the Bruxoff® device. Rhythmic masticatory muscle activity (RMMA) index was scored according to published criteria. Pearson correlation, Bland-Altman plot and receiver operating characteristic (ROC) curve outcomes were used to quantify the agreement between both methods. RESULTS: Receiver operating characteristic analysis showed an acceptable accuracy for the Bruxoff® with sensitivity of 83.3% and specificity of 72% when the cut-off was set at two events per hour. Pearson correlation analysis showed a nearly significant correlation between PSG and Bruxoff® for RMMA index (r = .282 p = .071) and for total SB episodes per night (r = .295 p = .058). Additionally, the Bland-Altman plot revealed a consistent and systematic difference in the measurement of events between devices. CONCLUSION: The Bruxoff® device appears to be a promising diagnostic method for clinical use, but further study is needed.

Bed-Based Ballistocardiography: Dataset and Ability to Track Cardiovascular Parameters.

BACKGROUND: The goal of this work was to create a sharable dataset of heart-driven signals, including ballistocardiograms (BCGs) and time-aligned electrocardiograms (ECGs), photoplethysmograms (PPGs), and blood pressure waveforms. METHODS: A custom, bed-based ballistocardiographic system is described in detail. Affiliated cardiopulmonary signals are acquired using a GE Datex CardioCap 5 patient monitor (which collects ECG and PPG data) and a Finapres Medical Systems Finometer PRO (which provides continuous reconstructed brachial artery pressure waveforms and derived cardiovascular parameters). RESULTS: Data were collected from 40 participants, 4 of whom had been or were currently diagnosed with a heart condition at the time they enrolled in the study. An investigation revealed that features extracted from a BCG could be used to track changes in systolic blood pressure (Pearson correlation coefficient of 0.54 +/- 0.15), dP/dtmax (Pearson correlation coefficient of 0.51 +/- 0.18), and stroke volume (Pearson correlation coefficient of 0.54 +/- 0.17). CONCLUSION: A collection of synchronized, heart-driven signals, including BCGs, ECGs, PPGs, and blood pressure waveforms, was acquired and made publicly available. An initial study indicated that bed-based ballistocardiography can be used to track beat-to-beat changes in systolic blood pressure and stroke volume. SIGNIFICANCE: To the best of the authors' knowledge, no other database that includes time-aligned ECG, PPG, BCG, and continuous blood pressure data is available to the public. This dataset could be used by other researchers for algorithm testing and development in this fast-growing field of health assessment, without requiring these individuals to invest considerable time and resources into hardware development and data collection.

World Workshop on Oral Medicine VII: Burning mouth syndrome: A systematic review of disease definitions and diagnostic criteria utilized in randomized clinical trials.

OBJECTIVE: To conduct a systematic review analyzing disease definitions and diagnostic criteria used in randomized controlled trials (RCTs) involving burning mouth syndrome (BMS). METHODS: A systematic search conducted in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar that included RCTs on BMS published between 1994 and 2017 was performed. RESULTS: Considerable variability in BMS disease definitions and diagnostic criteria used created substantial heterogeneity in the selection of participants and weakened the rigor of the 36 RCTs identified. The analyzed RCTs routinely under-reported the methods used to rule in or out study participants and the number of individuals excluded from BMS RCTs. CONCLUSIONS: Our findings indicate that a large proportion of participants enrolled in these studies may have had an underlying condition that could have explained their BMS symptoms. Thus, outcomes of therapeutic interventions from these BMS RCTs should be interpreted with caution due to heterogeneous disease definitions and diagnostic criteria. In order to improve the quality of clinical trials, future research should focus on establishing consensus for a single definition of BMS that includes specific inclusion and exclusion criteria that should be used to select study participants for clinical trials.

World Workshop in Oral Medicine VII: Reporting of IMMPACT-recommended outcome domains in randomized controlled trials of burning mouth syndrome: A systematic review.

OBJECTIVES: To determine the frequency of use of the core outcome domains published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in burning mouth syndrome (BMS) randomized controlled trials (RCTs). METHODS: This systematic review, conducted as part of the World Workshop on Oral Medicine VII (WWOM VII), was performed by searching the literature for studies published in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar from January 1994 (when the first BMS definition came out) through October 2017. RESULTS: A total of 36 RCTs (n = 2,175 study participants) were included and analyzed. The overall reporting of the IMMPACT core and supplemental outcome domains was low even after the publication of the IMMPACT consensus papers in 2003 and 2005 (mean before IMMPACT consensus publication = 2.6 out of 6; mean after IMMPACT publication = 3.8 out of 6). Use of validated assessment tools recommended by the IMMPACT consensus was scarce (1.9 out of 6). None of the RCTs reviewed cited the IMMPACT consensus papers. CONCLUSIONS: The underreporting of IMMPACT outcome domains in BMS RCTs is significant. Raising awareness regarding the existence of standardized outcome domains in chronic pain research is essential to ensure more accurate, comparable, and consistent interpretation of RCT findings that can be clinically translatable.

Vitamin D Deficiency in Pregnant Ukrainian Women: Effects of Alcohol Consumption on Vitamin D Status.

OBJECTIVE: Heavy alcohol consumption can alter vitamin D status; however, the relationships between alcohol consumption and vitamin D concentrations in pregnant women have not been well studied. The aim of this study was to investigate the vitamin D status in a population of alcohol-exposed (N = 180) and low/unexposed control (N = 179) Ukrainian pregnant women. METHODS: Women who attended prenatal care facilities in 2 regions of Ukraine (Rivne and Khmelnytsky) for a routine prenatal visit were screened for the study. At the time of enrollment (20.4 ± 7.0 weeks of gestation), blood samples and alcohol consumption data (during a typical week around conception and the most recent 2 weeks) were collected. Vitamin D status was assessed by 25-hydroxyvitamin D [25(OH)D] concentrations. RESULTS: A high prevalence of suboptimal vitamin D status in pregnant Ukrainian women was observed. Overall, 50.1% and 33.4% of the women were classified as vitamin D deficient [25(OH)D < 20 ng/mL] or insufficient [25(OH)D ≥ 20 ng/mL and ≤30 ng/mL], respectively, based on 2011 Endocrine Society guidelines. Alcohol-exposed women had significantly lower 25(OH)D concentrations than low/unexposed women in Spring (p = 0.006) and Winter (p = 0.022). When vitamin D concentrations were grouped into sunny season (Summer + Fall) compared to not sunny season (Winter + Spring), there was a significant ethanol by season interaction (p = 0.0028), with alcohol-drinking women having lower circulating vitamin D compared to low/unexposed women in seasons of low sun availability. CONCLUSIONS: These data suggest that when vitamin D concentrations are generally low (e.g., during seasons of low sun availability), alcohol consumption during pregnancy has a negative impact on vitamin D status.

Somatosensory and affective contributions to emotional, social, and daily functioning in chronic pain patients.

OBJECTIVE: The present study tested the independent and interactive contributions of the somatosensory component of pain (pain intensity) and the affective component of pain (pain unpleasantness) on emotional, social, and daily functioning in chronic pain patients. SUBJECTS: Participants were 472 patients seeking treatment for chronic orofacial pain. Mean age of the sample was 46.0 years (standard deviation [SD] = 14.67, range 18-78), with 82.2% female. Average pain duration at the time of initial appointment was 75.7 months (SD = 106.66). METHODS: Participants completed self-report measures of pain intensity, unpleasantness, and functional outcomes at the time of their first appointment. These data were later extracted from participant's de-identified medical records. Multivariate linear regression was used to test the interaction of pain intensity and unpleasantness on outcome measures of emotional, social, and daily functioning. RESULTS: Results revealed that pain intensity contributed to poorer functional outcomes but higher levels of social support even after controlling for pain unpleasantness. After controlling for pain intensity, unpleasantness was associated with higher pain interference and affective distress. There was also pain intensity by unpleasantness interaction on pain interference. Specifically, at lower levels of pain unpleasantness, changes in pain intensity produced greater changes in pain interference than they did at higher levels of pain unpleasantness. CONCLUSIONS: Results suggest that both intensity and unpleasantness contribute unique variance to functional outcomes. The results highlight the importance of interventions that not only try to reduce pain levels but also reduce levels of pain unpleasantness.

Pain Intensity Moderates the Relationship Between Age and Pain Interference in Chronic Orofacial Pain Patients.

UNLABELLED: BACKGROUND/STUDY CONTEXT: Chronic pain is associated with increased interference in daily functioning that becomes more pronounced as pain intensity increases. Based on previous research showing that older adults maintain well-being in the face of pain as well as or better than their younger counterparts, the current study examined the interaction of age and pain intensity on interference in a sample of chronic orofacial pain patients. METHODS: Data were obtained from the records of 508 chronic orofacial pain patients being seen for an initial evaluation from 2008 to 2012. Collected data included age (range: 18-78) and self-reported measures of pain intensity and pain interference. Bivariate correlations and regression models were used to assess for statistical interactions. RESULTS: Regression analyses revealed that pain intensity positively predicted pain interference (R(2) = .35, B = 10.40, SE = 0.62, t(507) = 16.70, p < .001). A significant interaction supported the primary hypothesis that aging was associated with reduced interference at high levels of pain intensity (ΔR(2) = .01, B = -1.31, SE = 0.63, t(505) = -2.90, p = .04). CONCLUSION: At high levels of pain intensity, interference decreased with age, although the age by pain intensity interaction effect was small. This evidence converges with aging theories, including socioemotional selectivity theory, which posits that as people age, they become more motivated to maximize positive emotions and minimize negative ones. The results highlight the importance of studying the mechanisms older adults use to successfully cope with pain.

Use of controlled diaphragmatic breathing for the management of motion sickness in a virtual reality environment.

Evidence indicates that activation of the parasympathetic nervous system (PNS) suppresses physiological responses associated with motion sickness. Research also shows paced breathing increases PNS activation; the current study examines the use of paced diaphragmatic breathing (DB) training to quell motion sickness symptoms. Healthy participants (N = 60) were pre-screened for motion sickness susceptibility. Participants were then randomly assigned to either a control condition, focusing on environmental awareness, or to an experimental condition implementing paced DB. Following this, participants were exposed to a virtual reality (VR) motion sickness experience, while heart rate variability, breathing rate (RPM), and motion sickness ratings were collected. Results demonstrated participants in the DB condition had higher PNS activation and reported fewer motion sickness symptoms during the VR experience than the participants in the control condition. Results suggest that the DB protocol can be used to significantly increase PNS tone and decrease the development of motion sickness symptoms.

Understanding the relationship between religiousness, spirituality, and underage drinking: the role of positive alcohol expectancies.

Research has consistently found that religiousness and spirituality are negatively associated with underage drinking. However, there is a paucity of research exploring the mechanisms by which these variables influence this important outcome. With 344 underage young adults (ages 18-20; 61 % women), we investigated positive alcohol expectancies as a mediator between religiousness and spirituality (measured separately) and underage alcohol use. Participants completed the Religious Commitment Inventory-10, Daily Spiritual Experiences Scale, Alcohol Expectancies Questionnaire, and Drinking Styles Questionnaire. Results indicate less positive alcohol expectancies partially mediate the relationship between both religiousness and spirituality and underage alcohol use. This suggests religiousness and spirituality's protective influence on underage drinking is partly due to their influence on expectations about alcohol's positive effects. Since underage drinking predicts problem drinking later in life and places one at risk for serious physical and mental health problems, it is important to identify specific points of intervention, including expectations about alcohol that rise from religious and spiritual factors.

Whole unstimulated salivary flow rate decreases during acute stressful condition.

OBJECTIVE: To examine the influence of acute stress on salivary flow using a validated stressor paradigm. STUDY DESIGN: This uniform crossover study consisted of 40 healthy adults who underwent the Trier Social Stress Test, consisting of a 5-minute mental arithmetic task (MAT), and a nonstressful task (NST), consisting of a 5-minute free speech task. The order of the tasks was counterbalanced and unstimulated whole saliva (UWS) was measured in 2 groups of 20 participants during each 5-minute task condition, with a 10-minute washout period between tasks. At baseline, mathematical ability was self-reported and psychological distress was measured using the Symptom Checklist-90-Revised. Heart rate (HR) and breathing rate (BR) were recorded during each task. RESULTS: Age, sex, HR, BR, and psychological distress were similar between groups at baseline (P > .05). During the MAT, HR increased significantly and mean UWS flow rate decreased significantly compared with the NST (P < .001). CONCLUSIONS: An acute psychobiological stressor task was associated with a rapid decrease in salivary flow in adults. Thus, stress can contribute to reduced salivary flow and should be considered as a factor during the diagnostic workup of patients who complain of a dry mouth.

The incidence and prevalence of temporomandibular disorders and posterior open bite in patients receiving mandibular advancement device therapy for obstructive sleep apnea.

PURPOSE: This study aims to evaluate the incidence and prevalence of temporomandibular disorders (TMD) in patients receiving a mandibular advancement device (MAD) to treat obstructive sleep apnea using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). In addition, it also aims to assess the development of posterior open bite (POB). MATERIALS AND METHODS: Data from 167 patients were evaluated at baseline, from 159 patients after 118 days (visit II), from 129 patients after 208 days (visit III), and from 85 patients after 413 days (visit IV). The presence of TMD symptoms was evaluated through a questionnaire. TMD signs were assessed using the RDC/TMD. Clinical evaluation assessed for the presence of POB. RESULTS: The prevalence of TMD was 33/167 (19.8 %) at baseline. After an initial decrease to 14.5 % on visit II, the prevalence increased to 19.4 % on visit III and finally demonstrated a decrease to 8.2 % on visit IV. The incidence of TMD was 10.6 % on visit II. This decreased on further visits and only two (1.9 %) patients developed TMD from visit III to visit IV. POB was found to develop with an average incidence of 6.1 % per visit. The prevalence of POB was 5.8 % on visit II, 9.4 % on visit III, and 17.9 % on visit IV. CONCLUSION: The use of MADs may lead to the development of TMD in a small number of patients. Nevertheless, these signs are most likely transient. Patients with pre-existing signs and symptoms of TMD do not experience significant exacerbation of those signs and symptoms with MAD use. Furthermore, these may actually decrease over time. POB was found to develop in 17.9 % of patients; however, only 28.6 % of these patients were aware of any bite changes.

A preliminary study of cigarette smoking in female orofacial pain patients.

The relationship between behavior (eg, diet, exercise, substance use) and the functioning of chronic-pain patients, including orofacial-pain patients, is poorly understood. This preliminary study examined cigarette smoking and both pain-related and psychological functioning in female orofacial-pain patients. Correlates of intentions to quit smoking were also explored. There were 48 participants in this cross-sectional study. Smokers reported significantly less self-control over pain (d = .66), lower general activity levels (d = .52), more fatigue (d = .80), and poorer sleep quality (d = .53) than non-smokers. The mean effect size for all dependent variables was .49 (range, .33-.80) with the smallest and largest effect found for negative mood and fatigue, respectively. More positive attitudes toward smoking cessation independently predicted stronger intentions to quit (ß = .52, p = .03). Findings suggest smoking is significantly associated with pain-related and psychological functioning in female orofacial-pain patients. Smoking-cessation treatment for these patients should include motivational interviewing techniques directed toward attitudinal change.

Cardiac autonomic function associated with treatment adherence after a brief intervention in patients with chronic pain.

The goal of this study was to investigate psychophysiological characteristics in chronic pain patients during a pain stressor (cold pressor test) and after a brief diaphragmatic breathing intervention. Laboratory procedures were designed to quantify the effects of diaphragmatic breathing training at six breaths per minute on cardiac autonomic reactivity as indexed by root mean square of successive differences (RMSSD) and sequential baroreflex sensitivity (sBRS). Participants (n = 22) completed an initial laboratory assessment including the diaphragmatic breathing training session and were instructed to practice the technique for three ten-minute sessions daily. Self-monitoring of the use of the technique along with daily pain and fatigue scores was accomplished with hand-held computers. Participants returned to the lab for a second assessment after two-weeks. Participants demonstrating improved resting physiological status as indexed by change in RMSSD and sBRS after training (improvers) were compared to those not demonstrating any change in these variables (non-improvers). After two weeks of training, the improvers showed higher tolerance (p < .05) and lower blood pressure reactivity to the cold pressor test (p < .05) compared to the non-improvers. Time spent practicing the breathing technique was significantly different between the groups with the improvers maintaining daily practice close to the intervention recommendations. These results suggest the potential for significant improvements in autonomic functioning and inhibitory response to stress after a single intervention session and two weeks of practice.

De Quervain's Tenosynovitis in Primary Caregivers.

INTRODUCTION: The purpose of this study is to evaluate the incidence of de Quervain's tenosynovitis in newborn caregivers - both male and female - as well as potential associated factors, such as child's age or weight and lactation status. METHODS: Surveys were administered from August 2014 to April 2015 to parents with young children in the greater Buffalo, New York area. Parents were asked to report wrist pain symptoms and location, number of hours spent caregiving, child's age, and lactation status. Participants who reported wrist pain performed a self-guided Finkelstein test and completed a QuickDASH questionnaire. RESULTS: One-hundred twenty-one surveys were returned: 9 from males and 112 from females. Ninety respondents reported no wrist/hand pain (group A), 11 reported wrist/hand pain and a negative Finkelstein test (group B), and 20 reported wrist/hand pain and a positive Finkelstein test (group C). The mean QuickDASH score in group B was significantly smaller than that of group C. On average, child age was statistically significantly different across categories of pain with the oldest population in the positive Finkelstein group (group C) (272.8 ± 196.5 vs 481.9 ± 488.9, P = 0.007). CONCLUSIONS: This study supports the hypothesis that mechanical components of newborn caregiving play a major role in the development of postpartum de Quervain's tenosynovitis. It also supports the concept that hormonal changes in the lactating female are not an important contributor to the development of postpartum de Quervain's tenosynovitis. Our results, as well as previous studies, suggest a high index of suspicion for the condition must be maintained when seeing primary caregivers with wrist pain.