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espanolIntroduccion: la deteccion temprana de la obesidad durante la infancia es de vital importancia para la prevencion de patologias durante la edad adulta. En la actualidad, la evaluacion de la obesidad infantil se realiza principalmente utilizando el indice de masa corporal por edad percentilado, aunque este no aporta informacion sobre la distribucion del tejido adiposo. Un marcador emergente de distribucion de la grasa abdominal es la circunferencia de la cintura (CC). Objetivo: el objetivo de este trabajo fue evaluar las diferencias entre diferentes criterios diagnosticos para definir el sobrepeso y la obesidad con el fin de establecer el punto de corte optimo de la CC en los ninos espanoles.Metodo: se llevo a cabo un estudio observacional transversal de 8241 ninos/as (3-12 anos) en Villanueva de la Canada (Madrid, Espana). Se determinaron el peso, la talla y el perimetro de la cintura atendiendo a los criterios de la Sociedad Internacional para el Avance de la Cineantro-pometria (ISAK). Los valores obtenidos para los criterios diagnosticos (Fundacion Orbegozo (OF), el Grupo Internacional de Obesidad (IOTF) y la Organizacion Mundial de la Salud (OMS)) se compararon utilizando la prueba de McNemar para proporciones emparejadas. El coeficiente kappa (κ) se utilizo para evaluar el grado de acuerdo de las tres clasificaciones. Analizamos la validez del indice de masa corporal (IMC) y el perimetro de la cintura (CC) utilizando el analisis de la curva caracteristica operativa del receptor (ROC). El indice de Youden se utilizo para determinar los valores de corte de la CC que identifican la obesidad infantil.Resultados: se calcularon las prevalencias del sobrepeso y la obesidad de acuerdo con criterios internacionales (IOTF, OMS) y nacionales (FO). Se observo un acuerdo “substancial” para el sobrepeso y la obesidad entre el criterio diagnostico espanol y el IOTF (κ= 0,636), mientras que el acuerdo fue “ligero” entre el criterio espanol y el de la OMS (κ = 0,198). Los puntos de corte de la CC estimados variaron de 54,5 a 88,0 cm, modificandose en funcion de la edad y el sexo. Conclusiones: los puntos de corte de la CC propuestos, establecidos por primera vez para ninos espanoles, son una alternativa simple y valida como criterio diagnostico de obesidad abdominal. EnglishIntroduction: early detection of childhood obesity plays a crucial role in the prevention of diseases during adulthood. At present, the most commonly used screening tool for detecting overweight/obesity in children is the percentile for age of body mass index, although this rate is unable to provide information about fat distribution. An emerging marker of abdominal fat distribution is waist circumference (WC). Objective: the aim of this study was to evaluate the differences between the different diagnostic criteria available to define overweight and obesity in order to establish the optimal WC cut-off values for the Spanish children population. Methods: a cross-sectional study was carried out in 8,241 schoolchildren aged 3 to 12 years from Villanueva de la Canada (Madrid, Spain). WC (cm), weight (kg) and height (cm) were measured according to the recommendations of the Society for the Advancement of Kineanthropometry (ISAK). The values obtained for the diagnostic criteria (Spanish Orbegozo Foundation (OF), the International Obesity Task Force (IOTF), and the World Health Organization (WHO) were compared using McNemar’s test for paired proportions. The kappa coefficient (κ) was used to assess the degree of agreement of the three classifications. We analyzed the validity of body mass index (BMI) and WC using the receiver operating characteristic (ROC) curve analysis. The Youden index was used to determine cut-off values for WC that identify childhood obesity Results: overweight and obesity prevalences were calculated according to the OF, IOTF, and WHO criteria. There was a “substantial” agreement for the overweight and obesity categories between the Spanish criteria and IOTF (κ = 0.636), while agreement was “slight” between the Spanish criteria and those of WHO (κ = 0.198). The estimated cut-off WC criteria ranged from 54.5 to 88.0, varying according to sex and age. Conclusion: the proposed WC cut-off values, stated for the first time in a young Spanish population, are a simple and valid alternative as diagnostic criteria of abdominal obesity.

Background Pulmonary rehabilitation is one of the main interventions to reduce the use of health resources, and it promotes a reduction in chronic obstructive pulmonary disease (COPD) costs. mHealth systems in COPD aim to improve adherence to maintenance programs after pulmonary rehabilitation by promoting the change in attitude and behavior necessary for patient involvement in the management of the disease. Objective This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in COPD patients. Methods COPD patients from three hospitals were randomized to a control group or an intervention group (HappyAir group). Patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. After completion of the process, only the HappyAir group completed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The control group only underwent the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary Disease Assessment Test, St. George’s Respiratory Questionnaire, and EuroQOL-5D), exercise capacity (6-Minute Walk Test), and lung function. Results In total, 44 patients were recruited and randomized in the control group (n=24) and HappyAir group (n=20). Eight patients dropped out for various reasons. The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HappyAir group, which was statistically different compared with the control group at 12 months (56.1 [SD 4.0] vs 44.0 [SD 13.6]; P=.004) after pulmonary rehabilitation. Conclusions mHealth systems designed for COPD patients improve adherence to maintenance programs as long as they are accompanied by disease awareness and patient involvement in management. Trial Registration ClinicalTrials.gov NCT04479930; https://clinicaltrials.gov/ct2/show/NCT04479930

Background Prevalence and severity of allergic diseases have increased worldwide. To date, respiratory allergy phenotypes are not fully characterized and, along with inflammation progression, treatment is increasingly complex and expensive. Profilin sensitization constitutes a good model to study the progression of allergic inflammation. Our aim was to identify the underlying mechanisms and the associated biomarkers of this progression, focusing on severe phenotypes, using transcriptomics and metabolomics. Methods Twenty-five subjects were included in the study. Plasma samples were analyzed using gas and liquid chromatography coupled to mass spectrometry (GC-MS and LC-MS, respectively). Individuals were classified in four groups-"nonallergic," "mild," "moderate," and "severe"-based on their clinical history, their response to an oral challenge test with profilin, and after a refinement using a mathematical metabolomic model. PBMCs were used for microarray analysis. Results We found a set of transcripts and metabolites that were specific for the "severe" phenotype. By metabolomics, a decrease in carbohydrates and pyruvate and an increase in lactate were detected, suggesting aerobic glycolysis. Other metabolites were incremented in "severe" group: lysophospholipids, sphingosine-1-phosphate, sphinganine-1-phosphate, and lauric, myristic, palmitic, and oleic fatty acids. On the other hand, carnitines were decreased along severity. Significant transcripts in the "severe" group were found to be downregulated and were associated with platelet functions, protein synthesis, histone modification, and fatty acid metabolism. Conclusion We have found evidence that points to the association of severe allergic inflammation with platelet functions alteration, together with reduced protein synthesis, and switch of immune cells to aerobic glycolysis.

Gestational Diabetes Mellitus (GDM) causes severe short- and long-term complications for the mother, fetus and neonate, including type 2-diabetes (T2DM) later in life. In this pilot study, GC-Q/MS analysis was applied for plasma metabolomics fingerprinting of 24 healthy and 24 women with GDM at different stages of gestation (second and third trimester) and postpartum (one and three months). Multivariate (unsupervised and supervised) statistical analysis was performed to investigate variance in the data, identify outliers and for unbiased assessment of data quality. Plasma fingerprints allowed for the discrimination of GDM pregnant women from controls both in the 2nd and 3rd trimesters of gestation. However, metabolic profiles tended to be similar after delivery. Follow up of these women revealed that 4 of them developed T2DM within 2 years postpartum. Multivariate PLS-DA models limited to women with GDM showed clear separation 3 months postpartum. In the 2nd trimester of gestation there was also a clear separation between GDM women that were normoglycemic after pregnancy and those with recognized postpartum T2DM. Metabolites that had the strongest discriminative power between these groups in the 2nd trimester of gestation were 2-hydroxybutyrate, 3-hydroxybutyrate, and stearic acid. We have described, that early GDM comprises metabotypes that are associated with the risk of future complications, including postpartum T2DM. In this pilot study, we provide evidence that 2-hydroxybutyrate and 3-hydroxybutyrate may be considered as future prognostic biomarkers to predict the onset of diabetic complications in women with gestational diabetes after delivery.

Objectives Several authors have evaluated different pain measurements, including quantitative sensory testing (QST), temporal summation (TS), and conditioned pain modulation (CPM) in order to determine the presence of central sensitization (CS) and its influence on patients with temporomandibular disorders (TMD). Since there are no convincing studies about this topic, the purpose of this study was to conduct a review of the studies involving CS-related measures in TMD patients. Methods A meta-analysis of case-control and cohort/cross sectional studies was conducted. Standardized mean differences (SMD) and 95% confidence intervals (CIs) were calculated for relevant QST outcomes and pooled in a meta-analysis using the random effects model. Twenty-two studies (eleven case-control and eleven cross sectional studies) met the inclusion criteria; eight were included in the meta-analysis (five cross-sectional and three case-control). Patients with TMD had decreased pressure pain thresholds in both trigeminal (five studies; n = 1,985; SMD = −1.55, 95% CI −2.23 to −0.77; P < 0.01) and remote areas (five studies; n = 1,985; SMD = −1.92, 95% CI −2.95 to −0.89; P < 0.01). When analyzing for thermal hyperalgesia (hot and cold pain thresholds), differences were not found in trigeminal areas or remote areas in patients with TMD. The TS qualitative analysis showed strong evidence of spinal hyperexcitability for mechanically evoked pain. Conclusion These meta-analyses support the existence of differences in widespread pressure pain sensitivity in patients with TMD when compared with asymptomatic subjects. Spinal and central hyperexcitability can be found in TMD patients as shown by an increase in mechanical TS.

Urine fingerprints from Schistosoma mansoni infected and control animals were acquired with ultra performance liquid chromatography-MS (UPLC-MS) and compared with the urine fingerprints obtained by CE by applying the same set of multivariate analysis tools. Principal component analysis of the aligned data provided a time trajectory where the infection was observed after 30 days with UPLC-MS and CE. Two main markers describing infected and control, respectively - phenyl acetyl glycine (PAG) and hippurate - were selected to illustrate the use of orthogonal partial least-square discriminant analysis in determining the discriminatory confidence. PAG was found to be significantly related to the disease (high covariance and correlation), whereas hippurate was found to be nonsignificant as an indicator. Orthogonal partial least-square discriminant analysis models were validated for sensitivity and specificity. Multivariate data analysis derived from two different detection systems showed that CE-UV and UPLC-MS found equivalent results. This work gives additional mechanistic insight into the progress of the S. mansoni infection; the biochemical role and specificity of PAG as a biomarker is yet to be determined.

Fingerprinting together with statistical analysis is often employed to compare samples in metabonomic studies of a disease. Correlation algorithms can aid by extracting information based on the variation patterns of key metabolites. This information can be linked to metabolite identification or to specific up/down-regulated biochemical pathways. Matlab-based software employing the Pearson's correlation algorithm was applied to urine electropherograms from 20 mice infected with the schistosoma parasite. The fingerprints were the sum of electropherograms analysed with normal and reverse polarity, in two different modes MEKC and CZE and with two different capillaries (uncoated and polyacrylamide coated) to provide a broad picture of the samples. Hippurate, a metabolite that was depleted in the infected group and is present in both polarities, was chosen as a test variable; it correlated with itself to a p value of

Schistosoma mansoni infection in mice has been fingerprinted using CE to study the capabilities of this technique as a diagnostic tool for this parasitic disease. Two modes of separation were used in generating the electrophoretic data, with each untreated urine sample the following methods were applied: (i) a fused-silica capillary, operating with an applied potential of 18 kV, in micellar EKC (MEKC) and (ii) a polyacrylamide-coated capillary, operating with an applied potential of -20 kV under zonal CZE conditions. By combining normal and reverse polarities in the data treatment we have extracted more information from the samples, which is a better approach for CE metabolomics. The traditional problems associated with variability in electrophoretic peak migration times for analytes were countered by using a dynamic programming algorithm for the electropherograms alignment. Principal component analyses of these aligned electropherograms and partial least square discriminant analysis (PLS-DA) data are shown to provide a valuable means of rapid and sample classification. This approach may become an important tool for the identification of biomarkers, diagnosis and disease surveillance.

Background: Yogurt has traditionally been considered a probiotic-carrier food with health-promoting effects. Despite the universal assumption of this assertion, several researchers have evaluated the real capability of the yogurt bacteria Lactobacillus delbrueckii subsp bulgaricus and Streptococcus thermophilus to survive and proliferate in the human intestine and have found contradictory results. Objective: This double-blind crossover study assessed the qualitative and quantitative effects of fresh and heat-treated yogurt on bacterial intestinal microbiota from healthy subjects. Design: The subjects were divided into experimental (n = 63) and control (n = 16) groups. The experimental group consumed fresh and heat-treated yogurt for 15 d according to a crossover design with a washout period of 2 wk. Three different fecal samples per individual were recovered: at baseline, after fresh yogurt intake, and after heat-treated yogurt intake. Qualitative changes in microbiota were studied by denaturing gel gradient electrophoresis (DGGE) with universal and lactic acid bacteria (LAB) 16S-rRNA primers. Quantitative changes in LAB, Clostridium coccoides, Clostridium perfringens, and Bacteroides groups were analyzed by real-time polymerase chain reaction. Results: A particular DGGE stable band pattern was observed in each sample. No significant qualitative differences were detected in any fecal sample. However, a significantly higher density of LAB and C. perfringens and a significant decrease in the density of Bacteroides was observed after consumption of both types of yogurt. Microbiota density was not significantly different between the fresh and heat-treated yogurt groups, except for LAB, which was significantly greater in the fresh yogurt group. Conclusion: The main change in human microbiota observed after yogurt consumption was an increase in the density of LAB and C. perfringens to the detriment of Bacteroides. Bacterial changes were not different after the consumption of fresh and heat-treated yogurt.

Background Recent research has shown a relationship of craniomandibular disability with neck-pain-related disability has been shown. However, there is still insufficient information demonstrating the influence of neck pain and disability in the sensory-motor activity in patients with headache attributed to temporomandibular disorders (TMD). The purpose of this study was to investigate the influence of neck-pain-related disability on masticatory sensory-motor variables. Methods An experimental case–control study investigated 83 patients with headache attributed to TMD and 39 healthy controls. Patients were grouped according to their scores on the neck disability index (NDI) (mild and moderate neck disability). Initial assessment included the pain catastrophizing scale and the Headache Impact Test-6. The protocol consisted of baseline measurements of pressure pain thresholds (PPT) and pain-free maximum mouth opening (MMO). Individuals were asked to perform the provocation chewing test, and measurements were taken immediately after and 24 hours later. During the test, patients were assessed for subjective feelings of fatigue (VAFS) and pain intensity. Results VAFS was higher at 6 minutes (mean 51.7; 95% CI: 50.15-53.26) and 24 hours after (21.08; 95% CI: 18.6-23.5) for the group showing moderate neck disability compared with the mild neck disability group (6 minutes, 44.16; 95% CI 42.65-45.67/ 24 hours after, 14.3; 95% CI: 11.9-16.7) and the control group. The analysis shows a decrease in the pain-free MMO only in the group of moderate disability 24 hours after the test. PPTs of the trigeminal region decreased immediately in all groups, whereas at 24 hours, a decrease was observed in only the groups of patients. PPTs of the cervical region decreased in only the group with moderate neck disability 24 hours after the test. The strongest negative correlation was found between pain-free MMO immediately after the test and NDI in both the mild (r = −0.49) and moderate (r = −0.54) neck disability groups. VAFS was predicted by catastrophizing, explaining 17% of the variance in the moderate neck disability group and 12% in the mild neck disability group. Conclusion Neck-pain-related disability and pain catastrophizing have an influence on the sensory-motor variables evaluated in patients with headache attributed to TMD.

The aims were to investigate the effects of anterior-posterior upper cervical mobilization (APUCM) on pain modulation in craniofacial and cervical regions and its influence on the sympathetic nervous system.Thirty-two patients with cervico-craniofacial pain of myofascial origin were randomly allocated into experimental or placebo groups. Each patient received 3 treatments. Outcome measures included bilateral pressure pain thresholds assessed at craniofacial and cervical points preintervention, after the second intervention and after the final treatment. Pain intensity and sympathetic nervous system variables (skin conductance, breathing rate, heart rate, and skin temperature) were assessed before and immediately after each intervention.The pressure pain thresholds in the craniofacial and cervical regions significantly increased (P0.001) and pain intensity significantly decreased (P0.001) in the treatment group compared with placebo. APUCM also produced a sympathoexcitatory response demonstrated by a significant increase in skin conductance, breathing rate, and heart rate (P0.001), but not in skin temperature (P=0.071), after application of the technique compared with placebo.This study provided preliminary evidence of a short-term hypoalgesic effect of APUCM on craniofacial and cervical regions of patients with cervico-craniofacial pain of myofascial origin, suggesting that APUCM may cause an immediate nociceptive modulation in the trigeminocervical complex. We also observed a sympathoexcitatory response, which could be related to the hypoalgesic effect induced by the technique, but this aspect should be confirmed in future studies.

This study evaluated the effects of Kaltenborn manual therapy on sensory and motor function in elderly patients with secondary carpometacarpal osteoarthritis (CMC OA). Twenty-nine female patients with secondary CMC OA (70-90 years old) were randomized into Kaltenborn manual therapy and sham groups. This study was designed as a double-blind, randomized controlled trial (RCT). Therapy consisted of Kaltenborn mobilization of posterior-anterior gliding with distraction in grade 3 of the carpometacarpal (CMC) joint of the dominant hand during 6 sessions over 2 weeks. Pain was measured by algometry, as the pressure pain threshold (PPT) at the CMC joint and tubercle of the scaphoid bone. The tip and tripod pinch strength was also measured. Grip strength was measured by a grip dynamometer. Measurements were taken before treatment and after 1 week (first follow-up [FU]) and 2 weeks (second FU). All values in the sham group remained unchanged during the treatment period. In the treated group, the PPT in the CMC joint was 2.98 ± 0.30 kg/cm(2), which increased after treatment to 4.07 ± 0.53, and was maintained at the same level during the first FU (3.46 ± 0.31) and second FU (3.84 ± 0.36). Similarly, the PPT in the scaphoid bone was 3.61 ± 0.29 kg/cm(2), which increased after treatment to 4.87 ± 0.37, and was maintained at the same level during the first FU (4.44 ± 0.43) and second FU (4.22 ± 0.32). In contrast, we found no differences in the tip, tripod pinch, and grip strength measurements between the treatment and sham groups. In conclusion, this study showed that Kaltenborn manual therapy decreased pain in the CMC joint and scaphoid bone areas of elderly female patients; however, it did not confer an increase in motor function in patients with CMC OA. 1.358 JCR (2011) Q3, 46/76 Health care sciences & services, 11/22 Integrative & complementary medicine, 34/62 Rehabilitation

The aim of this study was to investigate bilateral pressure-pain sensitivity over the trigeminal region, the cervical spine, and the tibialis anterior muscle in patients with mechanical chronic neck pain. Twenty-three patients with neck pain (56% women), aged 20 to 37 years old, and 23 matched controls (aged 20 to 38 years) were included. Pressure pain thresholds (PPTs) were bilaterally assessed over masseter, temporalis, and upper trapezius muscles, the C5-C6 zygapophyseal joint, and the tibialis anterior muscle in a blinded design. The results showed that PPT levels were significantly decreased bilaterally over the masseter, temporalis, and upper trapezius muscles, and also the C5-C6 zygapophyseal joint (P.001), but not over the tibialis anterior muscle (P = .4) in patients with mechanical chronic neck pain when compared to controls. The magnitude of PPT decreases was greater in the cervical region as compared to the trigeminal region (P.01). PPTs over the masseter muscles were negatively correlated to both duration of pain symptoms and neck-pain intensity (P.001). Our findings revealed pressure-pain hyperalgesia in the trigeminal region in patients with mechanical chronic neck pain, suggesting spreading of sensitization to the trigeminal region in this patient population.This article reveals the presence of bilateral pressure-pain hypersensitivity in the trigeminal region in patients with idiopathic neck pain, suggesting a sensitization process of the trigemino-cervical nucleus caudalis in this population. This finding has implications for development of management strategies.

We demonstrate the statistical integration of nuclear magnetic resonance (NMR) spectroscopy and capillary electrophoresis (CE) data in order to describe a pathological state caused by Schistosoma mansoni infection in a mouse model based on urinary metabolite profiles. Urine samples from mice 53 days post infection with S. mansoni and matched controls were analyzed via NMR spectroscopy and CE. The two sets of metabolic profiles were first processed and analyzed independently and were subsequently integrated using statistical correlation methods in order to facilitate cross assignment of metabolites. Using this approach, metabolites such as 3-ureidopropionate, p-cresol glucuronide, phenylacetylglycine, indoxyl sulfate, isocitrate, and trimethylamine were identified as differentiating between infected and control animals. These correlation analyses facilitated structural elucidation using the identification power of one technique to enhance and validate the other, but also highlighted the enhanced ability to detect functional correlations between metabolites, thereby providing potential for achieving deeper mechanistic insight into the biological process.

No studies have investigated the effects of the treatments directed at the cervical spine in patients with temporomandibular disorders (TMD). Our aim was to investigate the effects of joint mobilization and exercise directed at the cervical spine on pain intensity and pressure pain sensitivity in the muscles of mastication in patients with TMD. Nineteen patients (14 females), aged 19-57 years, with myofascial TMD were included. All patients received a total of 10 treatment session over a 5-week period (twice per week). Treatment included manual therapy techniques and exercise directed at the cervical spine. Outcome measures included bilateral pressure pain threshold (PPT) levels over the masseter and temporalis muscles, active pain-free mouth opening (mm) and pain (Visual Analogue Scale) and were all assessed pre-intervention, 48 h after the last treatment (post-intervention) and at 12-week follow-up period. Mixed-model anovas were used to examine the effects of the intervention on each outcome measure. Within-group effect sizes were calculated in order to assess clinical effect. The 2 x 3 mixed model anova revealed significant effect for time (F = 77.8; P0.001) but not for side (F = 0.2; P = 0.7) for changes in PPT over the masseter muscle and over the temporalis muscle (time: F = 66.8; P0.001; side: F = 0.07; P = 0.8). Post hoc revealed significant differences between pre-intervention and both post-intervention and follow-up periods (P0.001) but not between post-intervention and follow-up period (P = 0.9) for both muscles. Within-group effect sizes were large (d1.0) for both follow-up periods in both muscles. The anova found a significant effect for time (F = 78.6; P0.001) for changes in pain intensity and active pain-free mouth opening (F = 17.1; P0.001). Significant differences were found between pre-intervention and both post-intervention and follow-up periods (P0.001) but not between the post-intervention and follow-up period (P0.7). Within-group effect sizes were large (d0.8) for both post-intervention and follow-up periods. The application of treatment directed at the cervical spine may be beneficial in decreasing pain intensity, increasing PPTs over the masticatory muscles and an increasing pain-free mouth opening in patients with myofascial TMD.

Increasing rates of success in liver transplantation have increased the number of cases considered. However, liver post-transplant graft dysfunction of liver transplants (TXs) is not fully understood and by applying holistic approaches we can investigate metabolic change deriving from confounding factors such as liver fat content, ischaemia time, donor age, recipient's health, etc. Twenty-six hepatic bile samples taken from liver donors and recipients were retrieved from a total of six TXs, from these one recipient underwent post-graft dysfunction. CE was employed to fingerprint bile collected at 10 min increments in the donors and in the recipients. The electropherograms of these samples were aligned and normalised using correlation optimised warping algorithms and modelled with multivariate techniques. The resulting metabolic signatures were compared; in general donors and recipients showed distinct fingerprints and clustered separately. When a partial least square discriminant analysis (PLS-DA) model was constructed between donor and recipient's samples, a recipient of a 32 year old liver with normal steatosis, and shortest cold ischaemia time showed as the observation nearest to its donor observation, denoting minimal metabolic change. This study proposes CE fingerprinting of human bile as a promising technique to help unravel the complex metabolic pathways involved during transplantation.

Background: Orofacial pain, headaches, and neck pain are very common pain conditions in the general population and might be associated in their pathophysiology, although this is not yet clarified. The development and validation of a prediction inventory is important to minimize risks. Most recent questionnaires have not focused on pain, but pain is the common symptom in temporomandibular disorders, headaches, and neck pain. It is necessary to provide tools for these conditions. Objectives: The purpose of this study is to present the development and analysis of the factorial structure and psychometric properties of a new self-administered questionnaire (Craniofacial Pain and Disability Inventory [CF-PDI]) designed to measure pain, disability, and functional status of the mandibular and craniofacial regions. Study Design: Multicenter, prospective, cross-sectional, descriptive survey design. A secondary analysis of the reliability of the measures was a longitudinal, observational study. Setting: A convenience sample was recruited from a hospital and 2 specialty clinics in Madrid, Spain. Methods: The study sample consisted of 192 heterogeneous chronic craniofacial pain patients. A sub-sample of 106 patients was asked to answer the questionnaire a second time, to assess the test-retest reliability. The development and validation of the CF-PDI were conducted using the standard methodology, which included item development, cognitive debriefing, and psychometric validation. The questionnaire was assessed for the following psychometric properties: internal consistency (Cronbach’s α); floor and ceiling effects; testretest reliability (Intraclass Correlation Coefficient [ICC]; Bland and Altman method); construct validity (exploratory factor analysis); responsiveness (standard error of measurement [SEM] and minimal detectable change [MDC]); and convergent validity (Pearson correlation coefficient), by comparing visual analog scale (VAS), the Tampa Scale for Kinesiophobia (TSK-11), the Pain Catastrophizing Scale (PCS), the Neck Disability Index (NDI), and the Headache Impact Test-6 (HIT-6). Multiple linear regression analysis was used to estimate the strength of the associations with theoretically similar constructs. Results: The final version of the CF-PDI consists of 21 items. Exploratory factor analysis revealed 2 factors (“pain and disability” and “jaw functional status”), both with an eigenvalue greater than one, explaining 44.77% of the variance. Floor or ceiling effects were not observed. High internal consistency of the CF-PDI (Cronbach’s α: 0.88) and also of the 2 subscales (Cronbach’s α: 0.80 – 0.86) was confirmed. ICC was found to be 0.90 (95% confidence interval [CI] 0.86 – 0.93), which was considered to be excellent test-retest reliability. The SEM and MDC were 2.4 and 7 points, respectively. The total CF-PDI score showed a moderate correlation with most of the assessed questionnaires (r = 0.36 – 0.52) and a strong correlation with the NDI (r = 0.65; P < 0.001). The NDI, VAS, and TSK-11 were predictors of CF-PDI. Limitations: Only self-reported measures were considered for convergent validity. Future research should use physical tests to explore the clinical signs relating to pain and disability. Conclusion: The CF-PDI showed good psychometric properties. Based on the findings of this study, the CF-PDI can be used in research and clinical practice for the assessment of patients with craniofacial pain. Key words: Craniofacial pain, temporomandibular disorders, headache, neck pain, disability, development, questionnaire, reliability, psychometric validation, minimal detectable change