Contributo para a validação da versão portuguesa da Quebec Back Pain Disability Scale : fiabilidade e poder de resposta em utentes com dor lombar crónica

RESUMO: Um dos principais resultados das intervenções de Fisioterapia dirigidas a utentes com Dor Lombar Crónica (DLC) é reduzir a incapacidade funcional. A Quebec Back Pain Disability Scale (QBPDS) é um instrumento amplamente aceite a nível internacional na medição do nível de incapacidade funcional reportada pelos indivíduos com DLC. O objetivo deste estudo é dar um contributo para a adaptação cultural da versão portuguesa da QBPDS (QBPDS-VP) e investigar o poder de resposta e interpretabilidade da escala. Metodologia: Realizou-se um estudo metodológico, multicentro, baseado num coorte prospetivo de 132 utentes com DLC. Os utentes foram recrutados a partir da lista de espera de 16 serviços de Medicina Física e de Reabilitação/Fisioterapia de várias áreas geográficas de Portugal. A QBPDS- VP foi administrada 3 vezes, em 3 momentos de recolha de dados distintos: T0 - momento inicial (utentes em lista de espera); T1 - 1 semana de intervalo (início dos tratamentos de Fisioterapia); e T2 - 6 semanas de intervalo (pós-intervenção de Fisioterapia). Os dados recolhidos em T0 foram utilizados para a análise fatorial e para o estudo da consistência interna (n=132); os dados da amostra emparelhada de T0 e T1 (n=132) para a fiabilidade teste-reteste; e os dados da amostra emparelhada de T0 e T2 (n=120) para a análise do poder de resposta e interpretabilidade. A âncora externa utilizada foi a perceção global de mudança, neste caso a PGIC- VP, que foi respondida em T1 e T2. O nível de significância para o qual os valores se consideraram satisfatórios foi de p≤ 0,05. O tratamento dos dados foi realizado no software IBM SPSS Statistics (versão 20). Resultados: A QBPDS- VP é uma escala unidimensional, que revela uma excelente consistência interna (α de Cronbach= 0,95) e uma fiabilidade teste-reteste satisfatória (CCI= 0,696; IC 95%: 0,581–0,783). Esta escala demonstrou um poder de resposta moderado, quando aplicada em utentes com DLC ( = 0,426 e AAC= 0,741; IC 95%: 0,645 – 0,837). A Diferença Mínima Detetável (DMD) estimada foi de 19 pontos e as estimativas da Diferença Mínima Clinicamente Importante (DMCI) variaram entre 7 (pelo método curva ROC) e 8 pontos (pelo método “diferença média de pontuação”). A estimativa pela curva ROC deriva do ponto ótimo de corte de 6,5 pontos, com Área Abaixo da Curva (AAC)= 0,741, sensibilidade de 72%, e especificidade de 71%. Uma análise complementar da curva ROC baseada nas diferenças de pontuações da QBPDS, expressa em percentagem, revelou um ponto ótimo de corte de - 24% (AAC= 0,737, sensibilidade de 71%, e especificidade de 71%). Para pontuações iniciais da QBPDS- VP mais altas (≥34 pontos), foi encontrado um ponto ótimo de corte de 10,5 pontos (AAC= 0,738, sensibilidade de 73%, e especificidade de 67%). Conclusão: A QBPDS-VP demonstrou bons níveis de fiabilidade e poder de resposta, recomendando-se o seu uso na medição e avaliação da incapacidade funcional de utentes com DLC. A DMD estimada, de 19 pontos, determinou uma amplitude válida da QBPDS-VP de 19 a 81 pontos. Este estudo propõe estimativas de DMCI da QBPDS- VP numa aplicação específica da escala (em utentes com DLC que são referidos para a intervenção de Fisioterapia). A pontuação inicial da QBPDS- VP deve ser considerada na interpretação de mudanças de pontuação, após a intervenção de Fisioterapia.------------ ABSTRACT: One of the main results of physiotherapy interventions for patients with Chronic Low Back Pain (CLBP) is decrease the functional disability. The Quebec Back Pain Disability Scale (QBPDS) is an instrument widely accepted internationally, in measuring the level of disability reported by individuals with CLBP. The purpose of this study is to contribute to the cultural adaptation of the Portuguese version of QBPDS (QBPDS - PV) and investigate the Responsiveness and Interpretability of QBPDS-PV. Methodology: This was a methodological and multicenter study, based on a sample of 132 subjects with CLBP. The patients were recruited from the waiting lists of 16 medicine rehabilitation service, in many Portugal districts. The Quebec Back Pain Disability Scale was administered in three different moments: T0 – baseline (patients in the waiting list); T1- one week after T0 (the beginning of treatment); and T2 – six weeks after T1 (the posttreatment). The data collected at T0 were used for factor analysis and to study the internal consistency (n = 132); paired sample data of T0 and T1 (n=132) were used for test-retest reliability, and sample data paired for T0 and T2 (n=120) used for responsiveness and interpretability analysis. The external anchor was the global perception of change, measured by the Portuguese version of Patient’s Global Impression of Change (PGIC) Scale. The minimal level of significance established was p ≤ 0,05. Data analysis was performed using the IBM SPSS Statistics software (version 20). Results: The QBPDS-PV is a unidimensional scale, demonstrates an excellent internal consistency (Cronbach's α=0.95) and satisfactory test-retest reliability (ICC= 0.696, 95% CI: 0.581–0.783). The scale revealed moderate responsiveness when applied to patients with CLBP ( = 0.426 and AUC= 0.741, 95% CI: 0.645 - 0.837). The Smallest Detectable Change (SDC) was 19 points, whereas the Minimal Clinically Important Change (MCIC) ranged between 7 (ROC curve method) and 8 points (by the "mean difference score"). The estimate was derived from the ROC curve by an optimal cutoff point of 6.5 points, with Area Under the Curve (AUC)= 0.741, sensitivity 72%, and specificity of 71%. A complementary analysis of the ROC curve based on differences in QBPDS scores from baseline, expressed in percentage, revealed an optimal cutoff point of -24% (AUC= 0.737, sensitivity of 71%, and specificity of 71%). For the highest initial scores of QBPDS-PV (≥ 34 points) was found an optimal cutoff of 10.5 points (AUC= 0.738, sensitivity of 73%, and specificity 67%). Conclusion: The QBPDS-PV demonstrated good levels of reliability and responsiveness, being recommended its use in the measurement and evaluation of disability of patients with CLBP. The SDC of 19 points determined the QBPDS‟ scale width of 19 to 81. This study proposes MCIC values for QBPDS –PV for this specific setting (in CLBP patients who are referred for physiotherapy intervention). The QBPDS –PV baseline score have to be taken into account while interpreting the score change after physiotherapy intervention.

Degree of disability, pain levels, muscle strength, and electromyographic function in patients with Hansen's disease with common peroneal nerve damage

INTRODUCTION: This study evaluated the degree of disability, pain levels, muscle strength, and electromyographic function (RMS) in individuals with leprosy. METHODS: We assessed 29 individuals with leprosy showing common peroneal nerve damage and grade 1 or 2 disability who were referred for physiotherapeutic treatment, as well as a control group of 19 healthy participants without leprosy. All subjects underwent analyses of degree of disability, electromyographic tests, voluntary muscle force, and the Visual Analog Pain Scale. RESULTS: McNemar's test found higher levels of grade 2 of disability (Δ = 75.9%; p = 0.0001) among individuals with leprosy. The Mann-Whitney test showed greater pain levels (Δ = 5.0; p = 0.0001) in patients with leprosy who had less extension strength in the right and left extensor hallucis longus muscles (Δ = 1.28, p = 0.0001; Δ = 1.55, p = 0.0001, respectively) and dorsiflexion of the right and left feet (Δ = 1.24, p = 0.0001; Δ = 1.45, p = 0.0001, respectively) than control subjects. The Kruskal-Wallis test showed that the RMS score for dorsiflexion of the right (Δ = 181.66 m·s-2, p = 0.001) and left (Δ = 102.57m·s-2, p = 0.002) feet was lower in patients with leprosy than in control subjects, but intragroup comparisons showed no difference. CONCLUSIONS: Leprosy had a negative influence on all of the study variables, indicating the need for immediate physiotherapeutic intervention in individuals with leprosy. This investigation opens perspectives for future studies that analyze leprosy treatment with physical therapeutic intervention.

Appropriateness criteria for surgery improve clinical outcomes in patients with low back pain and/or sciatica.

STUDY DESIGN: Prospective, controlled, observational outcome study using clinical, radiographic, and patient/physician-based questionnaire data, with patient outcomes at 12 months follow-up. OBJECTIVE: To validate appropriateness criteria for low back surgery. SUMMARY OF BACKGROUND DATA: Most surgical treatment failures are attributed to poor patient selection, but no widely accepted consensus exists on detailed indications for appropriate surgery. METHODS: Appropriateness criteria for low back surgery have been developed by a multispecialty panel using the RAND appropriateness method. Based on panel criteria, a prospective study compared outcomes of patients appropriately and inappropriately treated at a single institution with 12 months follow-up assessment. Included were patients with low back pain and/or sciatica referred to the neurosurgical department. Information about symptoms, neurologic signs, the health-related quality of life (SF-36), disability status (Roland-Morris), and pain intensity (VAS) was assessed at baseline, at 6 months, and at 12 months follow-up. The appropriateness criteria were administered prospectively to each clinical situation and outside of the clinical setting, with the surgeon and patients blinded to the results of the panel decision. The patients were further stratified into 2 groups: appropriate treatment group (ATG) and inappropriate treatment group (ITG). RESULTS: Overall, 398 patients completed all forms at 12 months. Treatment was considered appropriate for 365 participants and inappropriate for 33 participants. The mean improvement in the SF-36 physical component score at 12 months was significantly higher in the ATG (mean: 12.3 points) than in the ITG (mean: 6.8 points) (P = 0.01), as well as the mean improvement in the SF-36 mental component score (ATG mean: 5.0 points; ITG mean: -0.5 points) (P = 0.02). Improvement was also significantly higher in the ATG for the mean VAS back pain (ATG mean: 2.3 points; ITG mean: 0.8 points; P = 0.02) and Roland-Morris disability score (ATG mean: 7.7 points; ITG mean: 4.2 points; P = 0.004). The ATG also had a higher improvement in mean VAS for sciatica (4.0 points) than the ITG (2.8 points), but the difference was not significant (P = 0.08). The SF-36 General Health score declined in both groups after 12 months, however, the decline was worse in the ITG (mean decline: 8.2 points) than in the ATG (mean decline: 1.2 points) (P = 0.04). Overall, in comparison to ITG patients, ATG patients had significantly higher improvement at 12 months, both statistically and clinically. CONCLUSION: In comparison to previously reported literature, our study is the first to assess the utility of appropriateness criteria for low back surgery at 1-year follow-up with multiple outcome dimensions. Our results confirm the hypothesis that application of appropriateness criteria can significantly improve patient outcomes.

Once-yearly zoledronic acid and days of disability, bed rest, and back pain: randomized, controlled HORIZON Pivotal Fracture Trial.

The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) = 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR = 0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the number of days that patients reported back pain, limited activity owing to back pain, and limited activity and bed rest owing to a fracture.

Rapid Improvement In Health-Related Quality Of Life In Gouty Arthritis Patients Treated With Canakinumab (Acz885) Compared To Triamcinolone Acetonide

Background : Canakinumab, a fully human anti-IL-1b antibody has been shown to control inflammation in gouty arthritis. This study evaluated changes in health-related quality of life (HRQoL) in patients treated with canakinumab or triamcinolone acetonide (TA).Methods : An 8-wk, dose-ranging, active controlled, single-blind study in patients (_18 to _80 years) with acute gouty arthritis flare, refractory to or contraindicated to NSAlDs and/or colchicine, were randomized to canakinumab 10, 25, 50, 90, 150mg sc or TA 40mg im. HRQoL was assessed using patient reported outcomes evaluating PCS and MCS, and subscale scores of SF-36_ [acute version 2]) and functional disability (HAQ-DI_).Results : In canakinumab 150mg group, the most severe impairment at baseline was reported for physical functioning and bodily pain; levels of 41.5 and 36.0, respectively, which improved in 7 days to 80.0 and 72.2 (mean increases of 39.0 and 35.6) and at 8 wks improved to 86.1 and 86.6 (mean increases of 44.6 and 50.6); these were higher than levels seen in the general US population. TA group, showed less improvement in 7 days (mean increases of 23.3 and 21.3 for physical function and bodily pain). Functional disability scores, measured by the HAQ-DI_ decreased in both treatment groups (Table 1).Conclusions : Gouty arthritis patients treated with canakinumab showed a rapid improvement in physical and mental well-being based on SF-36_ scores. In contrast to the TA group, patients treated with canakinumab showed improvement in 7 days in physical function and bodily pain approaching levels of the general population.Disclosure statement : U.A., A.F., V.M., D.R., P.S. and K.S. are employees and shareholders of Novartis Pharma AG. A.P. has received research support from Novartis Pharma AG. N.S. has received research support and consultancy fees from Novartis Pharmaceuticals Corporation, has served on advisory boards for Novartis, Takeda, Savient, URL Pharma and EnzymeRx, and is/has been a member of a speakers' bureau for Takeda. A.S. has received consultation fees from Novartis Pharma AG, Abbott, Bristol-Myers Squibb, Essex, Pfizer, MSD, Roche, UCB and Wyeth. All other authors have declared no conflicts of interest.

One-year prevalence of low back pain in two Swiss regions: estimates from the population participating in the 1992-1993 MONICA project.

STUDY DESIGN: A cross-sectional survey was performed. OBJECTIVE: To estimate the extent of low back pain as a public health problem. SUMMARY OF BACKGROUND DATA: Health surveys converge on very high estimates of low back pain in general populations, but few studies have included severity criteria in their definition and conclusions. Because it is unlikely that interventions will influence the prevalence of minimal and infrequent symptoms, greater attention should be paid to characteristics of low back pain that indicate some impact on the life of survey respondents. METHODS: Two regions participated in the MONICA (MONitoring of trends and determinants in CArdiovascular disease) project in Switzerland. Participants randomly selected from the general population completed a standard self-administered questionnaire on cardiovascular risk factors. A special section on low back pain was added in the third (1992-1993) MONICA survey and completed by 3227 participants. RESULTS: A regional difference found in the 12-month prevalence rate disappeared with the inclusion of severity criteria. Low back pain over more than seven cumulated days was reported among men by 20.2% (age range, 25-34 years) to 28.5% (age range, 65-74 years), respectively, among women by 31.1% to 38.5%. Similar rates of reduction in activity (professional, housekeeping, and leisure time) and medical consultation (conventional and nonconventional) motivated by low back pain characterized the two participating regions. The cumulative duration of pain was related to all the indicators showing the impact of low back pain on everyday life. CONCLUSIONS: Determining the cumulative duration of low back pain over the preceding year is a straightforward task, and a cutoff at 1 week seems appropriate for distinguishing between low- and high-impact low back pain.

Rapid Improvement in Health-Related Quality of Life (HRQoL) in Gouty Arthritis Patients Treated with Canakinumab (ACZ885) Compared to Triamcinolone Acetonide

Background: Gouty arthritis is a painful inflammatory disease with a significant impact on patients' HRQoL. In gouty arthritis, the inflammatory response is initiated by interleukin-1b (IL-1b) release, due to activation of the NALP3 inflammasome by MSU crystals. Canakinumab, a fully human anti-IL-1b antibody has a long half-life and has been shown to control inflammation in gouty arthritis. This study evaluated changes in HRQoL in gouty arthritis patients following treatment with canakinumab or triamcinolone acetonide (TA).Methods: This was an 8-week, dose-ranging, multi-center, active controlled, single-blind study. Patients (>=18 to <=80 years) experiencing an acute gouty arthritis flare, refractory to or contraindicated to NSAlDs and/or colchicine, were randomized to canakinumab 10, 25, 50, 90, 150 mg sc or TA 40 mg im. HRQoL was assessed as an exploratory endpoint at baseline and different pre-specified time-points using patient reported outcomes evaluating general mental and physical component summary scores and subscale scores of SF-36® (acute version 2) and functional disability (HAQ-DI©). We report HRQoL results for canakinumab 150 mg, the dose that was selected for the Phase III studies.Results: Baseline assessments showed a major impact on the HRQoL during acute gouty arthritis. Compared to TA, canakinumab 150 mg showed greater improvements in SF-36® physical and mental component summary and subscale scores at 7 days post-dose.In the canakinumab 150 mg group, the most severe impairment at baseline was reported for physical functioning and bodily pain; levels of 41.5 and 36.0, respectively, which improved within 7 days to 80.0 and 72.2 (mean increases of 39.0 and 35.6) approaching levels of the general US population (84.2 and 75.2). 8 weeks post-dose patients reached levels of 86.1 and 86.6 (mean increases of 44.6 and 50.6 for physical functioning and bodily pain, respectively) and these were higher than levels seen in the general US population. This was in contrast to patients treated with TA, who showed less improvement within 7 days (mean increases of 23.3 and 21.3 for physical function and bodily pain, respectively). None of the scores reached levels of the general US population 8 weeks post-dose. Functional disability scores, as measured by the HAQ-DI© decreased in both treatment groupsConclusions: All canakinumab doses showed a rapid improvement in physical and mental well-being of gouty arthritis patients based on SF-36® scores, in particular the 150 mg dose. In contrast to the TA group, patients treated with canakinumab showed improvement within 7 days in physical function and bodily pain approaching levels of the general population. The 150 mg dose of canakinumab was selected for further development in Phase III studies.

Family burden related to clinical and functional variables of people with intellectual disability with and without a mental disorder

Few studies have been found that to assess the factors that explain higher levels of familyburden in adults with intellectualdisability (ID) and intellectualdisability and mental disorders (ID-MD). The aims of this study were to assess familyburden in people with ID and ID-MD and to determine which sociodemographic, clinical and functionaldisabilityvariables account for familyburden. The sample is composed of pairs of 203 participants with disability and their caregivers, of which 33.5% are caregivers of people with ID and 66.5% of ID-MD. Assessments were performed using scales of clinical and functionaldisability as the following instruments: Weschler Adult Intelligence Scale-III (WAIS-III), Inventory for Client and Agency Planning (ICAP), Psychiatric Assessment Schedule for Adults with Development Disability (PAS-ADD checklist), Disability Assessment Schedule of the World Health Organization (WHO-DAS-II) and familyburden (Subjective and Objective FamilyBurden Inventory - SOFBI/ECFOS-II). People with ID-MD presented higher levels of functionaldisability than those with ID only. Higher levels of familyburden were related to higher functionaldisability in all the areas (p < 0.006-0.001), lower intelligence quotient (p < 0.001), diagnosis of ID-MD (p < 0.001) and presence of organic, affective, psychotic and behavioral disorders (p < 0.001). Stepwise multiple regression showed that behavioral problems, affective and psychotic disorder, disability in participation in society, disability in personal care and presence of ID-MD explained more than 61% of the variance in familyburden. An integrated approach using effective multidimensional interventions is essential for both people with ID and ID-MD and their caregivers in order to reduce familyburden.

Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis.

OBJECTIVE: To assess health-related quality of life (HRQOL) in abatacept-treated children/adolescents with juvenile idiopathic arthritis (JIA). METHODS: In this phase III, double-blind, placebo-controlled trial, subjects with active polyarticular course JIA and an inadequate response/intolerance to ≥1 disease-modifying antirheumatic drug (including biologics) received abatacept 10 mg/kg plus methotrexate (MTX) during the 4-month open-label period (period A). Subjects achieving the American College of Rheumatology Pediatric 30 criteria for improvement (defined "responders") were randomized to abatacept or placebo (plus MTX) in the 6-month double-blind withdrawal period (period B). HRQOL assessments included 15 Child Health Questionnaire (CHQ) health concepts plus the physical (PhS) and psychosocial summary scores (PsS), pain (100-mm visual analog scale), the Children's Sleep Habits Questionnaire, and a daily activity participation questionnaire. RESULTS: A total of 190 subjects from period A and 122 from period B were eligible for analysis. In period A, there were substantial improvements across all of the CHQ domains (greatest improvement was in pain/discomfort) and the PhS (8.3 units) and PsS (4.3 units) with abatacept. At the end of period B, abatacept-treated subjects had greater improvements versus placebo in all domains (except behavior) and both summary scores. Similar improvement patterns were seen with pain and sleep. For participation in daily activities, an additional 2.6 school days/month and 2.3 parents' usual activity days/month were gained in period A responders with abatacept, and further gains were made in period B (1.9 versus 0.9 [P = 0.033] and 0.2 versus -1.3 [P = 0.109] school days/month and parents' usual activity days/month, respectively, in abatacept- versus placebo-treated subjects). CONCLUSION: Improvements in HRQOL were observed with abatacept, providing real-life tangible benefits to children with JIA and their parents/caregivers.

Pain-related diseases and sleep disorders

Pain and sleep share mutual relations under the influence of cognitive and neuroendocrine changes. Sleep is an important homeostatic feature and, when impaired, contributes to the development or worsening of pain-related diseases. The aim of the present review is to provide a panoramic view for the generalist physician on sleep disorders that occur in pain-related diseases within the field of Internal Medicine, such as rheumatic diseases, acute coronary syndrome, digestive diseases, cancer, and headache.

Reduction of blood nitric oxide levels is associated with clinical improvement of the chronic pelvic pain related to endometriosis

The objective of this prospective study was to determine the plasma levels of nitric oxide (NO) in women with chronic pelvic pain secondary to endometriosis (n=24) and abdominal myofascial pain syndrome (n=16). NO levels were measured in plasma collected before and 1 month after treatment. Pretreatment NO levels (μM) were lower in healthy volunteers (47.0±12.7) than in women with myofascial pain (64.2±5.0, P=0.01) or endometriosis (99.5±12.9, P<0.0001). After treatment, plasma NO levels were reduced only in the endometriosis group (99.5±12.9 vs 61.6±5.9, P=0.002). A correlation between reduction of pain intensity and reduction of NO level was observed in the endometriosis group [correlation = 0.67 (95%CI = 0.35 to 0.85), P<0.0001]. Reduction of NO levels was associated with an increase of pain threshold in this group [correlation = -0.53 (-0.78 to -0.14), P<0.0001]. NO levels appeared elevated in women with chronic pelvic pain diagnosed as secondary to endometriosis, and were directly associated with reduction in pain intensity and increase in pain threshold after treatment. Further studies are needed to investigate the role of NO in the pathophysiology of pain in women with endometriosis and its eventual association with central sensitization.

Conductas de dolor y discapacidad en migra??as y cefaleas tensionales : adaptaci??n espa??ola del Pain Behavior Questionaire (PBQ) y del Headache Disability Inventory (HDI)

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