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Objective: To assess the benefits and harms associated with biopsychosocial rehabilitation in patients with inflammatory arthritis and osteoarthritis (OA). Methods: We performed a systematic review and meta-analysis. Data were collected through electronic searches of Cochrane CENTRAL, MEDLINE, Embase, PsycInfo, and CINAHL databases up to March 2019. Trials examining the effect of biopsychosocial rehabilitation in adults with inflammatory arthritis and/or OA were considered eligible, excluding rehabilitation adjunct to surgery. The primary outcome for benefit was pain and total withdrawals for harm. Results: Of the 27 trials meeting the eligibility criteria, 22 trials (3,750 participants) reported sufficient data to be included in the quantitative synthesis. For patient-reported outcome measures, biopsychosocial rehabilitation was slightly superior to control for pain relief (standardized mean difference [SMD] −0.19 [95% confidence interval (95% CI) −0.31, –0.07]), had a small effect on patient global assessment score (SMD –0.13 [95% CI –0.26, –0.00]), with no apparent effect on health-related quality of life, fatigue, self-reported disability/physical function, mental well-being, and reduction in pain intensity ≥30%. Clinician-measured outcomes displayed a small effect on observed disability/physical function (SMD −0.34 [95% CI −0.57, −0.10]), a large effect on physician global assessment score (SMD −0.72 [95% CI −1.18, −0.26]), and no effect on inflammation. No difference in harms existed in terms of the number of withdrawals, adverse events, or serious adverse events. Conclusion: Biopsychosocial rehabilitation produces a significant but clinically small beneficial effect on patient-reported pain among patients with inflammatory arthritis and OA, with no difference in harm. Methodologic weaknesses were observed in the included trials, suggesting low-to-moderate confidence in the estimates of effect.

Covariate adjustment is often used in statistical analysis of randomized experiments to increase efficiency of estimators of treatment effects. In this paper, we study covariate adjustment based on the empirical and Euclidean likelihoods, and propose weighted versions that arise as natural alternatives. The weighted methods incorporate the auxiliary information that the covariates have equal means among the treatment groups due to randomization. We show that the empirical and the Euclidean likelihoods and their weighted versions are first order equivalent to Koch’s nonparametric covariance adjustment. Allowing the weights to be negative, the resulting pseudo Euclidean likelihood is equivalent to Koch’s method, and its weighted version can be viewed as a weighted version of Koch’s method. In a simulation study, we assess the finite sample properties of the proposed methods. The analysis of a clinical trial data set illustrates an application of these methods to a practical situation.

Objectives To explore the prognostic value of pre-specified comorbidities on treatment outcomes in PsA, and to compare baseline data with cutaneous psoriasis without arthritis and healthy controls (HC). Methods Patients initiating conventional synthetic/biological disease-modifying antirheumatic drugs were enrolled in this clinical observational cohort study, and data on comorbidities, and clinical and patient-reported outcomes were retrieved at baseline and after 4 months. Pearson’s chi-squared tests were performed to investigate the prognostic value of pre-specified comorbidities and achievement of ACR20, DAPSA50 and MDA. Mann–Whitney U tests were used to compare OMERACT PsA Core Outcome Set (COS) measures at baseline and follow-up for the pre-specified comorbidities. Results A total of 100 PsA patients were included at baseline. Statistically significantly fewer patients with obesity achieved DAPSA50 compared with patients without obesity (P =0.035), and fewer patients with hypertension (P =0.034) and Charlson Comorbidity Index (CCI) ≥1 (P =0.027), respectively, achieved MDA compared with patients without these comorbidities. Patients with obesity, hypertension, widespread pain, and CCI ≥1 had significantly worse COS measures at follow-up compared with patients without these comorbidities. At baseline, patients with PsA had higher disease burden compared with patients with cutaneous psoriasis and HC, including higher pain (P Conclusion Obesity, hypertension and CCI ≥1 were prognostic factors for poorer treatment outcome rates in PsA. Pain and fatigue were more frequently reported among patients with PsA compared with patients with cutaneous psoriasis and HC. Trial registration The Danish National Committee on Health Research Ethics: H-15009080; Data Protection Agency: 2012-58-0004; ClinicalTrials.gov: NCT02572700.

OBJECTIVE: To study the prognostic value of widespread pain and of musculoskeletal ultrasound (US) examination for subsequent treatment outcomes in patients with psoriatic arthritis (PsA).METHODS: An exploratory prospective cohort study enrolled patients with PsA initiating biologic or conventional synthetic disease-modifying antirheumatic drugs in routine care. Clinical, US, and patient-reported measures were collected at baseline and after 4 months. Widespread nonarthritic pain (WP) was defined as a Widespread Pain Index score of ≥4 with pain in ≥4 of 5 regions. PsA activity by US was defined as color Doppler (yes/no) in selected entheses, joints, or tendons. The main response criteria included the American College of Rheumatology 20% improvement, the Disease Activity in Psoriatic Arthritis 50% improvement, and minimal disease activity. The primary analyses were age- and sex-adjusted logistic regression.RESULTS: WP was present in 24 of 69 included patients (35%) and was associated with worse patient-reported and composite baseline measures, while US and other objective findings were similar to those in patients without WP. The odds of reaching minimal disease activity after 4 months were significantly greater for patients enrolled without WP (odds ratio 18.43 [95% confidence interval 1.51, 224.41]; P = 0.022), while WP did not impair other response measures. Patients with baseline color Doppler activity (n = 42 [61%]) had a worse objective PsA burden, but their chance of treatment response was comparable to those without color Doppler.CONCLUSION: More than one-third of patients with PsA presented with WP, which was associated with worse patient-reported scores and failure to achieve minimal disease activity following conventional synthetic or biologic disease-modifying antirheumatic drug therapy. PsA activity by color Doppler US had no influence on subsequent treatment response in this PsA cohort.

Background Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia. Methods A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18–64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers. Discussion This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia. Trial registration EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020

Objective This study explores dose–response relationships when treating fibromyalgia with low-dose naltrexone. Design A single-blinded clinical trial was carried out using the “up-and-down” method. Subjects Subjects included women with a diagnosis of fibromyalgia aged 18–60 years who had been referred to treatment at a public pain clinic at a Danish university hospital. Methods The test doses were in the range 0.75–6 mg, and the dosing interval was 0.75 mg. The method was sequential and allowed predicting the dose effective in 50% (ED50) and 95% (ED95) of the subjects when the dose had shifted direction 10 times, and six pairs of “up-and-down” data were available. Results A total of 27 subjects were included in the study; two subjects were withdrawn. After inclusion of 25 evaluable subjects, the dose estimates were calculated as 3.88 mg for ED50 and 5.40 mg for ED95. As a secondary outcome, the effects on 10 common fibromyalgia symptoms were evaluated. A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone. Conclusions This study is the first to explore dose–response relationships in the treatment of fibromyalgia with low-dose naltrexone. Future placebo-controlled randomized clinical trials are needed, and according to our findings, 4.5 mg, which has previously been used, seems to be a relevant test dose. We recommend that future studies include additional nonpain fibromyalgia symptoms as outcome measures.

Research into the neurobiological and psychosocial mechanisms involved in fibromyalgia (FM) has progressed remarkably in recent years. Despite this, currents accounts of FM fail to capture the complex, dynamic and mutual crosstalk between neurophysiological and psychosocial domains. We conducted a comprehensive review of the existing literature in order to synthesise current knowledge on FM, explore and highlight multi-level links and pathways among different systems and build bridges between existing approaches. An extensive panel of international experts in neurophysiology and psychosocial aspects of FM discussed the collected evidence and progressively refined and conceptualized its interpretation. Fibromyalgia is a complex condition resulting from the dynamic interplay between multiple systems and processes. We provided an updated overview of the most relevant observations in FM to date as well as the potential pathways by which they exert they are related and exert their mutual influence, to produce the manifestations commonly associated with FM. This review constituted the first step towards and supported the development of a much needed model capable of integrating the main factors implicated in FM into a single, unified model that may prove valuable in understanding and managing FM.

Objective.Fatigue is one of the most significant symptoms, and an outcome of great importance, in patients with psoriatic arthritis (PsA), but associations between underlying components of fatigue experienced by patients in relation to the disease have been sparsely investigated. The objectives were to describe the degree of fatigue in patients with PsA, and to examine important components associated with fatigue.Methods.We performed a cross-sectional survey including patients registered in the Danish nationwide registry DANBIO from December 2013 to June 2014. Principal component analysis (PCA) was used to identify factors associated with fatigue.Results.A total of 1062 patients with PsA were included in the study. A PCA reduced co-variables into 3 components explaining 63% of fatigue in patients. The first component, contributing to 31% of fatigue, was composed of inflammatory factors including swollen and tender joints, physician’s global assessment, elevated C-reactive protein (CRP), and high Pain Detect Questionnaire (PDQ) score. The second component, contributing to 17% of fatigue, consisted of increasing age and long disease duration. The third component, contributing to 15% of fatigue, consisted of high PDQ score, tender joint count, increasing age, and concomitant low CRP, suggestive of a chronic pain component consisting of central pain sensitization or structural joint damage.Conclusion.Fatigue in patients with PsA may be driven by clinical inflammatory factors, disease duration, and chronic pain in the absence of inflammation.

Introduction: The association between chronic widespread pain (CWP) and disability is well established. Although research support large interindividual differences in functional outcomes, limited studies are available on the socio-economic consequences of offering stratified treatment based on prognostic factors. Identification of predictors of long-term functional outcomes such as work disability as a critical consequence, could assist early and targeted personalised interventions. The primary objective of this cohort study is to identify prognostic factors for the primary endpoint work status (employed and working vs not working) in patients with CWP assessed 3 years from baseline, that is, at referral for specialist care.Methods and analyses: Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. The first 1000 patients ≥18 years of age registered in a clinical research database (DANFIB registry) with CWP either ‘employed and working’ or ‘not working’ will be enrolled. Participants must meet the American College of Rheumatology 1990 definition of CWP, that is, pain in all four body quadrants and axially for more than 3 months and are additionally screened for fulfilment of criteria for fibromyalgia. Clinical data and patient-reported outcomes are collected at referral (baseline) through clinical assessment and electronic questionnaires. Data on the primary endpoint work status at baseline and 3 years from baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and the nationwide Danish DREAM database. Prognostic factor analysis will be based on multivariable logistic regression modelling with the dichotomous work status as dependent variable.Ethics and dissemination: Sensitive personal data will be anonymised according to regulations by the Danish Data Protection Agency, and informed consent are obtained from all participants. Understanding and improving the prognosis of a health condition like CWP should be a priority in clinical research and practice. Results will be published in international peer-reviewed journals. Introduction The association between chronic widespread pain (CWP) and disability is well established. Although research support large interindividual differences in functional outcomes, limited studies are available on the socio-economic consequences of offering stratified treatment based on prognostic factors. Identification of predictors of long-term functional outcomes such as work disability as a critical consequence, could assist early and targeted personalised interventions. The primary objective of this cohort study is to identify prognostic factors for the primary endpoint work status (employed and working vs not working) in patients with CWP assessed 3 years from baseline, that is, at referral for specialist care. Methods and analyses Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. The first 1000 patients ≥18 years of age registered in a clinical research database (DANFIB registry) with CWP either employed and working' or not working' will be enrolled. Participants must meet the American College of Rheumatology 1990 definition of CWP, that is, pain in all four body quadrants and axially for more than 3 months and are additionally screened for fulfilment of criteria for fibromyalgia. Clinical data and patient-reported outcomes are collected at referral (baseline) through clinical assessment and electronic questionnaires. Data on the primary endpoint work status at baseline and 3 years from baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and the nationwide Danish DREAM database. Prognostic factor analysis will be based on multivariable logistic regression modelling with the dichotomous work status as dependent variable. Ethics and dissemination Sensitive personal data will be anonymised according to regulations by the Danish Data Protection Agency, and informed consent are obtained from all participants. Understanding and improving the prognosis of a health condition like CWP should be a priority in clinical research and practice. Results will be published in international peer-reviewed journals. Trial registration number NCT04862520.

Introduction:. Survivors of torture are for many reasons at particularly high risk for inadequate assessment and management of pain. Among the many health problems associated with torture, persistent pain is frequent, particularly pain in the musculoskeletal system. The pathophysiology underlying post-torture pain is largely unknown, but pain inflicted in torture may have profound effects on neurophysiology and pain processing. Methods:. A narrative review of assessment and treatment studies, informed by clinical experience, was undertaken. Results:. The clinical presentation in survivors of torture shares characteristics with other chronic primary pain syndromes, including chronic widespread pain. Unfortunately, such pain is often misunderstood and dismissed as a manifestation of psychological distress, both in specialist psychosocially oriented torture services and in mainstream health care. This means that pain is at risk of not being recognized, assessed, or managed as a problem in its own right. Conclusions:. The available research literature on rehabilitation for torture survivors is predominantly targeted at mental health problems, and studies of effectiveness of pain management in torture survivors are lacking. Rehabilitation is identified as a right in the UN Convention on Torture, aiming to restore as far as possible torture survivors' health and capacity for full participation in society. It is therefore important that pain and its consequences are adequately addressed in rehabilitative efforts. This article summarizes the current status on assessment and management of pain problems in the torture survivor.

Background Pain is a major concern for patients with psoriatic arthritis (PsA) in spite of treatment with biologic/conventional disease modifying drugs (b/csDMARDS). Studies on the prognostic role of pain mechanisms in PsA, are scarce. Objectives To investigate the presence of widespread non-arthritic pain (WP) in patients with PsA, and determine its relation to patient-reported, clinical- and ultrasound (US) disease measures, as well as to achievement of 4 months response to b/csDMARD therapy. Secondly, to study if US Colour Doppler activity (CD) at baseline is associated to treatment response. Methods A prospective cohort study was performed following a protocol.1Patients initiating b/csDMARDs for PsA were recruited from rheumatology clinics in Copenhagen. Clinical- and US examinations and patient-reported outcomes (PROs) were performed at baseline and after 4 months. WP was defined as a Widespread Pain Index≥4, and pain in ≥4/5 regions. CD activity in selected joints, entheses and tendons (73 projections) was summed. Response was assessed by American College of Rheumatology 20% (ACR20), Disease Activity in Psoriatic Arthritis 50% (DAPSA 50) and Minimal Disease Activity (MDA). Main response analyses were based on intention to treat with non-responder imputation, and consisted of logistic regressions adjusting for gender and age. Results Of 123 screened patients, 69 were included. Of these, 24 (35%) fulfilled the WP definition. At baseline (Table), WP was associated with worse PROs and composite scores, while CD activity and clinical measures were similar to those without WP. WP profile was significantly related to achievement of MDA at follow-up but not to other response criteria (table 1). Presence of CD activity at baseline was not significantly associated to 4 months response by any criteria, e.g. 19%/31% with CD=0/CD >0, reached ACR20, (p=0.262). Conclusions WP was present in 1/3 of patients, and associated with worse PROs, composite measures, and failure to achieve MDA at follow-up. Neither WP nor CD at baseline was related to other response measures. Reference Hojgaardet al. BMJ Open2006;6. doi:10.1136/bmjopen-2015-010650 Acknowledgements Thanks to: The Oak foundation, Danish Rheumatism Association, Centre for Rheumatology Gentofte Hospital. Disclosure of Interest None declared

Background Evidence is emerging that pain in rheumatoid arthritis (RA) exists without underlying inflammation. Our objective was to evaluate the prognostic value of pain classification at treatment initiation using the painDETECT questionnaire (PDQ). Outcomes were change in DAS28-CRP and RAMRIS synovitis score. Methods RA patients initiating a disease-modifying anti-rheumatic drug (DMARD) or initiating/ switching a biological agent were included. Follow-up time was 4 months. Clinical examination, imaging (MRI, dynamic contrast-enhanced MRI (DCE-MRI)), and patient-reported outcomes were undertaken. The PDQ was used to differentiate pain mechanisms. Mean change (95% CI) was calculated using ANCOVA. Multivariable regression models were used to determine a prognostic value. Results A total of 102 patients were included; 75 were enrolled for MRI. Mean changes in baseline variables were greatest in the high PDQ classification group (> 18), while limited in the intermediate group (13–18). The 12 patients with high baseline PDQ score all changed pain classification group. No prognostic value of PDQ pain classification was found in relation to change of DAS28-CRP, RAMRIS score, or VAS pain. In the unadjusted model, RAMRIS score at baseline was associated with change in DAS28-CRP. The exploratory variables of DCE-MRI did not differ from other inflammatory variables. Conclusions In RA patients a high PDQ score (non-nociceptive pain) at baseline was not associated with worse outcomes, in fact these patients had numerically greater improvement in DAS28-CRP. However, pain classification by PDQ was not independently associated with change in DAS28-CRP, RAMRIS score, or VAS pain in the prognostic models. Furthermore, patients classified with a high baseline PDQ score changed pain classification group. Patients with unclear pain mechanism had reduced numerically treatment response. Trial registration The study was approved by the Regional Ethics Committee of the Capital of Denmark April 18 2013; identification number H-3-2013-049. Electronic supplementary material The online version of this article (10.1186/s13075-018-1581-4) contains supplementary material, which is available to authorized users.

Background: Assessment of depression in chronic pain patients by self-rating questionnaires developed and validated for use in normal and/or psychiatric populations is common. The aim of this study was to evaluate the psychometric properties of the Major Depression Inventory (MDI) in a sample of females with chronic widespread pain (CWP).Method: A total of 263 females diagnosed with CWP and referred for rehabilitation completed the MDI as part of the baseline evaluation. Rasch analysis was applied to this dataset. Rasch measurement models allow detailed analyses of an instruments rating scale and further aspects of validity, including fit of individual scale items to a unidimensional model indicating assessment of a single construct (depression), as a prerequisite for measurement.Results: The Rasch analysis revealed substantial problems with the rating scale properties of the MDI and lack of unidimensionality. In contrast to somatic items, MDI items related to depressed mood and negative view of oneself were distributed at the higher end of the item difficulty measurement scale, indicating low endorsement of these items.Discussion: From the perspective of the Rasch measurement model, the MDI demonstrated insufficient psychometric properties when used to identify and quantify severity of depression in a clinical sample of females with CWP. The observed item endorsement pattern indicated that, in this study population, the relatively high depression severity scores primarily pertained to a common core of pain-related somatic symptoms. Careful consideration when interpreting questionnaire-derived scores of depression implemented in research and routine clinical care of patients with chronic pain is warranted.

SUMMARY All generalist and specialist clinicians are likely to encounter torture survivors among refugees and asylum seekers. A minority of people survive torture and a smaller minority reach a developed country; those who do tend to be the more resilient and resourceful. They have many health, social and welfare problems; persistent pain in the musculoskeletal system is one of the most common. There is little specific evidence on pain in survivors of torture; the guidelines on interdisciplinary specialist management are applicable. Most of the literature on refugee survivors of torture has an exclusive focus on psychological disorders, with particularly poor understanding of pain problems. This article summarizes the current status of assessment and treatment of pain problems in the torture survivor.

Background: Persistent (chronic) pain is a frequent complaint in survivors of torture, particularly but not exclusively pain in the musculoskeletal system. Torture survivors may have no access to health care; where they do, they may not be recognised when they present, and the care available often falls short of their needs. There is a tendency in state and non-governmental organisations' services to focus on mental health, with poor understanding of persistent pain, while survivors may have many other legal, welfare, and social problems that take precedence over health care. Objectives: To assess the efficacy of interventions for treating persistent pain and associated problems in survivors of torture. Search methods: We searched for randomised controlled trials (RCTs) published in any language in CENTRAL, MEDLINE, Embase, Web of Science, CINAHL, LILACS, and PsycINFO, from database inception to 1 February 2017. We also searched trials registers and grey literature databases. Selection criteria: RCTs of interventions of any type (medical, physical, psychological) compared with any alternative intervention or no intervention, and with a pain outcome. Studies needed to have at least 10 participants in each arm for inclusion. Data collection and analysis: We identified 3578 titles in total after deduplication; we selected 24 full papers to assess for eligibility. We requested data from two completed trials without published results. We used standard methodological procedures expected by Cochrane. We assessed risk of bias and extracted data. We calculated standardised mean difference (SMD) and effect sizes with 95% confidence intervals (CI). We assessed the evidence using GRADE and created a 'Summary of findings' table. Main results: Three small published studies (88 participants) met the inclusion criteria, but one had been retracted from publication because of ethical problems concerned with confidentiality and financial irregularities. Since these did not affect the data, the study was retained in this review. Despite the search including any intervention, only two types were represented in the eligible studies: two trials used cognitive behavioural therapy (CBT) with biofeedback versus waiting list on unspecified persistent pain (58 participants completed treatment), and one examined the effect of complex manual therapy versus self-treatment on low back pain (30 participants completed treatment). Excluded studies were largely either not RCTs or did not report pain as an outcome. There was no difference for the outcome of pain relief at the end of treatment between CBT and waiting list (two trials, 58 participants; SMD -0.05, 95% CI -1.23 to 1.12) (very low quality evidence); one of these reported a three-month follow-up with no difference between intervention and comparison (28 participants; SMD -0.03, 95% CI -0.28 to 0.23) (very low quality evidence). The manual therapy trial also reported no difference between complex manual therapy and self-treatment (30 participants; SMD -0.48, 95% CI -9.95 to 0.35) (very low quality evidence). Two studies reported dropouts, one with partial information on reasons; none of the studies reported adverse effects. There was no information from any study on the outcomes of use of analgesics or quality of life. Reduction in disability showed no difference at the end of treatment between CBT and waiting list (two trials, 57 participants; SMD -0.39, 95% CI -1.17 to 0.39) (very low quality evidence); one of these reported a three-month follow-up with no difference between intervention and comparison (28 participants; SMD 0, 95% CI -0.74 to 0.74) (very low quality evidence). The manual therapy trial reported superiority of complex manual therapy over self-treatment for reducing disability (30 participants; SMD -1.10, 95% CI - 1.88 to -0.33) (very low quality evidence). Reduction in distress showed no difference at the end of treatment between CBT and waiting list (two trials, 58 participants; SMD 0.07, 95% CI -0.46 to 0.60) (very low quality evidence); one of these reported a three-month follow-up with no difference between intervention and comparison (28 participants; SMD -0.24, 95% CI -0.50 to 0.99) (very low quality evidence). The manual therapy trial reported superiority of complex manual therapy over self-treatment for reducing distress (30 participants; SMD -1.26, 95% CI - 2.06 to -0.47) (very low quality evidence). The risk of bias was considered high given the small number of trials, small size of trials, and the likelihood that each was underpowered for the comparisons it reported. We primarily downgraded the quality of the evidence due to small numbers in trials, lack of intention-to-treat analyses, high unaccounted dropout, lack of detail on study methods, and CIs around effect sizes that included no effect, benefit, and harm. Authors' conclusions There is insufficient evidence to support or refute the use of any intervention for persistent pain in survivors of torture.

Background Fatigue has been identified as one of the most significant symptoms and an outcome of great importance to patients with psoriatic arthritis (PsA), but the association between underlying components of experienced fatigue and the disease has been sparsely investigated. [1] Objectives To describe the degree of fatigue in a PsA population. Secondly, to explore which components of inflammation and non-inflammatory factors contribute to experienced fatigue. Methods The study was designed as a cross-sectional survey including patients registered in DANBIO, the Danish nationwide rheumatologic registry, from December 2013 to June 2014. Principal component analysis was used to identify clustering factors associated with fatigue Results A total of 1,062 PsA patients were included in the study. The median Visual Analog Scale (VAS) fatigue score was 57mm. Patients with moderate to severe fatigue (VAS score ≥57) had higher scores of pain, DAS28, HAQ, patient global assessment, and more tender and swollen joints (p Conclusions Clinical inflammatory disease activity, chronification, as well as pain in the absence of inflammation were all identified as important factors explaining 63% of moderate to severe fatigue in the current PsA population. References Orbai AM, Mease PJ, de WM et al. Report of the GRAPPA-OMERACT Psoriatic Arthritis Working Group from the GRAPPA 2015 Annual Meeting. J Rheumatol 43; 965–9. Acknowledgements This study was supported by the Oak Foundation. Data was extracted from the DANBIO Registry. Disclosure of Interest M. Skougaard: None declared, T. Jorgensen Speakers bureau: Abbvie, Roche, UCB, Novartis, Biogen, S. Rifbjerg-Madsen: None declared, L. Coates Grant/research support from: Abbvie, BMS, Celgene, Jannsen Pharmaceuticals, Lilly, MSD, Novartis, Pfizer, Sun Pharma, UCB, A. Egeberg Grant/research support from: Pfizer, Eli Lilly, Speakers bureau: Pfizer, Eli Lilly, Novartis, Galderma, Janssen Pharmaceuticals, K. Amris: None declared, L. Dreyer: None declared, P. Hojgaard Speakers bureau: Celgene, UCB, J. Guldberg-Moller Paid instructor for: Abbvie, J. Merola Grant/research support from: Biogen IDEC, Amgen, Pfizer, Boehringer Ingelheim, Consultant for: Biogen IDEC, Eli Lilly, Novartis, Momenta, UCB, Kiniksa, AbbVie, Amgen, Pfizer, Janssen Pharmaceuticals, Momenta, Mallinckrodt, Speakers bureau: AbbVie, Eli Lilly, P. Frederiksen: None declared, H. Gudbergsen Speakers bureau: MSD, Pfizer, L. E. Kristensen Speakers bureau: Pfizer, AbbVie, Amgen, UCB, Celgene, BMS, MSD, Novartis, Eli Lilly, Janssen Pharmaceuticals.

BACKGROUND: Pain is inherent in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (SpA) and traditionally considered to be of nociceptive origin. Emerging data suggest a potential role of augmented central pain mechanisms in subsets of patients, thus, valid instruments that can identify underlying pain mechanisms are needed. The painDETECT questionnaire (PDQ) was originally designed to differentiate between pain phenotypes. The objectives were to evaluate the psychometric properties of the PDQ in patients with inflammatory arthritis by applying Rasch analysis and to explore the reliability of pain classification by test-retest.METHODS: For the Rasch analysis 900 questionnaires from patients with RA, PsA and SpA (300 per diagnosis) were extracted from 'the DANBIO painDETECT study'. The analysis was directed at the seven items assessing somatosensory symptoms and included: 1) the performance of the six-category Likert scale; 2) whether a unidimensional construct was defined; 3) the reliability and precision of estimates. Another group of 30 patients diagnosed with RA, PsA or SpA participated in a test-retest study. Intraclass Correlation Coefficients (ICC) and classification consistency were calculated.RESULTS: The Rasch analysis revealed: (1) Acceptable psychometric rating scale properties; the frequency distribution peaked in category 0 except for item 5, threshold calibration >10 observations per category, no disorder in the category measures for all items, scale category outfit Mnsq CONCLUSION: The results support that the PDQ can be used as a classification instrument and assist identification of underlying pain-mechanisms in patients suffering from inflammatory arthritis.

The EULAR recommendations for the management of fibromyalgia are based on more than 100 reviews and meta-analyses of individual therapies and medicines.1 Thus, the quality of the evidence in making recommendations on effectiveness and efficacy is generally very high. In contrast, there is little published research …

ObjectiveThe original European League Against Rheumatism recommendations for managing fibromyalgia assessed evidence up to 2005. The paucity of studies meant that most recommendations were ‘expert opinion’.MethodsA multidisciplinary group from 12 countries assessed evidence with a focus on systematic reviews and meta-analyses concerned with pharmacological/non-pharmacological management for fibromyalgia. A review, in May 2015, identified eligible publications and key outcomes assessed were pain, fatigue, sleep and daily functioning. The Grading of Recommendations Assessment, Development and Evaluation system was used for making recommendations.Results2979 titles were identified: from these 275 full papers were selected for review and 107 reviews (and/or meta-analyses) evaluated as eligible. Based on meta-analyses, the only ‘strong for’ therapy-based recommendation in the guidelines was exercise. Based on expert opinion, a graduated approach, the following four main stages are suggested underpinned by shared decision-making with patients. Initial management should involve patient education and focus on non-pharmacological therapies. In case of non-response, further therapies (all of which were evaluated as ‘weak for’ based on meta-analyses) should be tailored to the specific needs of the individual and may involve psychological therapies (for mood disorders and unhelpful coping strategies), pharmacotherapy (for severe pain or sleep disturbance) and/or a multimodal rehabilitation programme (for severe disability).ConclusionsThese recommendations are underpinned by high-quality reviews and meta-analyses. The size of effect for most treatments is relatively modest. We propose research priorities clarifying who will benefit from specific interventions, their effect in combination and organisation of healthcare systems to optimise outcome.

BACKGROUND: Central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The painDETECT questionnaire (PDQ) identifies neuropathic pain features, which may act as a proxy for centrally mediated pain. The objectives were to quantify and characterize pain phenotypes (non-neuropathic vs. neuropathic features) among Danish arthritis patients using the PDQ, and to assess the association with on-going inflammation.METHODS: The PDQ was included onto the DANBIO touch screens at 22 departments of Rheumatology in Denmark for six months. Clinical data and patient reported outcomes were obtained from DANBIO. A PDQ-score >18 indicated neuropathic pain features, 13-18 unclear pain mechanism and RESULTS: Pain data (visual analogue scale, VAS) was available for 15,978 patients. 7,054 patients completed the PDQ (RA: 3,826, PsA: 1,180, SpA: 1,093). 52% of all patients and 63% of PDQ-completers had VAS pain score ≥ 30 mm. The distribution of the PDQ classification-groups (18) were; RA: 56%/24%/20%. PsA: 45%/ 27%/ 28%. SpA: 55% / 24%/ 21%. More patients with PsA had PDQ score >18 compared to RA and SpA (p 18 significantly higher scores were found for all patient reported outcomes and disease activity scores. No clinical difference in CRP or swollen joint count was found. Logistic regression showed increased odds for having VAS pain ≥39 mm (the median) for a PDQ-score >18 compared to CONCLUSIONS: More than 50% of the Danish arthritis patients reported clinically significant pain. More than 20% of the PDQ-completers had indication of neuropathic pain features, which was related to a high pain-level. PDQ-score was associated with DAS28-CRP and VAS pain but not with indicators of peripheral inflammation (CRP and SJC). Thus, pain classification by PDQ may assist in mechanism-based pain treatment.

Objective: To evaluate the relationships between key outcome variables, classified according to the International Classification of Functioning, Disability and Health (ICF), and observed and self-reported functional ability in patients with chronic widespread pain. Design: Cross-sectional with systematic data collection in a clinical setting. Subjects: A total of 257 consecutively enrolled women with chronic widespread pain. Methods: Multidimensional assessment using self-report and observation-based assessment tools identified to cover ICF categories included in the brief ICF Core Set for chronic widespread pain. Results: Relationships between ICF variables and observed functional ability measured with the Assessment of Motor and Process Skills (AMPS) were few. Out of 36 relationships analysed, only 4 ICF variables showed a moderate correlation with the AMPS motor ability measure. A moderate to strong correlation between numerous ICF variables and self-reported functioning was noted. Multivariate regression modelling supported significant contributions from pain and psychosocial variables to the variability in self-reported functional ability, but not to the variability in AMPS ability measures. Conclusion: Observation-based assessment of functional ability in patients with chronic widespread pain is less influenced by pain and psychosocial factors than are self-reported evaluations. Valid observation-based assessment tools, such as the AMPS, should be included in clinical evaluation and future research addressing functional outcomes in this patient population.

Torture and the conditions under which it is inflicted often leave persistent painful disorders. Because there may be no lasting signs, persistent pain is often misconceived as a somatic representation of psychological distress, also common after torture. This serious failure to understand the nature of persistent pain means that pain is largely overlooked and untreated in torture survivors. We carried out a systematic review on treatments for pain from torture, but found few studies and little use of current understanding and evidence. We discuss this in the context of treating pain associated with psychological distress and of the broader problems faced by the refugee and torture survivor that may take priority over pain. We propose clinical and research implications for this neglected field.

Objective . The aim of this study was to examine the association between physical fitness and depressive symptoms in women with fibromyalgia (FM). We also assessed whether different fitness components present independent relationships with depressive symptoms. Design . Cross-sectional study. Setting . University facilities and FM associations. Subjects . Four hundred and forty-four patients with FM according to the 1990 American College of Rheumatology criteria. Methods . Depressive symptoms were assessed using the Beck Depression Inventory (BDI-II). Physical fitness (aerobic fitness, muscle strength, flexibility, and motor agility) was assessed using the standardized Senior Fitness Test battery and the handgrip strength test. A standardized composite score for fitness was computed and divided into quintiles. Results . Overall, the fitness tests presented inverse associations with the total BDI-II score ( P

Background: The painDETECT questionnaire (PDQ) is a mechanism-based pain classification tool assigning patients to one of three categories depending on the quality of the experienced pain. Patients with non-nociceptive pain score high on the PDQ. The objective was to assess the proportions of the three PDQ classification groups in patients with rheumatoid arthritis (RA) and to explore differences in clinical characteristics. Method: RA patients initiating or escalating their RA therapy were included prospectively and underwent a thorough examination programme. Low (PDQ score < 13), medium (PDQ score 13–18), and high (PDQ score > 18) scores indicate nociceptive, unclear/possible neuropathic, or neuropathic pain mechanisms, respectively. Results: The 102 included patients were classified into the following PDQ classification groups: low = 65%, medium = 23%, and high = 12%. Patients in the medium and high PDQ groups scored worse on indicators of anxiety, depression, disability, mental health-related quality of life, pain, and fatigue. They also had more tender points and an RA disease activity score based on 28 joints (DAS28) where a higher fraction of the composite score pertained to non-inflammatory factors compared to patients in the low PDQ classification group. There were no differences in objective inflammatory indices across groups. Multiple regression analysis demonstrated that the tender joint count (TJC) and the 36-item Short Form Health Survey (SF36) mental component summary (MCS) score were independently associated with the PDQ score. Conclusions: In patients initiating or intensifying medical treatment for their RA, non-nociceptive pain (PDQ score ≥ 13) is common. In these patients, the pain mechanisms result in increased disease activity scores on a non-inflammatory basis.

OBJECTIVE: To investigate predictors of improvement in observed ability to manage activities of daily living as an outcome of rehabilitation in fibromyalgia.METHODS: Exploratory analyses used data from the Interdisciplinary Rehabilitation and Evaluation Programme for Patients with Chronic Widespread Pain (the IMPROvE study); a randomized controlled trial including 191 females with fibromyalgia randomized (1:1) to rehabilitation or a waiting list. The primary outcome was observed activities of daily living ability evaluated with the Assessment of Motor and Process Skills (AMPS) 6 months post-intervention.RESULTS: Overall, 38.7% of subjects were AMPS responders, i.e. having a clinically meaningful improvement in AMPS activities of daily living ability measures at 6 months post-intervention. In the exploratory analysis, only 4 baseline variables out of the 52 analysed showed a statistically significant interaction with treatment allocation (at the 0.05 level) indicating possible predictive value. Statistical analyses that used continuous variables dichotomized at the median suggested a predictive value of a low intake of weak and strong analgesics, and a high score of current pain and total score on the Pain Detect Questionnaire.CONCLUSION: The results of this exploratory study suggest that several subgroups of patients, specifically those with a low baseline intake of weak and strong analgesics, and more pronounced clinical signs of central sensitization, may gain most clinical benefit from specialized rehabilitation when the outcome of interest is improvement in observed activity of daily living ability.

Objective: To investigate whether the Assessment of Motor and Process Skills (AMPS), the physical function subscales of the Fibromyalgia Impact Questionnaire (FIQ PF) and the 36-item Short Form (SF-36 PF) can identify subgroups of women with fibromyalgia with clinically relevant differences in ability to perform activities of daily living. Design: Cross-sectional study. Subjects: A total of 257 women with fibromyalgia. Methods: Participants were evaluated with the AMPS (measuring activities of daily living motor and activities of daily living process ability), FIQ and SF-36. AMPS independence cut-offs were used to divide the participants into 4 subgroups. Clinically relevant differences between subgroups were investigated based on the AMPS, FIQ PF and SF-36 PF. Result: Participants in the 4 AMPS-derived subgroups demonstrated clinically relevant differences in observed activities of daily living motor and process ability. Neither the FIQ PF nor the SF-36 PF could differentiate between subgroups with clinically relevant differences in AMPS activities of daily living process ability. Conclusion: Activities of daily living process skills reflect underlying organizational and adaptive capacities of the individual and are relevant targets for interventions aiming at improving activities of daily living ability. Since self-report instruments do not capture differences in activities of daily living process ability, clinicians should include observationsbased assessment of activities of daily living ability in order to individualize interventions offered.

Objective To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs)) for rheumatoid arthritis (RA). Methods We conducted a meta-epidemiological study of all trials evaluating a targeted therapy approved by regulatory authorities for treating RA. The database search was completed on December 11th 2013. Eligible trials reported ACR20 data at months 3–6 and used an add-on design. Odds ratios (ORs) were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR). Results Sixty-two trials (19,923 RA patients) were included in the primary analyses using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI) 3.41 to 4.60). The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower in trials including "DMARD-naive" patients compared with trials including "DMARD inadequate responders" (ROR = 0.45, 95%CI 0.31 to 0.66) and trials including "targeted therapy inadequate responders" (0.50, 95%CI 0.29 to 0.87), test for interaction: p = 0.0002. Longer mean disease duration was associated with a higher likelihood of responding to treatment (β = 1.05, 95%CI 1.00 to 1.11 OR’s per year; p = 0.03). Analyses conducted using DAS28-remission as the outcome supported the above-mentioned findings. Conclusion Our results suggest that a highly selective inclusion is not associated with greater treatment effect, as might otherwise be expected. The added benefit of a targeted therapy was lower in trials including patients who were DMARD-naive and trials including patients with shorter disease durations.

Objective: The aim of this study was to evaluate the extent of Activities of Daily Living (ADL) ability impairment in newly arrived Danish asylum seekers. It was hypothesized that exposure to trauma and torture would negatively influence ADL performance and that measures of ADL ability would be lower in individuals exposed to torture as compared to the non-tortured. Subjects: Forty-three newly arrived asylum seekers aged 20-50 years, from Iran, Afghanistan, and Syria, were consecutively included in the study. Method: ADL ability was assessed with the observation-based test Assessment of Motor and Process Skills (AMPS). Interviews were based on questionnaires about torture exposure, WHO-5 Wellbeing Index, Major Depression Inventory and Pain Detect Questionnaire. All participants were interviewed and tested using a linguistic interpreter. Results: Thirty-three (77%) participants reported exposure to torture. The tortured did not differ significantly from the non-tortured on measures of ADL ability (two-sample t-tests: Motor, p= 0.36; Process, p= 0.82). ADL performance impairment was observed in the overall study sample. Twelve had motor and 15 process ability measures below age norms and 2 below both AMPS motor and process cut-offs for effortless and efficient ADL performance. There were statistically significant - weak to moderate - correlations between self-reported psychological distress, VAS average pain, pain distribution, and the AMPS measures. Conclusion: The study results supported significant ADL ability impairment in tortured as well as non-tortured newly arrived asylum seekers. Implementation of performance-based evaluation of ADL ability as part of the initial medical screening of this particular population should be considered.

Aim: The aim of this study was to describe asylum seekers' satisfaction with daily occupations and activity level while in a Danish asylum centre, and whether this changed over time. Another aim was to describe whether exposure to torture, self-rated health measures, and ADL ability were related to their satisfaction with daily occupations and activity level. Methods: A total of 43 asylum seekers at baseline and 17 at follow-up were included. The questionnaires Satisfaction with Daily Occupations, Major Depression Inventory, WHO-5 Wellbeing, Pain Detect, a questionnaire covering torture, and basic social information were used as well as Assessment of Motor and Process Skills. Results: The results showed a low level of satisfaction with daily occupations at both baseline and follow-up. There was no statistically significant change in satisfaction or activity level between baseline and the follow-up. Associations between AMPS process skills -education, worst pain and activity level -were present at baseline, as was a relationship between AMPS process skills and satisfaction. At follow-up, associations between WHO-5 and satisfaction and activity level and between MDI scores and activity level were found. Conclusion: Asylum seekers experience a low level of satisfaction with daily occupations, both at arrival and after 10 months in an asylum centre. There is a need for further research and development of occupation-focused rehabilitation methods for the asylum seeker population.

Introduction Pain in rheumatoid arthritis (RA) is traditionally considered to be of inflammatory origin. Despite better control of inflammation, some patients still report pain as a significant concern, even when being in clinical remission. This suggests that RA may prompt central sensitisation—one aspect of chronic pain. In contrast, other patients report good treatment response, although imaging shows signs of inflammation, which could indicate a possible enhancement of descending pain inhibitory mechanisms. When assessing disease activity in patients with central sensitisation, the commonly used disease activity scores (eg, DAS28-CRP (C reactive protein)) will yield constant high total scores due to high tender joint count and global health assessments, whereas MRI provides an isolated estimate of inflammation. The objective of this study is, in patients with RA initiating anti-inflammatory treatment, to explore the prognostic value of a screening questionnaire for central sensitisation, hand inflammation assessed by conventional MRI, and the interaction between them regarding treatment outcome evaluated by clinical status (DAS28-CRP). For the purpose of further exploratory analyses, dynamic contrast-enhanced MRI (DCE-MRI) is performed. Method and analysis The painDETECT Questionnaire (PDQ), originally developed to screen for a neuropathic pain component, is applied to indicate the presence of central sensitisation. Adults diagnosed with RA are included when either (A) initiating disease-modifying antirheumatic drug treatment, or (B) initiating or switching to biological therapy. We anticipate that 100 patients will be enrolled, tested and reassessed after 4 months of treatment. Data collection includes Clinical data, conventional MRI, DCE-MRI, blood samples and patient-reported outcomes. Ethics and dissemination This study aims at supporting rheumatologists to define strategies to reach optimal treatment outcomes in patients with RA based on chronic pain prognostics. The study has been approved by The Capital region of Denmark9s Ethics Committee; identification number H-3-2013-049. The results will be published in international peer-reviewed journals.

Introduction Chronic pain is common in rheumatoid arthritis (RA) and may still persist despite regression of objective signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in RA. Application of the disease activity score DAS28 can classify some patients with active RA solely based on a high tender joint count and poor patient global health score. In such cases, intensified treatment with anti-inflammatory drugs would be expected to yield poorer results than in cases with DAS28 elevation due to a high score for swollen joints and C reactive protein (CRP). Evaluation of central pain sensitisation in patients with few inflammatory indices may be a predictive tool regarding the effect of anti-inflammatory treatment. Computerised pneumatic cuff pressure algometry (CPA) is a method for assessing temporal summation (ie, degree of central sensitisation). The main objective of this study was to examine the prognostic values of pressure pain-induced temporal summation, ultrasound Doppler activity and the interaction between them in relation to treatment response (DAS28-CRP change) in patients with RA initiating any anti-inflammatory therapy. Method and analysis 120 participants ≥18 years of age will be recruited. Furthermore, they must be either (1) diagnosed with RA, untreated with disease-modifying antirheumatic drugs for at least 6 months and about to initiate disease-modifying antirheumatic drug treatment or (2) about to begin or switch treatment with any biological drug for their RA. Data (clinical, imaging, blood samples, patient reported outcomes and CPA measurements) will be collected from each participant at baseline and after 4 months of anti-inflammatory treatment. Ethics and dissemination This study has been approved by the ethics committee for the Copenhagen region (H-4-2013-007). Dissemination will occur through presentations and publication in international peer-reviewed journals.

The clinical utility of tender point (TP) examination in patients reporting chronic widespread pain (CWP) is the subject of contemporary debate. The objective of this study was to assess the relationship between mechanical hyperalgesia assessed by manual TP examination and clinical disease severity. 271 women with CWP were recruited from a clinical setting. Data collection included patient-reported symptoms, health-related quality of life variables, and observation-based measures of functional ability, muscle strength, 6-minute walk, and pressure pain thresholds measured by cuff algometry. TP examination was conducted according to ACR-guidelines. Relationships between disease variables and TP count (TPC) were analyzed with logistic regression in a continuum model, allowing the TPC to depend on the included disease variables and two regression models carried out for a TPC threshold level, varying between 1 and 17. The threshold analyses indicated a TPC threshold at 8, above which a large number of disease variables became consistently significant explanatory factors, whereas none of the disease variables reached a significance level in the continuum model. These results support the premise that the presence of mechanical hyperalgesia influences symptomatology in CWP and that the severity of clinical expression is related to a threshold of TPs, rather than being part of a continuum.

OBJECTIVE.: To assess pain sensitivity and spreading hyperalgesia in lateral epicondylalgia (LE). SUBJECTS.: Twenty-two women with LE, and 38 controls were included. OUTCOME MEASURES.: Computerized cuff pressure algometry was used for assessment of pressure-pain threshold and tolerance. The stimulus was applied using a single (stimulation-area: 241 cm(2) ) or double-chambered (stimulation-area: 482 cm(2) ) tourniquet on the arm and leg. Spatial summation was expressed as the ratio between pressure-pain thresholds to single and double cuff-chamber stimulation. During 10-minute constant pressure stimulation at intensity relative to the individual pain threshold, the pain intensity was continuously recorded using an electronic visual analogue scale (VAS), and from this the degree of temporal summation was estimated. For LE, a Doppler ultrasound examination of the elbow was made to identify inflammation. RESULTS.: In LE compared with controls the pressure-pain threshold and tolerance were on average reduced by respectively 31% (nonsignificant) and 18% (nonsignificant) on the lower arm and by 32% (P < 0.05) and 22% (P < 0.05) on the lower leg (spreading sensitization). Within the LE group, pressure-pain thresholds were on average reduced by 20% (P < 0.05) and pain tolerance by 10% (nonsignificant) on the painful compared with the asymptomatic side. Spatial summation (P < 0.01) and temporal summation (P < 0.05) was facilitated in LE compared with controls. In LE patients without signs of peripheral inflammation assessed by Doppler ultrasound, temporal summation was significantly stronger than in patients with ongoing inflammation (P < 0.01). CONCLUSION.: Patients with LE may be subgrouped based on pain hypersensitivity and Doppler ultrasound into clinically meaningful subgroups with varying duration of symptoms and different degrees of central sensitization. These groups may require different pain management strategies.

INTRODUCTION: Persistent pain is a major concern for patients with psoriatic arthritis (PsA). Pain may be due to inflammatory activity or augmented central pain processing. Unawareness of the origin and mechanisms of pain can lead to misinterpretation of disease activity (by composite scores) and erroneous treatments. Ultrasonography (US) is a highly sensitive method to detect tissue inflammation. Evaluating pain mechanisms in relation to US measures may prove valuable in predicting response to treatment in PsA.AIMS: To study the association and prognostic value of pain mechanisms, ultrasonic activity and clinical outcomes in patients with PsA who intensify antirheumatic treatment.METHODS AND ANALYSES: 100 participants >18 years of age with PsA who initiate or switch antirheumatic treatment (biologicals and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs)) will be prospectively recruited from outpatient clinics in Copenhagen. All data (demographics, clinical, imaging, blood samples and patient-reported outcomes) will be collected at baseline and after 4 months. Pain is assessed by the PainDETECT Questionnaire, Visual Analogue Scale for pain, Swollen to Tender Joint Count Ratio, Widespread Pain Index and tender point examination. The association between pain variables and clinical/US characteristics will be described by correlation analyses. The predictive value of pain measures and baseline US scores on treatment response will be analysed with regression models. Outcomes are composite and clinical, as well as patient reported.ETHICS AND DISSEMINATION: The study is approved by the ethics committee of the Capital Region of Denmark (H-15009080) and has been designed in cooperation with patient research partners. The study is registered at clinicaltrials.gov (number NCT02572700). Results will be disseminated through publication in international peer-reviewed journals.TRIAL REGISTRATION NUMBER: NCT02572700, Pre-results.

To investigate whether signs of chronic compartment syndrome could be found in plantar muscles of falanga torture victims with painful feet and impaired gait. The hypothesis was that the muscular vascular response to two minutes ischemia would be decreased in torture victims compared to controls. On color Doppler this would be seen as less color after ischemia and on spectral Doppler as elevated resistive index (RI).Ten male torture victims from the Middle East and nine age, sex and ethnically matched controls underwent Doppler examination of the abductor hallucis and flexor digitorum brevis muscles before and after two minutes ischemia induced with a pressure cuff over the malleoli. The color Doppler findings were quantified with the color fraction (CF) before and after ischemia. On spectral Doppler the resistive index was measured once before and three consecutive times after ischemia.Both torture victims and controls responded to ischemia with an increased CF. There was no difference between torture victims and controls. With spectral Doppler all subjects had an RI of 1.0 before ischemia. After ischemia, in nearly all subjects and all muscles the first RI was lowest, the second was higher and the third was highest indicating that the response to ischemia was disappearing as measurements were made. There was a trend that the first RI was higher in torture victims than in controls.The study was not able to confirm the presence of chronic compartment syndrome. However, the trend in RI still supports the hypothesis. The negative findings may be due to inadequate design where the CF and RI were measured in one setting, perhaps resulting in both methods being applied imperfectly. The response to ischemia seems short-lived and we suggest that the Doppler methods may be re-evaluated with separate ischemic phases for CF and RI.

Medico-legal documentation of alleged exposure to falanga torture warrants a high diagnostic accuracy of the applied clinical tests. The objective of this study was to establish data on the validity of palpatory examination of the footpads and the plantar fascia and to assess the distribution of observations among selected cases and non-cases in a small study sample. Calculated estimates of sensitivity and specificity of the individual diagnostic tests are reported and, in general, did not meet the authority-based criteria of an 80% cut-off point. The observed total number of true tests in this study was 65 %. It is concluded that future studies of the reliability of clinical examination and assessment of the variability of observations among unselected cases and non-cases should be conducted in a larger cross-sectional study population.

The long-term consequences of falanga are probably the best described consequences of exposure to specific forms of physical torture. Theories about casual lesions in the peripheral tissues of the feet have been put forward based on clinical observations along with international guidelines for the clinical assessment, but still knowledge is needed in several areas. A review of the literature on falanga is presented, mainly focusing on the clinical aspects and possible lesions caused by this specific form of torture that may influence the overall management of the condition. Finally, the article closes with a call for future research, which is needed in order to advance a knowledge-based development of the applied clinical practice.

Five British men were detained and allegedly tortured in Saudi Arabia in 2000 and 2001. Two were sentenced to death and three were sentenced to 12 to 18 years of imprisonment. They received clemency in 2003 and were deported to England. After their homecoming, the men have unsuccessfully attempted to sue Saudi Arabian officials who had been responsible for their false accusations and human rights abuses. Saudi Arabia denies any form of torture and ill treatment of the five men, who maintain their allegations against the authorities responsible in Saudi Arabia. This article provides medical documentation of torture of the five British men by comparing: 1. Alleged torture methods, 2. Histories of immediate effects of torture, 3. Objective medical observations using clinical examinations as well as ultrasound scans of the victims' feet. The article concludes that there is a high degree of consistency between the claims of torture and observations, despite Saudi Arabian denial.

Falanga torture involves repetitive blunt trauma to the soles of the feet and typically leaves few detectable changes. Reduced elasticity in the heel pads has been reported as characteristic sequelae and palpatory testing of heel pad elasticity is therefore part of medicolegal assessment of alleged torture victims.The goal was to test the accuracy of two experienced investigators in determining whether a heel pad model was soft, medium or hard. The skin-to-bone distance in the models varied within the human range.Two blinded investigators independently palpated nine different heel pad models with three different elasticities combined with three different skin-to-bone distances in five consecutive trials and categorized the models as soft, medium or hard.Two experienced investigators were able to identify three known elasticities correctly in approximately two thirds of the cases. The skin-to-bone distance affected the accuracy.The use of clinical examination in documenting alleged exposure to torture warrants a high diagnostic accuracy of the applied tests. The study implies that palpatory testing of the human heel pad may not meet this demand. It is therefore recommended that a device able to perform an accurate measurement of the viscous-elastic properties of the heel pad be developed.