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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.

Objectives With the International Classification of Diseases 11th revision (classifying fibromyalgia as a primary pain disorder) soon to be implemented, the importance of pain physicians being able to identify patients with fibromyalgia is emphasized. The diagnostic criteria proposed in 2016 are based on self-reported pain distribution and symptom severity. The study aimed to evaluate the diagnostic accuracy of the 2016 diagnostic criteria for fibromyalgia applied in a population of patients with high impact chronic pain referred for pain rehabilitation. Methods The study was performed as a diagnostic accuracy study at two Danish interdisciplinary pain rehabilitation centers, including 215 participants. All participants were evaluated clinically to identify patients with fibromyalgia. The diagnosis was based on expert opinion, but the minimum requirements were: (1) pain in all four body quadrants and axially for at least three months and (2) minimum 8 of 18 positive tender points. Participants filled in the fibromyalgia survey questionnaire, the patient version of the 2016 diagnostic criteria. Sensitivity, specificity, likelihood ratios, and positive and negative post-test probabilities were calculated using a clinical diagnosis of fibromyalgia as the reference standard. Results Based on clinical diagnosis 45% of the participants were diagnosed with fibromyalgia; of these, only 19% had been diagnosed previously. The 2016 diagnostic criteria demonstrated a sensitivity of 88.5%, a specificity of 81.5%, a positive likelihood ratio of 4.79, a negative likelihood ratio of 0.14, a positive post-test probability of 79.4%, and a negative post-test probability of 10.2%. Conclusions Fibromyalgia was severely under-diagnosed among patients with high impact chronic pain referred to tertiary care in two pain rehabilitation centers in Denmark. The 2016 diagnostic criteria showed sufficient discriminatory properties suggesting that the fibromyalgia survey questionnaire can be used as a screening tool assisting the identification of fibromyalgia in this patient population.

To evaluate the relationship between self-reported and performance-based measures of functioning in rheumatoid arthritis (RA), knee osteoarthritis (OA), and fibromyalgia (FM), and the influence of pain and fatigue.Self-reported functioning was assessed by the Stanford Health Assessment Questionnaire, Fibromyalgia Impact Questionnaire, and Knee injury and Osteoarthritis Outcome Score. Performance-based measures of task-related physical activity included grip strength and Six-Minute Walk Test (6MWT). Assessment of Motor and Process Skills (AMPS) was used to obtain performance-based measures of activities of daily living (ADL) ability. Pain and fatigue were assessed by 100 mm visual analogue scales. Spearman's rho correlation and regression modelling were applied.Correlations between self-reported functioning and performance-based measures of ADL ability were weak to moderate, and strongest in OA (r = 0.57, p = 0.002), and AMPS ADL ability measures did not enter regression models as explanatory factors for self-reported functioning. Correlations between AMPS ADL ability measures and measures of task-related physical activity were weak, except for a strong correlation between AMPS ADL motor ability and 6MWT in OA (r = 0.63, p = 0.000). The 6MWT was the only performance-based test explaining variance in AMPS motor ability (OA = 42%; FM = 11%). Pain explained variance in self-reported ability and contributed to variance in AMPS ADL motor ability measures in OA.Self-reported and observed measures of functioning assess partly different aspects of functioning, and both approaches may therefore be relevant in a structured assessment of patients with musculoskeletal disorders.

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: To evaluate the benefit of adding occupational therapy or physiotherapy interventions to a standard rehabilitation programme targeted for chronic widespread pain. Design: Randomized active-controlled non-blinded trial. Subjects: Women with chronic widespread pain recruited in a tertiary outpatient clinic. Methods: Participants were randomized to a two-week, group-based standard rehabilitation programme followed by 16 weeks of group-based occupational therapy (Group BOT, n = 43) or 16 weeks of group-based physiotherapy (Group BPT, n = 42). Group A only received the two-week rehabilitation programme acting as comparator ( n = 96). Outcomes: Primary outcomes were the Assessment of Motor and Process Skills and Short Form-36 (SF36) Mental Component Summary score. Results: Mean changes in motor and process ability measures were clinically and statistically insignificant and without differences across the three groups assessed 88 weeks from baseline. Motor ability measures: −0.006 (95% confidence interval (CI): −0.244 to 0.233) in Group BOT; −0.045 (95% CI: −0.291 to 0.202) in Group BPT; and −0.017 (95% CI: −0.248 to 0.213) in Group A, P = 0.903. Process ability measures: 0.087 (95% CI: −0.056 to 0.231) in Group BOT; 0.075 (95% CI: −0.075 to 0.226) in Group BPT; and 0.072 (95% CI: −0.067 to 0.211) in Group A, P = 0.924. Mean changes in patient-reported outcomes were likewise small; clinically and statistically insignificant; and independent of group allocation, except for the SF36 mental component summary score in the BPT group: 8.58 (95% CI: 1.75 to 15.41). Conclusion: Participants were on average stable in observation-based measures of functional ability and patient-reported outcomes, except in overall mental well-being, favouring the enhanced intervention. Efficacy of additional interventions on functional ability remains uncertain.

To assess the association between physical fitness and fibromyalgia (FM) severity in women with FM as well as to assess whether different fitness components present an independent relation with FM severity.Population-based cross-sectional study.University facilities and FM associations.Women with FM (N=444).Not applicable.FM severity was assessed with the Revised Fibromyalgia Impact Questionnaire (FIQR). Aerobic fitness (6-min walk test), muscle strength (handgrip, chair stand, and arm curl tests), flexibility (chair sit and reach and back scratch tests), and motor agility (8 foot Up and Go test) were measured with the Senior Fitness Test battery and digital dynamometry. A standardized composite score (hereafter "global fitness profile") was calculated and divided into quintiles.Overall, physical fitness was significantly associated with the FIQR total and subscale scores, regardless of the fitness test used (all P.05). The 6-minute walk and back-scratch tests were independently associated with the FIQR total score (R(2)=.88; both P.005). The group with the highest global fitness profile had 16% lower FM severity than did the group with the lowest global fitness profile (P.001).Our results suggest that higher physical fitness is consistently associated with lower FM severity in women with FM. Aerobic fitness and flexibility present independent associations with FM severity. However, the FIQR variability explained by these fitness tests was rather low (10%), and further research on the potential disagreement between performance-based physical fitness and different self-reported outcomes in women with FM is warranted.

OBJECTIVES: To compare the 28-joint Disease Activity Score (DAS28) and its components in patients with rheumatoid arthritis (RA) with and without concomitant fibromyalgia (FM), and to investigate the use of biological treatment in the two groups.METHOD: Questionnaires developed to diagnose FM were handed out among RA patients during their planned visits. Values for DAS28 were obtained from the DANBIO registry. Demographic data and data on patients' medical treatment, disease duration, serological and radiological status were retrieved from patients' files. The χ(2) test and an unpaired t-test were applied to investigate group differences in the use of biological therapy, baseline characteristics, patient-reported outcomes, and DAS28 between groups when appropriate.RESULTS: Questionnaires were completed by 162 out of 264 (61%) patients. Twenty-five patients (15.4%) with concomitant FM were identified. No group differences were found regarding disease duration, age, gender, and serological status. Of the RA patients with concomitant FM, 64% were treated with biological therapy vs. 32% of RA patients without concomitant FM (p = 0.002). The mean DAS28 in the FM group was 4.4 compared to 2.9 in the non-FM group (p < 0.001). Elevated DAS28 in the FM group resulted from a high tender joint count (p = 0.003) and a high visual analogue scale (VAS)-global score (p < 0.001). Erosions were more frequent in the non-FM group (p = 0.04).CONCLUSIONS: Concomitant FM in patients with RA is associated with a higher DAS28 due to subjective parameters and with the more frequent use of biological treatments. This raises the question of whether the more frequent use of biologics in these patients is justified by inflammation, or is instead due to persistent pain and other centrally mediated symptoms.

PURPOSE: This study examined the associations of different levels of depression with pain, sleep quality, fatigue, functional exercise capacity, overall fibromyalgia (FM) severity, and health-related quality of life (HRQoL) in women with FM. METHODS: A total of 451 women with FM participated in this cross-sectional study. Depressive symptoms (Beck Depression Inventory; BDI-II), pain intensity (numerical rating scale; NRS), pain sensitivity (algometry), sleep quality (Pittsburgh Sleep Quality Index), fatigue (Multidimensional Fatigue Inventory), functional exercise capacity (6-min walk test), FM severity (revised Fibromyalgia Impact Questionnaire), and HRQoL (SF-36) were assessed. RESULTS: Participants with severe depressive symptoms had significantly higher pain intensity (NRS = 1.1; 95 % CI 0.3-1.8), fatigue (12.6-units; 95 % CI 8.2-17.1) and overall FM severity (12.6-units; 95 % CI 11.4-23.7), as well as poorer sleep quality (3.2-units; 95 % CI 1.7-4.7) and mental component of HRQoL (-17.0-units; 95 % CI -21.0 to -12.9) than participants with minimal signs of depression. There was no association of signs of depression with pain sensitivity, exercise capacity, or the physical component of HRQoL (P > 0.05). CONCLUSIONS: These results extend current knowledge on the association of signs of depression with FM severity and quality of life in women with FM, and suggest that severity of depressive symptoms could potentially be a prognostic factor to be considered in future prospective intervention studies.

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.

OBJECTIVE: To examine the hypothesis that change in pain self-efficacy is associated with observed and self-reported activity, pain intensity, catastrophizing, and quality of life after multi-disciplinary rehabilitation of fibromyalgia patients.DESIGN: In-depth analyses of secondary outcomes of a randomized-controlled trial.SUBJECTS: Women (N = 187) with fibromyalgia.METHODS: Outcomes were Pain Self-Efficacy, Assessment of Motor and Process Skills (AMPS), SF-36 Physical Function (SF-36-PF), pain intensity, and SF-36 Mental Composite Score (SF-36-MCS) to assess quality of life and pain catastrophizing. Individual and group associations between outcomes were examined.RESULTS: Individual changes in pain self-efficacy were not associated with changes in observed activity: AMPS motor (r s = 0.08, p = 0.27) and process (r s = 0.12, p = 0.11), not even in those patients with a clinically relevant improvement in observed functioning (38.5%), and only weakly or moderatly with changes in SF-36-PF; (r s = 0.31, p CONCLUSION: The main hypothesis was falsified, as there was no association between pain self-efficacy and actual performance of activity. The relation to functioning may be limited to perceived, cognitive-emotional aspects, as indicated by the weak to moderate correlations to the self-reported measures. Implications for Rehabilitation Improvement in observed activity post multi-disciplinary rehabilitation was not associated with change in pain self-efficacy. Patients performed better after rehabilitation, but did not perceive to have improved their capacity. The relationship between pain self-efficacy and functioning may be limited to cognitive-emotional aspects rather than actual activity. Both observational and self-reported measures should be included in evaluating outcomes of rehabilitation for patients with fibromyalgia.

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

The aim of this study was to translate, culturally adapt and evaluate the psychometric properties of the Pain Self-Efficacy Questionnaire (PSEQ) in a population of patients with fibromyalgia in Denmark. The study sample included 102 patients diagnosed with fibromyalgia referred to a specialist clinic. The PSEQ was translated and adapted to a Danish setting using a standard stepw-ise forward-backward translation procedure, followed by initial testing and focus group interview. Reliability was examined by analysing internal consistency and test-retest agreement. Construct validity was exami-ned by investigating dimensionality, targeting, local independence, category functioning and differential item functioning (DIF). Reliability was high: Cronbach's alpha 0.88, test-retest correlation 0.93, intraclass correlation coefficient (ICC) 0.89 and item-total correlations 0.44-0.70. Factor analyses and item response (IRT) models indicated unidimensionality, and the PSEQ-DK was well targeted to the sample. High interitem correlation was observed between two items, indicating local dependence, and item misfit and DIF were observed for a few items. However, the overall fit of the scale to a single-factor model and IRT models supported acceptable construct validity. The PSEQ-DK showed acceptable psychometric properties and can therefore represent a reliable and valid measure for evaluating self-efficacy in patients with fibromyalgia in Denmark.

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.

Functional ability, including the ability to perform activities of daily living (ADL), is considered a core outcome domain in chronic pain clinical trials and is usually assessed through generic or disease-specific self-report questionnaires. Research, however, indicates that self-report and performance-based assessment of ADL offer distinct but complementary information about ability. The present study, therefore, investigated the applicability of a performance-based measure of ADL ability, the Assessment of Motor and Process Skills (AMPS), among 50 women with chronic widespread pain. The investigated psychometric properties of the AMPS included discrimination between a sample of healthy women and those with chronic widespread pain, as well as stability when no intervention was provided and sensitivity to change following intervention. Data were obtained based on a repeated measures design performing AMPS evaluations twice pre- and twice post-rehabilitation. Results indicated that the ADL motor ability measures of the participants were significantly lower than those of healthy women of same age, the ADL motor and ADL process ability measures remained stable when no intervention was provided and the ADL motor ability measures were sensitive to change following a 2-week interdisciplinary rehabilitation program. A weak correlation ( r s = −0.35) was found between self-reported ADL ability as measured by the physical function subscale of the Functional Impact Questionnaire (FIQ) and performance-based ADL motor measures, and no correlation ( r s = −0.02) was found between FIQ ADL measures and ADL process ability, supporting the need for both performance-based and self-reported assessment of ADL.

In all, 19-22% of the adult Danish population suffer from chronic pain - most frequently in the musculoskeletal system. Different pain management strategies depending on pain mechanism (neuropathic/nociceptive) make diagnosing the pain condition especially important.To investigate whether a validated, self-administered questionnaire (PainDETECT) helps specialists and general practitioners in Denmark identify patients with neuropathic pain components (NeP).In a non-interventional study a sample of Danish specialists (rheumatologists and anaesthesiologists) and general practitioners used the PainDETECT questionnaire on 1322 chronic pain patients. PainDETECT was filled in by patients and scored by the physician. A PainDETECT score above 18 indicates the presence of NeP.A total of 87-95% of the included chronic pain patients (702 by specialists (mean age: 56 years) and 620 by general practitioners (mean age: 55 years)) had musculoskeletal pain. In 39-43% of these patients NeP components were present as assessed by PainDETECT (score 21.1-21.7). One-third of the 540 NeP patients (31-36%) had their pain diagnosis reclassified from a non-NeP to a predominant/mixed NeP diagnosis after use of PainDETECT.Neuropathic pain seems to be underdiagnosed in musculoskeletal pain conditions. Use of the PainDETECT instrument may be of help to general practitioners and specialists when diagnosing NeP in chronic pain patients. However, the fact that no neurologists were included, together with the limited sample size, with large variations in the number of patients each physician included, as well as the lack of a strict consecutive recruitment process are study limitations.

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.

To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearmans correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants.

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.

This study examined the functional and psychological outcomes of a 2-week, group-based multicomponent treatment course that targeted patients with chronic widespread pain. Patients (192 included in the intention-to-treat population), all fulfilling the 1990 American College of Rheumatology classification criteria for fibromyalgia, were consecutively recruited from a tertiary care setting and randomized (1:1) to either the treatment course or a waiting list control group. Co-primary outcomes were the Assessment of Motor and Process Skills (AMPS) and SF-36 Mental Composite Score (MCS) evaluated at 6-month follow-up. Primary endpoints were partly achieved with a statistically significant improvement in AMPS activities of daily living motor (group mean difference: 0.20 [95% confidence interval (CI): 0.09 to 0.31] logits; P =.0003) and AMPS activities of daily living process (0.20 [95% CI: 0.12 to 0.27] logits, P

Emerging evidence suggests that pain might be more effectively classified and treated according to the mechanisms underlying the onset and/or the maintenance of pain. Multiple mechanisms that can produce pain have been identified, including tissue injury and inflammation (inflammatory pain), damage to the nervous system (neuropathic pain), and abnormal responsiveness or function of the central nervous system (central sensitization, dysfunction of descending pain modulating systems). Central pain mechanisms may play an important role in rheumatic diseases, traditionally considered peripheral inflammatory entities. Inflammation sensitizes polymodal nociceptors. This peripheral sensitization induces hyperexcitability of nociceptive neurons in the central nervous system (central sensitization) and the two together generate the features of pathological pain, allodynia and hyperalgesia, confined to the inflamed tissues. Increased responsiveness of peripheral and central neurons (pain hypersensitivity) in the presence of tissue injury and inflammation is a normal response (neuroplasticity). As a rule, these sensitization phenomena extinguish themselves as the tissue heals and inflammation subsides. However, persistent pain is common in patients with inflammatory joint disorders and the key question is whether these neuroplastic changes persists in subsets of patients and leads to chronic pain states in which pain is no longer coupled to the presence of ongoing peripheral inflammation. If central pain mechanisms do play a significant role in pain processing and persistence of pain in subgroups of patients, strategies for managing pain in addition to inflammatory disease suppression may be required. Furthermore, in these patients, persistent pain hypersensitivity may lead to continuous high reports of tender joints and poor global health and pain leaving the physician with the clinical dilemma that patient reported outcomes and composite disease activity scores do not correspond to the objective level of inflammatory activity. Simple methods assisting identification of underlying pain mechanisms in the clinical care of rheumatologic patients are therefore needed. The painDETECT Questionnaire (PDQ) is a patient administered screening questionnaire originally developed to determine the likelihood of a predominant neuropathic pain component being present. The questionnaire comprises 7 weighted somatosensory symptom and sign items and 2 items relating to the spatial (radiating) and temporal characteristics of the individual pain pattern. Although developed as a screening questionnaire for neuropathic pain, the PDQ has increasingly been used to assess neuropathic pain features as a proxy of central pain mechanisms in, for example, patients with osteoarthritis and fibromyalgia. Recently, the PDQ has also been introduced in studies assessing pain mechanisms in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA). The clinical utility of the PDQ in patients with arthritis will be covered based on patient cases, registry data and clinical studies. The prevalence and description of PDQ-derived pain phenotypes and the prognostic value thereof will be discussed. Disclosure of Interest None declared

Background Functional ability, which includes the ability to perform activities of daily living (ADL), is considered a core outcome domain in rheumatology. Recommendations for assessing ADL ability include the use of generic and diseases-specific questionnaires based on self-report and one of the most frequently used instruments is the Health Assessment Questionnaire Disability Index (HAQ-DI). Self-report reflects the person9s perception of extent of disability, which may be influenced by pain and other psychosocial factors. A poor agreement between self-reported and observed ADL ability has previously been demonstrated in rheumatic populations based on other self-report instruments. Objectives to evaluate relationships between HAQ-DI scores and measures of observed ADL ability in patients with inflammatory and non-inflammatory rheumatic diseases and the association between pain and fatigue and these disability measures. Methods patients with rheumatoid arthritis (RA), knee osteoarthritis (OA) and fibromyalgia (FM) were assessed with the HAQ-DI. The Assessment of Motor and Process Skills (AMPS) was used to obtain measures of observed ADL ability. Two domains of observed ADL ability were evaluated: ADL motor skills (moving self and objects) and ADL process skills (organizing and adapting actions). Pain and fatigue were assessed by 100mm visual analogue scales (VAS). The project was approved by the local ethical committee (H-B-2007–084). Results 143 women (50 with RA, 27 with knee OA, 66 with FM), mean age 51.2 (11.8) participated. Baseline characteristics and correlations are presented in table 1. Patients with FM had the highest pain, fatigue, and HAQ disability scores and the poorest performance on the AMPS. The relationships between self-reported and observed ADL motor ability were weak to moderate across all diagnostic groups; strongest in patients with knee OA. Relationships with the AMPS ADL process ability measure were weak to insignificant. Level of pain, and not fatigue, showed the strongest relationship with self-reported functional ability across all diagnostic groups. A weak to moderate relationship between pain and AMPS ADL motor ability measures were also present in patients with RA and OA, but insignificant in patients with FM (r= -0.16, p=0.195). Conclusions the relation between self-reported and observed functional ability is low across a spectrum of musculoskeletal diagnoses, even when using instruments recommended for these populations including the HAQ-DI. This has major implications on how to interpret and measure functional ability in the future as both methods should probably accompany each other. Interestingly pain was not associated with observed motor ADL ability in FM as opposed to RA and OA. Disclosure of Interest None declared

Background Pain in rheumatoid arthritis (RA) is typically regarded as related to on-going synovial inflammation in peripheral joints. However, in a subgroup of patients evidence indicates that pain can become an entity of its own caused by central sensitization (CS), elicited by but in time not directly related to ongoing inflammation. The painDETECT questionnaire (PDQ) was developed to differentiate neuropathic pain from unclear and non-neuropathic pain. In several studies it has been used to indicate CS owing to similarities in somatosensory profiles. Magnetic resonance imaging (MRI) can be used as an objective inflammation marker, quantified by the RA MRI Score (RAMRIS). Objectives To evaluate the prognostic value of a PDQ score >18 on DAS28 response in RA patients taking a possible interaction with inflammation defined by RAMRIS synovitis scores into account. Methods RA patients were included when they were to: 1) initiate a disease modifying antirheumatic drug (DMARD) or 2) initiate or switch a biological agent. At baseline and after 4 month of follow up patients went through an examination program incl. standard demographics, clinical examination, hand MRI, patient reported outcomes (incl. PDQ), and blood samples. Least-Squares Mean change (95% CI) was calculated using ANCOVA adjusting for the value at baseline. Multivariable regressions with DAS28 or RAMRIS synovitis change as outcome were performed to determine the prognostic variables. The model included PDQ-category, RAMRIS synovitis score and their interaction. Possible confounders were: gender, disease duration, baseline DAS28, and initiation group. PDQ score was interpreted as: >18 indication of CS, 13–18 unclear pain mechanism, Results 102 patients were included, 75 had an MRI scan performed. Mean changes stratified by PDQ-group are presented in the table showing the greatest changes in the CS-group (>18). Only baseline DAS28 was a significant predictor of DAS28 change (P 18) at baseline all had changed classification-group at follow-up (8 to nociceptive pain and 4 to unclear). Conclusions In this pragmatically sampled population of RA patients, pain classification by PDQ at treatment initiation had no prognostic value with regard to change in DAS28 or RAMRIS synovitis. In contrast, all patients classified with indication of CS by PDQ at baseline changed classification group and were even to gain most from treatment start in net changes. This might indicate that in RA, CS reflects normal neuroplasticity that is reversible with reduction of inflammation. References Koroschetz J, et al. Fibromyalgia and neuropathic pain-differences and similarities. A comparison of 3057 patients with diabetic painful neuropathy and fibromyalgia. BMC Neurol 2011;11:55 Disclosure of Interest None declared

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.

ObjectiveTo investigate relationships between perceived and objectively measured muscle fatigue during exhausting muscle contractions in women with fibromyalgia (FM) compared with healthy controls (HC).MethodsWomen with FM and HC completed an isometric muscle exhaustion task at 90° shoulder abduction. Surface electromyographic (EMG) activity in the deltoid muscle was recorded together with self-reported level of muscle fatigue.Results25 participants with FM and 23 HC were included. Average time to exhaustion was 254 s shorter in participants with FM than in HC. Participants with FM did not exhibit the same level of objective signs of muscle fatigue, seen as fewer changes in the EMG activity, as the HC during the exhaustion task. The task did not provoke pain in the HC, while participants with FM reported a doubling of pain.ConclusionsWomen with FM had shorter exhaustion times and showed fewer objective signs of muscle fatigue during an exhausting isometric shoulder abduction compared with younger HC. This indicates that perceived muscle fatigue may be of central origin and supports the notion of central nervous dysfunction as basic pathological changes in FM.

Knowledge about functional ability, including activities of daily living (ADL), in patients with chronic widespread pain (CWP) and fibromyalgia (FMS) is largely based on self-report. The purpose of this study was to assess functional ability by using standardised, observation-based assessment of ADL performance and to examine the relationship between self-reported and observation-based measures of disability. A total of 257 women with CWP, 199 (77%) fulfilling the American College of Rheumatology tender point criteria for FMS, were evaluated with the Assessment of Motor and Process Skills (AMPS), an observation-based assessment providing linear measures of ADL motor and ADL process skill ability (unit: logits). A cutoff for effortless and independent ADL task performance is set at 2.0 for the motor scale and 1.0 for the process scale. A total of 248 (96.5%) had ability measures below the 2.00 ADL motor cutoff and 107 (41.6%) below the 1.00 ADL process cutoff, indicating increased effort and/or inefficiency during task performance as well as a potential need of assistance for community living. Mean ADL motor ability measure was 1.07 and was significantly lower in patients diagnosed with FMS than plain CWP (1.02 vs 1.27 logits, P = .001). Mean ADL process ability measure was 1.09 logits and was without difference between FMS and plain CWP (1.07 vs 1.16 logits, P = .064). Only weak to moderate correlations between self-reported functional ability and observation-based AMPS ability measures were observed. The results of the study support the notion of considerable performance difficulties in women with CWP. The everyday life problems are substantial and place the individual at risk of need of support for community living.

Widespread pain and pain hypersensitivity are the hallmark of fibromyalgia, a complex pain condition linked to central sensitization. In this study the painDETECT questionnaire (PDQ), validated to identify neuropathic pain and based on pain quality items, was applied in a cross-sectional sample of patients with chronic widespread pain (CWP). The aims of the study were to assess the patient-reported sensory neuropathic symptoms by PDQ and to correlate these with tender point (TP) count and pressure-pain thresholds. Eighty-one patients (75 F, 6 M) with CWP (ACR-criteria) filled in the PDQ. Manual TP examination was conducted according to ACR guidelines. Computerized cuff pressure algometry was used for the assessment of pressure-pain detection thresholds (PDT, unit: kPa) and pressure-pain tolerance thresholds (PTT, unit: kPa). Mean TP count was 14.32 (range: 2–18), mean PDQ score 22.75 (range: 5–37). Mean PDT was 8.8 kPa (range: 2–36) and mean PTT 30.9 kPa (range: 4–85). Deep-tissue hyperalgesia was the predominant somatosensory symptom reported in 83%, but other neuropathic symptoms were also frequent, e.g. burning 51% and prickling 47%. Statistically significant correlations were found between PDQ score and TP count: r = 0.35 (p < 0.01), and PDQ score and PDT: r = 0.45 (p < 0.01), and PTT: r = 0.43 (p < 0.01). The study indicates that pain in CWP has neuropathic features, and that the presence and number of tender points are associated with neuropathic pain symptoms. A high mean PDQ score was found to correlate with TP count and pressure-pain thresholds. The PDQ may become a useful tool assisting in the identification of central sensitization in patients with CWP and in the future diagnostic assessment fibromyalgia.

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. Method 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. Results 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. Conclusion 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.

Background Central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The validated painDETECT Questionnaire (PDQ) was developed to detect neuropathic pain by assigning a score to the patient. Numerous studies in osteoarthritis and fibromyalgia have used the PDQ to assess central sensitization linking the pain phenotypic similarities of neuropathic pain and central sensitization together. Data are emerging within RA and SpA. Objectives Based on PDQ classification, to identify pain phenotypes (nociceptive vs. central mechanisms) in Danish patients with inflammatory arthritis; to determine prevalence and assess association to present inflammation. Further to characterize the different pain populations. Methods An electronic version of the PDQ was included onto the DANBIO touch screens in the waiting rooms at 22 of 24 departments of Rheumatology in Denmark for six months. Patients diagnosed with RA, PsA or SpA were invited to participate. Consent was obtained. Patients who declined participation were asked, whether it was due to being pain-free. Corresponding clinical data and patient reported outcomes (PROs) were obtained from DANBIO. A PDQ score >18 was interpreted as an indication of predominant central pain mechanisms, 13-18 as unclear and Kruskal-Wallis test, Chi square test and Spearman (Rho) correlations between PDQ score and selected variables were performed. Results Of 15978 invited patients, 52% had a VAS pain ≥30mm. A total of 1927 patients were pain-free, 7918 patients agreed to fill in the PDQ and 7054 completed it (RA: 3826, PsA: 1180, SpA: 1093, unspecified: 955). VAS pain ≥30mm was present in 59.5%/ 67%/ 67% of RA/ PsA/ SpA pts. Prevalence 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 Conclusions In a cohort of >7000 arthritis patients, pain was present in $≈ $50% of the patients across diagnoses. More than 20% had indication of central sensitization (PDQ score >18). The PDQ score was associated with DAS28 and PROs but not with markers of peripheral inflammation (CRP and swollen joint count). Thus, pain classification by PDQ may assist in identifying patients with predominant central sensitization and promote a pain mechanism based treatment approach. References Koroschetz J, Rehm SE, Gockel U, et al. Fibromyalgia and neuropathic pain-differences and similarities. A comparison of 3057 patients with diabetic painful neuropathy and fibromyalgia. BMC Neurol 2011;11:55 Acknowledgements The authors wish to thank all participating Departments of Rheumatology, DANBIO and Zitelab. Furthermore, The Oak Foundation and Selsbjerg Holding for financial support. Disclosure of Interest None declared

Background 10-20% of patients with rheumatoid arthritis (RA) display features of central sensitization. The numbers are less well documented within psoriatic arthritis (PsA) and other spondyloarthritis (SpA). There is a need for instruments that can be used to identify underlying pain mechanism. The painDETECT Questionnaire (PDQ) was originally developed and validated to classify pain into unlikely ( 18 points). Current evidence suggests that the PDQ may also assist identification of pain that is primarily driven by central mechanisms. Objectives To evaluate the psychometric properties of the painDETECT Questionnaire (PDQ) when used to classify pain in inflammatory arthritis by applying Rasch analysis and to explore the reliability of pain classification. Methods For the Rasch analysis 306 (102x3) questionnaires from patients with RA, PsA or other SpA were extracted from “the DANBIO painDETECT study” (cross sectional registry survey N=7918, not published). The analysis was directed at the seven items assessing somatosensory symptoms. Three points were addressed: 1) the performance of the six-category Likert scale (Partial Credit Model); 2) whether a unidimensional construct was defined; and 3) the reliability and precision of estimates. The Rasch computer program WINSTEPS 3.68.2 was used. Another group of 30 patients diagnosed with RA, PsA or other SpA participated in a test-retest study. Re-test took place within two-four days. Intraclass Correlation Coefficients (ICC) and classification consistency were calculated. Results Rasch analysis: (1) acceptable psychometric properties of the rating scale; the frequency distribution peaked in category 0 except for item 5. Threshold calibration >10 observations per category except for category 5 in items 2, 3 and 4. No disorder in the category measures for all items. Scale category outfit; Mnsq Test-retest: ICC: RA 0.86 (0.56-0.96), PsA 0.96 (0.74-0.99), SpA 0.93 (0.76-98), in total 0.94 (0.84-0.98). Classification consistency was: RA 70%, PsA 80%, SpA 90%, in total 80%. Conclusions The results support the use of the PDQ in future research of mechanism-based pain classification in inflammatory arthritis. In clinical care, the PDQ may serve as an easily applied screening tool assisting identification of individuals with pain suspected not to originate from peripheral mechanisms of nociception and inflammation. References Freynhagen R et al. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin 2006 Oct;22(10):1911-20. Koroschetz J et al. Fibromyalgia and neuropathic pain-differences and similarities. A comparison of 3057 patients with diabetic painful neuropathy and fibromyalgia. BMC Neurol 2011;11:55 Acknowledgements The authors wish to thank all participating Departments of Rheumatology and DANBIO. Furthermore, The Oak Foundation and Selsbjerg Holding for financial support. Disclosure of Interest None declared

Background Randomised trials that have tested targeted therapies (targeted synthetic disease modifying antirheumatic drugs, tsDMARDs and biological disease modifying antirheumatic drugs, bDMARDs) for rheumatoid arthritis (RA) vary in several of their trial and participant characteristics [1], but little is known about whether these characteristics influence the overall effect of the therapies in the reported trials. Objectives To determine whether trial and participant characteristics modify the treatment response when testing the efficacy of targeted therapies (in contrast to comparator) for RA. Methods We conducted a meta-epidemiological study of all trials testing a dosage of a targeted therapy approved by regulatory authorities for the treatment of RA. Included trials reported ACR20 data at months 3-6 and used an add-on design. Anakinra and open-label trials were not included. Odds ratios (ORs) were calculated from the response rates and compared among the trial/participant characteristics of interest. Statistical analyses were performed using SAS v 9.3 (REML based models). Comparisons between strata 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 as the outcome (table 1). Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval 3.41 to 4.60). The net benefit of targeted therapies was lower in trials including “DMARD-naive” patients compared with both “DMARD inadequate responders” (ROR=0.45, 0.31 to 0.66) and “biologic inadequate responders” (0.50, 0.29 to 0.87) trials (test for interaction: p=0.0002). Longer disease duration of the trial population was also statistically significantly associated with a higher likelihood of responding to treatment (β=1.05, 1.00 to 1.11 OR9s per year). Analyses conducted using DAS28-remission as the outcome supported the above-mentioned findings. Conclusions Trial evidence suggests that using targeted therapies add the greatest net benefit in patients who are inadequate responders to previous DMARDs or biological agents, and trials including patients with longer disease duration. These findings justify that all RA patients should be exposed to DMARD treatment before introduction of a bDMARD is considered. References Rahman MU, Buchanan J, Doyle MK, et al. Changes in patient characteristics in anti-tumour necrosis factor clinical trials for rheumatoid arthritis: results of an analysis of the literature over the past 16 years. Ann Rheum Dis 2011 Sep;70(9):1631-40. Acknowledgements This study is supported financially by The Oak Foundation, Selsbjerg Holding and Region Hovedstadens Forskningsfond. Disclosure of Interest None declared