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Objective: This study aimed to explore whether phenotypic characteristics of patients with chronic widespread pain (CWP) and fibromyalgia (FM) can be aggregated into definable clusters that may help to tailor treatments. Method: Baseline variables (sex, age, education, marital/employment status, pain duration, prior CWP/FM diagnosis, concomitant rheumatic disease, analgesics, tender point count, and disease variables derived from standardized questionnaires) collected from 1099 patients (93.4% females, mean age 44.6 years) with a confirmed CWP or FM diagnosis were evaluated by hierarchical cluster analysis. The number of clusters was based on coefficients in the agglomeration schedule, supported by dendrograms and silhouette plots. Simple and multiple regression analyses using all variables as independent predictors were used to assess the likelihood of cluster assignment, reported as odds ratios (ORs) with 95% confidence intervals (CIs). Results: Only one cluster emerged (Cluster 1: 455 patients). Participants in this cluster were characterized as working (OR 66.67, 95% CI 7.14 to 500.00), with a medium-term/higher education (OR 16.80, 95% CI 1.94 to 145.41), married/cohabiting (OR 14.29, 95% CI 1.26 to 166.67), and using mild analgesics (OR 25.64, 95% CI 0.58 to > 999.99). The odds of being an individual in Cluster 1 were lower when having a worse score on the PDQ (score ≥ 18) (OR < 0.001, 95% CI < 0.001 to 0.02). Conclusion: We identified one cluster, where participants were characterized by a potentially favourable clinical profile. More studies are needed to evaluate whether these characteristics could be used to guide the management of patients with CWP and FM. [ABSTRACT FROM AUTHOR]

Patient education is recommended as an integral component of the therapeutic plan for the management of chronic widespread pain (CWP) and fibromyalgia (FM). The key purpose of patient education is to increase the patient's competence to manage his or her own health requirements, encouraging self-management and a return to desired everyday activities and lifestyle. The aim of this systematic review was to evaluate the evidence for the benefits and potential harms associated with the use of patient education as a stand-alone intervention for individuals with CWP and FM through randomized controlled trials (RCTs). On 24 November 2021 a systematic search of PubMed, MEDLINE, Embase, CENTRAL, PsycINFO, CINAHL, ClinicalTrials.gov, American College of Rheumatology, European League Against Rheumatism, and the World Health Organization International Clinical Trials Registry Platform identified 2069 studies. After full-text screening, five RCT studies were found to be eligible for the qualitative evidence synthesis. Patient education as a stand-alone intervention presented an improvement in patients' global assessment (standardized mean difference 0.79, 95% confidence interval 0.13 to 1.46). When comparing patient education with usual care, no intervention, or waiting list, no differences were found for functioning, level of pain, emotional distress in regard to anxiety and depression, or pain cognition. This review reveals the need for RCTs investigating patient education as a stand-alone intervention for patients with FM, measuring outcomes such as disease acceptance, health-related quality of life, enhancement of patients' knowledge of pain, pain coping skills, and evaluation of prioritized learning outcomes. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the psychometric properties of the Danish version of the Fibromyalgia Impact Questionnaire – Revised (FIQR), when used to quantify the severity of disease burden in a Danish population of patients with chronic widespread pain (CWP), including fibromyalgia (FM). A total of 924 participants diagnosed with CWP and/or FM completed an electronic version of the FIQR via touchscreens in the clinic at referral for specialist care. Data were collected from 1 January 2018 to 3 September 2020. Rasch measurement methods were applied. Rating scale analysis suggested multiple threshold disordering in the 0–10 category rating scale. A principal component analysis suggested assessment of a multidimensional construct. Thus, the Rasch analysis of the full FIQR was discontinued. Instead, Rasch analyses were performed on the two subscales: 'function' and 'symptoms'. By collapsing the rating scale to a 0–4 category scale, the remaining threshold disordering of both subscale was solved. Only the symptom subscale indicated multidimensionality. There was underfitting misfit of item 21 and overfitting misfit of item 12. No significant differential item functioning, defined by sex, ethnicity, or education, was found. The FIQR should be considered as an instrument consisting of three separate subscales representing 'function', 'overall impact', and 'symptoms'. We recommend calculating and reporting on both a 0–10 and a 0–4 category scale. Also, if using the total FIQR score as an outcome measure, this should be done with caution, until revision of the rating scale. [ABSTRACT FROM AUTHOR]

To compare the effect of treat-to-target-based escalations in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biologics on clinical disease activity and magnetic resonance imaging (MRI) inflammation in a rheumatoid arthritis (RA) cohort in clinical remission. One-hundred patients with established RA, Disease Activity Score based on 28-joint count–C-reactive protein (DAS28-CRP) < 3.2, and no swollen joints (hereafter referred to as 'in clinical remission') who received csDMARDs underwent clinical evaluation and MRI of the wrist and second to fifth metacarpophalangeal joints every 4 months. They followed a 2 year MRI treatment strategy targeting DAS28-CRP ≤ 3.2, no swollen joints, and absence of MRI osteitis, with predefined algorithmic treatment escalation: first: increase in csDMARDs; second: adding a biologic; third: switch biologic. MRI osteitis and Health Assessment Questionnaire (HAQ) (co-primary outcomes) and MRI combined inflammation and Simplified Disease Activity Index (SDAI) (key secondary outcomes) were assessed 4 months after treatment change and expressed as estimates of group differences. Statistical analyses were based on the intention-to-treat population analysed using repeated-measures mixed models. Escalation to first biologic compared to csDMARD escalation more effectively reduced MRI osteitis (difference between least squares means 1.8, 95% confidence interval 1.0–2.6), HAQ score (0.08, 0.03–0.1), MRI combined inflammation (2.5, 0.9–4.1), and SDAI scores (2.7, 1.9–3.5). Treat-to-target-based treatment escalations to biologics compared to escalation in csDMARDs more effectively improved MRI inflammation, physical function, and clinical disease activity in patients with established RA in clinical remission. Treatment escalation in RA patients in clinical remission reduces clinical and MRI-assessed disease activity. Clinicaltrials.gov identifier: NCT01656278 [ABSTRACT FROM AUTHOR]

Objective: The aim was to explore dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) as an early marker of therapeutic response in patients with rheumatoid arthritis (RA) starting treatment with certolizumab pegol (CZP).Method: In 40 RA patients initiating CZP (27 patients) or 2 weeks of placebo (PCB) followed by CZP (13 patients), DCE-MRI of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints was performed at weeks 0, 1, 2, 4, 8, and 16. Using semi-automated software, three methods for drawing volume regions of interest (ROIs) in MCP2-5 and PIP2-5 were applied: 'Standard' (slices: all; joints: MCP2-5 together and PIP2-5 together), 'Detailed' (slices: slices with high-quality visualization; joints: as Standard), and 'Single-joint' (slices: as Detailed; joints: each joint separately). The number of enhancing voxels (Nvoxel), initial rate of enhancement (IRE), and maximum enhancement (ME) were extracted and analysed for each method.Results: Nvoxel in MCP2-5, and IRE and ME in PIP2-5 decreased statistically significantly (Wilcoxon rank-sum test, p < 0.02-0.03) after 16 weeks of treatment for the Standard method. Nvoxel and ME decreased significantly more in the CZP group than in the PCB group after 1 week of treatment, but not at later time-points. There were no significant changes for DCE-MRI parameters for the Detailed and Single-joint methods.Conclusions: Certain DCE-MRI parameters detected decreased inflammation during CZP treatment in RA patients. Using specific criteria for ROIs, as in the Detailed and Single-joint methods, decreased the statistical power and could not show any changes over time. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 instrument's 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. [ABSTRACT FROM AUTHOR]

Objectives: 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 Spearman's 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. [ABSTRACT FROM AUTHOR]

Objectives: To identify the magnetic resonance imaging (MRI) parameter that best differentiates healthy persons and patients with early rheumatoid arthritis (RA), and to investigated responsiveness to treatment of various MRI parameters. Method: Conventional MRI and dynamic contrast-enhanced (DCE)-MRI of the hand were performed once for 26 healthy persons, and before and after 6 and 12 months of disease-modifying anti-rheumatic drug (DMARD) treatment for 14 early RA patients, using a 1.0-T MRI unit. One-slice DCE-MRI was analysed using Dynamika version 4.2. The number of enhancing voxels (Nvoxel), the initial rate of enhancement (IRE), the maximum enhancement (ME), ME×Nvoxel, and IRE×Nvoxel were calculated for wrist and 2nd-5th metacarpophalangeal (MCP) joints. Conventional MR images were evaluated using the RA MRI scoring system (RAMRIS) synovitis score. Results: Using DCE-MRI, enhancement was demonstrated in 61.5% of healthy persons and in 91.7% of RA patients at baseline, with a median Nvoxel of 3 and 362, respectively. At baseline, all parameters were higher for patients than for healthy persons (all p ≤ 0.003). Only one patient had a baseline RAMRIS synovitis score below the 95th percentile of the healthy persons. The corresponding number of patients was 3 for Nvoxel, ME×Nvoxel and IRE×Nvoxel, and 10 for IRE and ME. The RAMRIS synovitis score and IRE showed the highest responsiveness, with a standardized response mean (SRM) of -1.00 and -0.88, respectively. Conclusions: The RAMRIS synovitis scoring of conventional MRI, and to a lesser extent the one-slice DCE-MRI parameters of synovial volume, differentiated early RA patients and healthy persons. The decrease in RAMRIS synovitis score, Nvoxel, and IRE showed sensitivity to change during treatment. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the responsiveness to treatment and the reliability of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in rheumatoid arthritis (RA) knee joints. Methods: DCE-MRI was performed in 12 clinically active RA knee joints before and 1, 7, 30, and 180 days after intra-articular injection with 80 mg methylprednisolone. Using semi-automated image processing software, DCE-MRI parameters, including the initial rate of enhancement (IRE) and maximal enhancement (ME), were generated for three regions of interest (ROIs): 'Whole slice', 'Quick ROI', and 'Precise ROI'. The smallest detectable difference (SDD), the smallest detectable change (SDC), and intra- and inter-reader intraclass correlation coefficients (ICCs) were used to assess the reliability of DCE-MRI. Responsiveness to treatment was assessed by the standardized response mean (SRM). Results: In all patients clinical remission of the knee was achieved at day 7. All DCE-MRI parameters decreased from day 0 to day 7. Using the Quick and Precise ROI methods, respectively, IRE decreased by 63% and 69%, ME decreased by 11% and 11%, Nvoxel decreased by 55% and 57%, and IRE × Nvoxel decreased by 84% and 85%. The intra- and inter-reader ICCs were very high (0.96-1.00). The decrease in DCE-MRI parameters was larger than the SDC for all patients. SRM was large for all parameters, ranging from -1.04 to -2.40. When the Whole slice ROI method was used, no parameters were responsive to treatment. Conclusions: DCE-MRI analysed using semi-automatic software is a reliable and responsive tool for assessing treatment in RA knees joints. Rough manual delineation of the joint to omit enhancement artefacts is necessary. [ABSTRACT FROM AUTHOR]

Objective: To determine whether dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) evaluated using semi-automatic image processing software can accurately assess synovial inflammation in rheumatoid arthritis (RA) knee joints. Methods: In 17 RA patients undergoing knee surgery, the average grade of histological synovial inflammation was determined from four biopsies obtained during surgery. A preoperative series of T1-weighted dynamic fast low-angle shot (FLASH) MR images was obtained. Parameters characterizing contrast uptake dynamics, including the initial rate of enhancement (IRE), were generated by the software in three different areas: (I) the entire slice (Whole slice); (II) a manually outlined region of interest (ROI) drawn quickly around the joint, omitting large artefacts such as blood vessels (Quick ROI); and (III) a manually outlined ROI following the synovial capsule of the knee joint (Precise ROI). Intra- and inter-reader agreement was assessed using the intra-class correlation coefficient (ICC). Results: The IRE from the Quick ROI and the Precise ROI revealed high correlations to the grade of histological inflammation (Spearman's correlation coefficient (rho) == 0.70, p == 0.001 and rho == 0.74, p == 0.001, respectively). Intra- and inter-reader ICCs were very high (0.93-1.00). No Whole slice parameters were correlated to histology. Conclusion: DCE-MRI provides fast and accurate assessment of synovial inflammation in RA patients. Manual outlining of the joint to omit large artefacts is necessary. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the number needed to treat (NNT) and the number needed to harm (NNH) of the second-generation biologics abatacept, certolizumab, golimumab, rituximab, and tocilizumab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX). Methods: A systematic literature search of MEDLINE, EMBASE, Web of Science, and the Cochrane Register of Controlled Trials was conducted up to 1 November 2009. We selected any published randomized, double-blind, MTX-controlled study including RA patients with a mean disease duration of at least 5 years before entering a pivotal trial on second-generation biological therapy. Studies eligible for inclusion involved patients, who had previously shown inadequate response to conventional disease-modifying anti-rheumatic drug (DMARD) therapy. Pre-specified binary outcomes were extracted with a preference for 1-year data (6-month data were used if no data were available for 1 year). Two reviewers independently extracted the data necessary to estimate the absolute measures in a non-responder intention-to-treat (ITT) analysis. Results: Five randomized controlled trials, one for each of the drugs, were selected and data extracted according to published data at endpoint for American College of Rheumatology 50% (ACR50)-responding patients, and withdrawals due to adverse events. NNT ranged from four to six treated patients to achieve one ACR50 response, while withdrawals due to adverse events were few and non-significant compared to the placebo group, except for rituximab administered as 1000 mg. Conclusion: Comparable efficacy was shown by the five biological agents studied, with few adverse events. However, for rituximab, tocilizumab, and golimumab, only 6-month data were available, hampering the external validity with regard to long-term efficacy and tolerability. A low dose (500 mg) of rituximab may be as effective as the recommended dose of 1000 mg. [ABSTRACT FROM AUTHOR]

Objective: The aim of our study was to compare the presence of full-length and alternative splice forms of FoxP3 mRNA in CD4 cells from rheumatoid arthritis (RA) patients and healthy controls. Methods: A quantitative real-time polymerase chain reaction (QRT-PCR) method was used to measure the amount of FoxP3 mRNA full-length and splice forms. CD4-positive T cells were isolated from peripheral blood from 50 RA patients by immunomagnetic separation, and the FoxP3 mRNA expression was compared with the results from 10 healthy controls. Results: We observed an increased expression of full-length FoxP3 mRNA in RA patients when compared to healthy controls, as well as an increase in CD25 mRNA expression, but no corresponding increase in CTLA-4 mRNA expression. The presence of an alternative splice form of FoxP3 lacking exon 2 was confirmed in both RA patients and healthy controls, but with no significant difference in expression between the two groups. There was a positive correlation between the amount of FoxP3 mRNA and the clinical inflammation parameters C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and a negative correlation between FoxP3 mRNA and the dose of methotrexate (MTX) given to the patients. Conclusion: RA patients express more full-length FoxP3 than healthy controls in peripheral blood CD4-positive cells, suggesting an increased number of regulatory T cells (Tregs). However, no concomitant increase in CTLA-4 expression was seen. We therefore propose that the Tregs are left unable to suppress the ongoing inflammation due to a deficiency in CTLA-4 needed for cell contact-dependent suppression. [ABSTRACT FROM AUTHOR]

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. OBJECTIVES: To investigate whether a validated, self-administered questionnaire (PainDETECT) helps specialists and general practitioners in Denmark identify patients with neuropathic pain components (NeP). RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. [ABSTRACT FROM AUTHOR]

Objective: To assess the metabolism of collagen in fibromyalgia (FM) patients, and to compare the occurrence of collagen metabolism markers to the severity of FM symptoms. Methods: Morning urine was collected from 27 FM women fulfilling the American College of Rheumatology (ACR) criteria for FM, and from seven controls. FM patients completed the Fibromyalgia Impact Questionnaire (FIQ). Bone mineral density (BMD), isokinetic muscle strength in knee and elbow, and hand-grip strength were measured. Urinary concentrations of collagen type I cross-linked C-telopeptide (CTX-I) and collagen type II cross-linked C-telopeptide (CTX-II) were determined by enzyme-linked immunosorbent assay (ELISA). Pyridinoline (Pyd) and deoxypyridinoline (Dpd) were determined by liquid chromatography, and hydroxyproline (Hyp) by spectrophotometry. All concentration data were normalized to creatinine. Results: Mean values in the FM group and the control group, respectively, were: urinary CTX-I 246.8 and 337.5 µg/mmol (p = 0.060); CTX-II 110.4 and 185.1 ng/mmol (p = 0.035); Pyd 56.1 and 52.3 nmol/mmol (NS); Dpd 15.1 and 14.0 nmol/mmol (NS); Pyd : Dpd ratio 4.05 and 3.96 (NS); Hyp 26.1 and 21.1 µmol/mmol (NS). Significant inverse correlations were seen between CTX-I and the intensity of fatigue, and between CTX-II and anxiety. An inverse correlation between CTX-I and muscle strength was apparent, but relied on extreme values from one patient, and no significant correlation was found between CTX-I or CTX-II and tender points or BMD in the FM group. Conclusions: Low urinary concentrations of CTX-II and CTX-I and normal levels of Pyd and Dpd were found in FM, but their relationship to the intensity of FM symptoms was unclear. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of adalimumab, etanercept, and infliximab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX) by calculating the number needed to treat (NNT) using three different methods. Methods: A systematic literature search of the Cochrane Library, MEDLINE, and EMBASE was conducted from inception to 30 June 2006. Two pairs of investigators, a Danish and a Swedish pair, independently conducted a structured literature review. The reviewers selected any published randomized, double-blind, MTX controlled study of adalimumab, etanercept, and infliximab, presenting the American College of Rheumatology 50% response (ACR50) after 12 months in RA patients with a mean disease duration of at least 5 years. The two review groups independently extracted the estimates necessary to calculate the NNT. Results: The reviewers consistently selected the same three randomized, controlled trials (RCTs), one for each of the drugs, and extracted equal data for the number of patients completing the 12-month intervention, and the corresponding number of ACR50 responding patients after therapy. Some baseline differences were noted: patients in the etanercept trial had a shorter disease duration and did not receive MTX prior to inclusion; patients in the adalimumab study had lower Health Assessment Questionnaire (HAQ) scores. The calculated NNTs varied slightly depending on the method used. The fully adjusted NNTs (95% confidence intervals) for adalimumab, etanercept, infliximab standard dosage and infliximab double dosage were 4 (3-6), 4 (3-6), 8 (4-66), and 4 (3-11) patients, respectively. Conclusion: This study indicates equal efficacy of the three anti-tumour necrosis factor (TNF) therapies. [ABSTRACT FROM AUTHOR]

Objective: Glucocorticosteroids are used successfully for both systemic and intra‐articular treatment of arthritis. Inhibitors of tumour necrosis factor alpha (TNF‐α) are effective when administered systemically and this study was performed to compare the effect of intra‐articular injection of these two substances.Design: A randomized, parallel‐group, double‐blind study with an independent observer. Thirty‐eight patients with flare of arthritis in a single joint (wrist, elbow, or knee) were given intra‐articular 25 mg etanercept or 40 mg methylprednisolone guided by ultrasound. The primary end‐point was the 4‐week change in pain in the target joint. The study complied with Good Clinical Practice (GCP) and the Consolidated Standards for Reporting of Trials (CONSORT) statement.Results: At 4 weeks no difference in pain outcome between treatment groups was demonstrated by analysis of covariance (ANCOVA). Pain on the Visual Analogue Scale (VAS) for etanercept was baseline mean 40.9 (SD 19.6) mm, follow‐up 32.7 (29.1) mm (p = 0.29), methylprednisolone baseline mean 47.1 (29.6) mm, follow‐up 25.3 (24.7) mm (p<0.001). The investigator's evaluation was for etanercept baseline 30.6 (21.2) mm, follow‐up 17.1 (15.5) mm (p = 0.054) and for methylprednisolone baseline 35.4 (26.4) mm, follow‐up 11.9 (14.6) mm (p = 0.012). Joint swelling was for etanercept baseline 1.78 (0.73), follow‐up 1.25 (0.77) (p = 0.015) and for methylprednisolone baseline 1.74 (0.73), follow‐up 0.71 (0.77) (p<0.001). One serious adverse event was seen in a patient treated with methylprednisolone injection.Conclusion: Although no difference between groups was demonstrated, the within‐group effect of methylprednisolone was more marked than that of etanercept. Injections with 25 mg etanercept were well tolerated. However, the cost of etanercept will presumably limit its use to patients with adverse reactions to steroid. [ABSTRACT FROM AUTHOR]

Background: Etanercept (Enbrel) induces a rapid and sustained decline in disease activity in the majority of patients with refractory rheumatoid arthritis (RA). In these patients neutralization of TNFalpha and lymphotoxin (LT), previously termed TNFbeta is mediated by etanercept itself, as well as by naturally occurring soluble TNF receptors. However, the clinical response to treatment with etanercept may vary. Previously, pharmacokinetic studies have focused on the molar concentrations of etanercept, but very little is known about the kinetics of bioactive etanercept in patients treated with etanercept. The purpose of this study was to evaluate kinetics, including inter- and intraindividual variations of the total TNF binding capacity, in RA patients who were on a standard treatment schedule with etanercept.Methods: Plasma samples were collected daily from 16 RA patients who were in the steady-state phase during treatment with etanercept 25 mg subcutaneous once (n = 2) or twice (n = 14) weekly. The inflammatory activity, including Health Assessment Questionnaire (HAQ) score, numbers of painful and swollen joints, and ESR, was assessed at inclusion; CRP was measured on a daily basis. The samples were incubated with human recombinant LT to a concentration of 1000 pg/mL and the levels of detectable LT were measured by ELISA specific for free LT. The LT binding capacity (LTBC) was expressed in arbitrary units (AU) as the percentage value of bound LT to added LT.Results: The median LTBC values measured during the treatment schedule from Day 1 (before the injection) to Day 4 (before the next injection) were 47 AU. The LTBC values in each individual patient generally remained fairly stable through the treatment schedule, and there were no significant differences in LTBC levels in samples obtained on a daily basis during the treatment schedule. However, a pronounced variation between the patients was noticed with LTBC values ranging from 10-82 AU (coefficient of variation=38%). No significant association was found between LTBC levels and clinical measures of disease activity, including HAQ and numbers of swollen or painful joints. However, among patients with high LTBC levels (> or =65 AU), elevated levels of ESR and CRP were less frequent (0%) compared with patients who had lower LTBC levels, in which the frequencies of elevated ESR and CRP were 53% and 37%, respectively. Soluble TNF receptor 1 (sTNFR1) remained stable between the injections and correlated with the number of swollen joints, but did not correlate with LTBC values.Conclusion: LTBC levels appeared stable in each individual RA patient who was on the standard treatment schedule with weekly injections of etanercept, but the inter-individual variations were considerable. [ABSTRACT FROM AUTHOR]

Objectives: To describe the importance of distinguishing between specific and non-specific therapies offered in low back pain [LBP]. Findings: In acute LBP, manual treatments or specific exercises may shorten the duration of the attack, while long-term effects of these interventions have not been proven. In the individual case, finding and treating a myofascial source of the pain may alter the course of the disease, while these cases apparently vary too much to be studied in regular controlled series. In chronic LBP, specific therapy should be avoided and replaced by active rather than passive therapies. The results of any of the therapies depend on the personality of the therapist and a large placebo effect is encountered. Conclusions: The reassurance of the patient is a very important factor influencing the prognosis. The choice of therapy should take into account the plausibility, safety, cost-effectiveness, and feasibility of the intervention. [ABSTRACT FROM AUTHOR]

There are many indications of defects in motor control being part of the aetiopathogenesis of degenerative joint diseases. Measurement of proprioceptive functions may increase our understanding of these diseases. Furthermore, reproducible tests will enable researchers to demonstrate the results of targeted physiotherapy. The purpose of this study was to determine the test-retest reliability of a method to measure knee joint position sense (JPS). Thirty-nine healthy volunteers (17 women, 18-50 years old) participated. The JPS was measured as the participant's ability to reproduce the same position in the right knee (target vs. estimated angle). The result was expressed as the difference between target and estimated angle. Measurements were repeated three times with three different target angles (prone position: 40°, 70°, 100° flexion; sitting position: 30°, 50°, 70° flexion), and for single leg and both legs. Three test sessions were performed with 1-h and 1-week interval. The outcome measure was the difference between the target and the estimated position (absolute error, AE). The degree of reliability was evaluated by using the intraclass correlation coefficient (ICC). The mean AE summarized for all measurements was 4.16° in sitting position and 5.06° in prone position. The ICCs ranged from 0.31 to 0.82 in sitting position and from 0.17 to 0.75 in prone position. Based upon the fair to good reliability of the applied method for measuring JPS over the knee, we suggest the following procedures for determination of JPS over the knee: (i) the JPS should be calculated as the AE between target and estimate position; (ii) sitting should be preferred to prone; (iii) ipsilateral should be preferred to counter-lateral; (iv) test angle should be in the middle (suggested from 40° to 80° flexion) of the knee joint's range of motion. With these precautions, the test seems to be a reliable measure of JPS in healthy controls. [ABSTRACT FROM AUTHOR]

Objective: To compare bone mass (BMD) in women with fibromyalgia (FM) with healthy females, and to evaluate whether self-reported pain and lack of functional capacity correlate to reduced BMD in FM patients.Methods: Thirty-one FM patients (20 pre- and 11 postmenopausal) and fourty-one healthy women (30 pre- and 10 postmenopausal) were enrolled in the study. BMD of the lumbar spine and the femoral neck was measured by a DEXA (Norland) scanner. Self reported pain was measured on a Visual Analog Scale (VAS). The Activity of Daily Living (ADL) component of the Fibromyalgia Impact Questionnaire (FIQ-ADL) was used as measure for physical capacity.Results: BMD-lumbar spine and BMD-femoral neck did not differ significantly between FM patients and controls, though premenopausal FM patients tended to have lower BMD-femoral neck (p = 0.09). Self reported pain and FIQ-ADL among FM patients correlated with BMD-femoral neck (r(s) = -0.52, p = 0.003); (r(s) = -0.31, p = 0.09).Conclusion: Premenopausal FM patients tended to have lower BMD of hip than controls. Self reported pain correlated negatively to BMD. Thus, the severity of FM might have a negative impact on bone mass. [ABSTRACT FROM AUTHOR]

Objectives: To determine bone mineral density [BMD] of the calcaneus in premenopausal women with fibromyalgia (FMS] as compared to age matched controls.Methods: We measured BMD of the calcaneus in 116 premenopausal women with FMS and made comparisons with 141 age matched controls. Additionally, muscle strength of the thigh was measured in patients with FMS.Results: Patients with FMS and controls were comparable regarding BMD and age, but the controls were slightly taller and had a lower body mass than the patients with FMS. Calcaneus BMD per kg body mass was lower in patients with FMS compared to controls [P < 0.004]. There was no demonstrable correlation between muscle strength of the thigh and BMD of the calcaneus.Conclusions: Patients with FMS maintain normal levels of bone mass in the calcaneus despite a self-reported low level of physical activity. The patients with FMS were obese compared to the controls. This obesity increases the loading on the calcaneus and may preserve bone mass. [ABSTRACT FROM AUTHOR]

Background: The fibromyalgia syndrome [FMS] is a common disorder of unknown etiology. Patients with FMS have diffuse muscle pain accompanied by tenderness at specific points in the muscles and related symptoms from both the nervous and the immune system. An association between FMS and infections with hepatitis virus has been suggested, but findings have been inconclusive.Objective: To determine whether there might be a notable difference in liver enzymes and an association between markers of hepatitis B [HBV] and C virus [HCV] infection and FMS in Denmark.Methods: The study included 39 patients with FMS, 19 with an acute onset of FMS and 20 with a slow onset of symptoms. Fibromyalgia syndrome was diagnosed according to the 1990 American College of Rheumatology criteria.Results: All patients showed negative tests for HBV and HCV and had normal liver enzymes.Conclusion: No correlation was found between infection with hepatitis B or C and the prevalence of FMS in Danish patients. [ABSTRACT FROM AUTHOR]

Objectives: To investigate a possible correlation between the number of tender points [TePs] and the myalgic score versus the Activities of Daily Living [ADL] items and the pain visual analog scale [VAS] of the Fibromyalgia Impact Questionnaire [FIQ].Methods: Consecutive patients with fibromyalgia were included [N = 221; 213 females, eight males, mean age 46 years]. The diagnosis was established using the criteria of the American College of Rheumatology: widespread pain for at least three months and pain on palpation in at least 11 out of 18 specified TeP locations. A 4-point (0-3) scale of pain severity was used. Each patient was evaluated by the number of TePs and by a myalgic score expressed by the summation of the pain severity score multiplied by the respective number of TePs.Before the clinical examination the patients filled in the FIQ. The first 10 subitems of the Flo, measuring physical functioning [FIQ-ADL], were used.Results: The FIQ-ADL was correlated to the following parameters: pain on the VAS [r(s) = 0.46; P < 0.001], the myalgic score [r(s) = 0.30; P < 0.001], and the number of TePs [r(s) = 0.20; P = 0.003].Some correlation between the myalgic score and pain on the VAS was seen [r(s) = 0.15; P = 0.004]. We found no correlation between the number of TePs and pain on the VAS.Conclusion: As an indicator of disability the myalgic score appears to be preferable to the number of TePs. Self-reported pain is correlated to the physical function as expressed by the FIQ-ADL. [ABSTRACT FROM AUTHOR]