Published in 2016

Association of Physical Fitness with Depression in Women with Fibromyalgia

Soriano-Maldonado, A., Estévez-López, F., Segura-Jiménez, V., Aparicio, V. A., Álvarez-Gallardo, I. C., Herrador-Colmenero, M., Ruiz, J. R., Henriksen, M., Amris, K., Delgado-Fernández, M. & al-Ándalus Project 2016 I : Pain medicine (Malden, Mass.). 17, 8, s. 1542-1552

Publikation: Forskning - peer reviewTidsskriftartikel

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 < 0.05). The patients in the highest fitness quintile had 8.4% lower depressive symptoms than the patients in the lowest fitness quintile (P = 0.014). The odds of severe symptoms of depression were between 3.7% and 16.9% lower for each performance unit in the back-scratch, handgrip, arm-curl, and eight-feet up-and-go tests. When all the fitness tests were simultaneously considered, the back-scratch test was the only one independently associated with the total BDI-II score (P = 0.001; R(2) = 0.023).

CONCLUSIONS: . Although higher physical fitness was generally associated with lower symptoms of depression in women with FM, the observed associations were somewhat weak and inconsistent, differing from those previously observed in healthy adults. Further research to determine the clinical relevance of the association between physical fitness and depression in FM is warranted.

Originalsprog Engelsk
Tidsskrift Pain medicine (Malden, Mass.)
Vol/bind 17
Tidsskriftsnummer 8
Sider (fra-til) 1542-1552
ISSN 1526-2375
DOI
Status Udgivet - 2016

Associations Between Swedish Mothers' and 3- and 5-Year-Old Children's Food Intake

Hansson, L. M., Heitmann, B. L., Larsson, C., Tynelius, P., Willmer, M. & Rasmussen, F. sep. 2016 I : Journal of Nutrition Education and Behavior. 48, 8, s. 520-529.e1

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To investigate associations between mothers' and children's food intake.

DESIGN: Cross-sectional study. Background variables collected through self-reports and from the register of the total population. Mothers recorded their own and their children's food intake in a diary during 2 4-day periods.

SETTING: Eight counties in mid Sweden.

PARTICIPANTS: Three- and 5-year-old children and their mothers were randomly selected from the register of the total population. A total of 2,045 families were invited, 355 of whom accepted. Mothers who accepted were older and to a larger extent born in Sweden. The final sample of mother-child pairs with complete food records was 189.

MAIN OUTCOME MEASURES: Mothers' and children's food intake (16 food items).

ANALYSIS: Spearman rank-order correlation with 95% confidence intervals (2-sided). Moderation was investigated using generalized estimation equations with robust variance.

RESULTS: The strongest correlations between mothers' and children's food intake were found for pizza and oily fish (r = .70-.80). The weakest correlations were found for sugared drinks and fruit and berries (r = .24-.26). Children's age moderated the relationship between mothers' and children's intake of savoury snacks, as did place of residence for pizza intake.

CONCLUSIONS AND IMPLICATIONS: There were substantial correlations between children's and mothers' intake of various foods. Modeling of mothers' intake might be more effective in influencing young children's intake of certain foods, whereas other strategies, such as encouraging parents to influence food availability (eg, gatekeeping), might be more useful for some foods.

Originalsprog Engelsk
Tidsskrift Journal of Nutrition Education and Behavior
Vol/bind 48
Tidsskriftsnummer 8
Sider (fra-til) 520-529.e1
ISSN 1499-4046
DOI
Status Udgivet - sep. 2016

Biologic interventions for fatigue in rheumatoid arthritis

Almeida, C., Choy, E. H. S., Hewlett, S., Kirwan, J. R., Cramp, F., Chalder, T., Pollock, J. & Christensen, R. 2016 I : Cochrane Database of Systematic Reviews. 6, s. CD008334

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: Fatigue is a common and potentially distressing symptom for patients with rheumatoid arthritis (RA), with no accepted evidence-based management guidelines. Evidence suggests that biologic interventions improve symptoms and signs in RA as well as reducing joint damage.

OBJECTIVES: To evaluate the effect of biologic interventions on fatigue in rheumatoid arthritis.

SEARCH METHODS: We searched the following electronic databases up to 1 April 2014: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Current Controlled Trials Register, the National Research Register Archive, The UKCRN Portfolio Database, AMED, CINAHL, PsycINFO, Social Science Citation Index, Web of Science, and Dissertation Abstracts International. In addition, we checked the reference lists of articles identified for inclusion for additional studies and contacted key authors.

SELECTION CRITERIA: We included randomised controlled trials if they evaluated a biologic intervention in people with rheumatoid arthritis and had self reported fatigue as an outcome measure.

DATA COLLECTION AND ANALYSIS: Two reviewers selected relevant trials, assessed methodological quality and extracted data. Where appropriate, we pooled data in meta-analyses using a random-effects model.

MAIN RESULTS: We identified 32 studies for inclusion in this current review. Twenty studies evaluated five anti-tumour necrosis factor (anti-TNF) biologic agents (adalimumab, certolizumab, etanercept, golimumab and infliximab), and 12 studies focused on five non-anti-TNF biologic agents (abatacept, canakinumab, rituximab, tocilizumab and an anti-interferon gamma monoclonal antibody). All but two of the studies were double-blind randomised placebo-controlled trials. In some trials, patients could receive concomitant disease-modifying anti-rheumatic drugs (DMARDs). These studies added either biologics or placebo to DMARDs. Investigators did not change the dose of the latter from baseline. In total, these studies included 9946 participants in the intervention groups and 4682 participants in the control groups. Overall, quality of randomised controlled trials was moderate with a low to unclear risk of bias in the reporting of the outcome of fatigue. We downgraded the quality of the studies from high to moderate because of potential reporting bias (studies included post hoc analyses favouring reporting of positive result and did not always include all randomised individuals). Some studies recruited only participants with early disease. The studies used five different instruments to assess fatigue in these studies: the Functional Assessment of Chronic Illness Therapy Fatigue Domain (FACIT-F), Short Form-36 Vitality Domain (SF-36 VT), Visual Analogue Scale (VAS) (0 to 100 or 0 to 10) and the Numerical Rating Scale (NRS). We calculated standard mean differences for pooled data in meta-analyses. Overall treatment by biologic agents led to statistically significant reduction in fatigue with a standardised mean difference of -0.43 (95% confidence interval (CI) -0.38 to -0.49). This equates to a difference of 6.45 units (95% CI 5.7 to 7.35) of FACIT-F score (range 0 to 52). Both types of biologic agents achieved a similar level of improvement: for anti-TNF agents, this stood at -0.42 (95% CI -0.35 to -0.49), equivalent to 6.3 units (95% CI 5.3 to 7.4) on the FACIT-F score; and for non-anti-TNF agents, it was -0.46 (95% CI -0.39 to -0.53), equivalent to 6.9 units (95% CI 5.85 to 7.95) on the FACIT-F score. In most studies, the double-blind period was 24 weeks or less. No study assessed long-term changes in fatigue.

AUTHORS' CONCLUSIONS: Treatment with biologic interventions in patients with active RA can lead to a small to moderate improvement in fatigue. The magnitude of improvement is similar for anti-TNF and non-anti-TNF biologics. However, it is unclear whether the improvement results from a direct action of the biologics on fatigue or indirectly through reduction in inflammation, disease activity or some other mechanism.

Originalsprog Engelsk
Tidsskrift Cochrane Database of Systematic Reviews
Tidsskriftsnummer 6
Sider (fra-til) CD008334
ISSN 1469-493X
DOI
Status Udgivet - 2016

Biological agents in polyarticular juvenile idiopathic arthritis: A meta-analysis of randomized withdrawal trials

Amarilyo, G., Tarp, S., Foeldvari, I., Cohen, N., Pope, T. D., Woo, J. M. P., Christensen, R. & Furst, D. E. dec. 2016 I : Seminars in Arthritis and Rheumatism. 46, 3, s. 312-318 7 s.

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND AND OBJECTIVE: Although various biological agents are in use for polyarticular juvenile idiopathic arthritis (pJIA), head-to-head trials comparing the efficacy and safety among them are lacking. We aimed to compare the efficacy and safety of biological agents in pJIA using all currently available randomized withdrawal trials (wRCTs).

METHODS: A systematic search of MEDLINE, EMBASE, CENTRAL, and clinicaltrials.gov was performed. Eligible wRCTs: patients with pJIA where a biological agent was compared with another biological agent or placebo. Efficacy was evaluated using disease flare as a measure. Adverse events (AEs) and serious AEs were evaluated. Network meta-analysis compared biological agents based on a (empirical Bayes) mixed-effects logistic regression model that combines statistical inference from both direct and indirect comparisons of the treatment effects between biological agents.

RESULTS: Of 496 references identified, five wRCTs were included-abatacept, adalimumab, anakinra, etanercept, and tocilizumab, one trial each, all vs. placebo. There were no differences in efficacy among biological agents and most showed statistically significant efficacy compared with placebo (nearly all exceptions were in agreement with the original study data). Serious AEs occurred very infrequently (0-8%) and an analysis was not possible. There were no differences for AEs when compared among biological agents or to placebo.

CONCLUSION: There were no statistical differences among biological agents for efficacy or safety. Overall, biological agents were effective and safe when compared to placebo. Based on these data, other considerations such as price and availability may need to be used to decide among biological agents when treating pJIA patients.

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 46
Tidsskriftsnummer 3
Sider (fra-til) 312-318
Antal sider 7
ISSN 0049-0172
DOI
Status Udgivet - dec. 2016

Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease-modifying anti-rheumatic drugs: a systematic review and network meta-analysis

Singh, J. A., Hossain, A., Tanjong Ghogomu, E., Kotb, A., Christensen, R., Mudano, A. S., Maxwell, L. J., Shah, N. P., Tugwell, P. & Wells, G. A. 2016 I : Cochrane Database of Systematic Reviews. 5, s. CD012183

Publikation: Forskning - peer reviewTidsskriftartikel

BACKGROUND: This is an update of the 2009 Cochrane overview and network meta-analysis (NMA) of biologics for rheumatoid arthritis (RA).

OBJECTIVES: To assess the benefits and harms of nine biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib, versus comparator (MTX, DMARD, placebo (PL), or a combination) in adults with rheumatoid arthritis who have failed to respond to methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs), i.e., MTX/DMARD incomplete responders (MTX/DMARD-IR).

METHODS: We searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (via The Cochrane Library Issue 6, June 2015), MEDLINE (via OVID 1946 to June 2015), and EMBASE (via OVID 1947 to June 2015). Data extraction, risk of bias and GRADE assessments were done in duplicate. We calculated both direct estimates using standard meta-analysis and used Bayesian mixed treatment comparisons approach for NMA estimates to calculate odds ratios (OR) and 95% credible intervals (CrI). We converted OR to risk ratios (RR) which are reported in the abstract for the ease of interpretation.

MAIN RESULTS: This update included 73 new RCTs for a total of 90 RCTs; 79 RCTs with 32,874 participants provided usable data. Few trials were at high risk of bias for blinding of assessors/participants (13% to 21%), selective reporting (4%) or major baseline imbalance (8%); a large number had unclear risk of bias for random sequence generation (68%) or allocation concealment (74%).Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a statistically significant and clinically meaningful improvement in ACR50 versus comparator (RR 2.71 (95% confidence interval (CI) 2.36 to 3.10); absolute benefit 24% more patients (95% CI 19% to 29%), number needed to treat for an additional beneficial outcome (NNTB) = 5 (4 to 6). NMA estimates for ACR50 in tumor necrosis factor (TNF) biologic+MTX/DMARD (RR 3.23 (95% credible interval (Crl) 2.75 to 3.79), non-TNF biologic+MTX/DMARD (RR 2.99; 95% Crl 2.36 to 3.74), and anakinra + MTX/DMARD (RR 2.37 (95% Crl 1.00 to 4.70) were similar to the direct estimates.Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a clinically and statistically important improvement in function measured by the Health Assessment Questionnaire (0 to 3 scale, higher = worse function) with a mean difference (MD) based on direct evidence of -0.25 (95% CI -0.28 to -0.22); absolute benefit of -8.3% (95% CI -9.3% to -7.3%), NNTB = 3 (95% CI 2 to 4). NMA estimates for TNF biologic+MTX/DMARD (absolute benefit, -10.3% (95% Crl -14% to -6.7%) and non-TNF biologic+MTX/DMARD (absolute benefit, -7.3% (95% Crl -13.6% to -0.67%) were similar to respective direct estimates.Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with clinically and statistically significantly greater proportion of participants achieving remission in RA (defined by disease activity score DAS < 1.6 or DAS28 < 2.6) versus comparator (RR 2.81 (95% CI, 2.23 to 3.53); absolute benefit 18% more patients (95% CI 12% to 25%), NNTB = 6 (4 to 9)). NMA estimates for TNF biologic+MTX/DMARD (absolute improvement 17% (95% Crl 11% to 23%)) and non-TNF biologic+MTX/DMARD (absolute improvement 19% (95% Crl 12% to 28%) were similar to respective direct estimates.Based on direct evidence of moderate quality (downgraded for inconsistency), radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologics + MTX/DMARDs versus comparator, MD -2.61 (95% CI -4.08 to -1.14). The absolute reduction was small, -0.58% (95% CI -0.91% to -0.25%) and we are unsure of the clinical relevance of this reduction. NMA estimates of TNF biologic+MTX/DMARD (absolute reduction -0.67% (95% Crl -1.4% to -0.12%) and non-TNF biologic+MTX/DMARD (absolute reduction, -0.68% (95% Crl -2.36% to 0.92%)) were similar to respective direct estimates.Based on direct evidence of moderate quality (downgraded for imprecision), results for withdrawals due to adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase in withdrawals, RR 1.11 (95% CI 0.96 to 1.30). The NMA estimates of TNF biologic+MTX/DMARD (RR 1.24 (95% Crl 0.99 to 1.57)) and non-TNF biologic+MTX/DMARD (RR 1.20 (95% Crl 0.87 to 1.67)) were similarly inconclusive and downgraded to low for both imprecision and indirectness.Based on direct evidence of high quality, biologic+MTX/DMARD was associated with clinically significantly increased risk (statistically borderline significant) of serious adverse events on biologic+MTX/DMARD (Peto OR [can be interpreted as RR due to low event rate] 1.12 (95% CI 0.99 to 1.27); absolute risk 1% (0% to 2%), As well, the NMA estimate for TNF biologic+MTX/DMARD (Peto OR 1.20 (95% Crl 1.01 to 1.43)) showed moderate quality evidence of an increase in the risk of serious adverse events. The other two NMA estimates were downgraded to low quality due to imprecision and indirectness and had wide confidence intervals resulting in uncertainty around the estimates: non-TNF biologics + MTX/DMARD: 1.07 (95% Crl 0.89 to 1.29) and anakinra: RR 1.06 (95% Crl 0.65 to 1.75).Based on direct evidence of low quality (downgraded for serious imprecision), results were inconclusive for cancer (Peto OR 1.07 (95% CI 0.68 to 1.68) for all biologic+MTX/DMARD combinations. The NMA estimates of TNF biologic+MTX/DMARD (Peto OR 1.21 (95% Crl 0.63 to 2.38) and non-TNF biologic+MTX/DMARD (Peto OR 0.99 (95% Crl 0.58 to 1.78)) were similarly inconclusive and downgraded to low quality for both imprecision and indirectness.Main results text shows the results for tofacitinib and differences between medications.

AUTHORS' CONCLUSIONS: Based primarily on RCTs of 6 months' to 12 months' duration, there is moderate quality evidence that the use of biologic+MTX/DMARD in people with rheumatoid arthritis who have failed to respond to MTX or other DMARDs results in clinically important improvement in function and higher ACR50 and remission rates, and increased risk of serious adverse events than the comparator (MTX/DMARD/PL; high quality evidence). Radiographic progression is slowed but its clinical relevance is uncertain. Results were inconclusive for whether biologics + MTX/DMARDs are associated with an increased risk of cancer or withdrawals due to adverse events.

Originalsprog Engelsk
Tidsskrift Cochrane Database of Systematic Reviews
Tidsskriftsnummer 5
Sider (fra-til) CD012183
ISSN 1469-493X
DOI
Status Udgivet - 2016

Calcium, vitamin D, casein and whey protein intakes and periodontitis among Danish adults

Adegboye, A. R., Boucher, B. J., Kongstad, J., Fiehn, N-E., Christensen, L. B. & Heitmann, B. L. feb. 2016 I : Public Health Nutrition. 19, 3, s. 503-10 8 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To investigate whether intakes of Ca, vitamin D, casein and whey are associated with periodontitis and to investigate the possibility of interactions between them.

DESIGN: Cross-sectional study. An Internet-based, 267-item FFQ was used to assess dietary intake. Intakes of casein (32·0 g/d), whey proteins (9·6 g/d) and vitamin D (5·8 μg/d) were classified as within v. above the 50th percentile. Ca intake was classified as within v. below age-specific recommendations. Severe periodontitis was defined as having ≥2 inter-proximal sites with clinical attachment loss ≥6 mm (not on the same tooth) and ≥1 inter-proximal site with pocket depth ≥5 mm. Since vitamin D influences Ca absorption, models were stratified by lower and higher (<5·8 v. ≥5·8 µg/d) vitamin D intake.

SETTING: Danish Health Examination Survey (DANHES) 2007-2008.

SUBJECTS: Adult participants (n 3287) in the oral health study of DANHES 2007-2008.

RESULTS: Intakes of Ca within recommendations (OR=0·76; 95 % CI 0·58, 0·99), whey ≥9·6 g/d (OR=0·75; 95 % CI 0·58, 0·97) and casein ≥32 g/d (OR=0·75 95 % CI 0·58, 0·97) were associated with lower likelihood of severe periodontitis after adjustment for age, gender, education, smoking, sucrose intake, alcohol consumption, number of teeth, daily brushing, regular visits to the dentist and chronic illness, irrespective of vitamin D intake levels. Intake of vitamin D alone was not associated severe with periodontitis.

CONCLUSIONS: Intakes of Ca, casein and whey protein were inversely associated with periodontitis. Consumption of foods rich in Ca, casein and whey (e.g. dairy foods) should be promoted, as they may contribute to the prevention of periodontitis. Further longitudinal studies are required to confirm these associations.

Originalsprog Engelsk
Tidsskrift Public Health Nutrition
Vol/bind 19
Tidsskriftsnummer 3
Sider (fra-til) 503-10
Antal sider 8
ISSN 1368-9800
DOI
Status Udgivet - feb. 2016

BACKGROUND: Positional MRI (pMRI) allows for three-dimensional visual assessment of navicular position. In this exploratory pilot study pMRI was validated against a stretch sensor device, which measures movement of the medial plantar arch. We hypothesized that a combined pMRI measure incorporating both vertical and medial displacement of the navicular bone induced by loading would be correlated with corresponding stretch sensor measurements.

METHODS: 10 voluntary participants were included in the study. Both pMRI and subsequent stretch sensor measurements were performed in a) supine, b) standing and c) standing position with addition of 10 % body weight during static loading of the foot. Stretch sensor measurements were also performed during barefoot walking.

RESULTS: The total change in navicular position measured by pMRI was 10.3 mm (CI: 7.0 to 13.5 mm). No further displacement occurred when adding 10 % bodyweight (mean difference: 0.7 mm (CI: -0.7 to 2.0 mm), P = 0.29). The total navicular displacement correlated with stretch sensor measurement under static loading conditions (Spearman's rho = 0.66, P = 0.04) but not with measurements during walking (Spearman's rho = 0.58, P = 0.08).

CONCLUSIONS: Total navicular bone displacements determined by pMRI showed concurrent validity with stretch sensor measurements but only so under static loading conditions. Although assessment of total navicular displacement by combining concomitant vertical and medial navicular bone movements would appear advantageous compared to monoplanar measurement the combined measure did not seem to predict dynamic changes of the medial foot arch during walking, which are among several possible factors depending on different walking patterns.

Originalsprog Engelsk
Tidsskrift Journal of Foot & Ankle Surgery
Vol/bind 9
Sider (fra-til) 35
ISSN 1067-2516
DOI
Status Udgivet - 2016

OBJECTIVE: Knee osteoarthritis (KOA) is a multifactorial joint disease affecting many people worldwide. Recommended treatments for KOA include exercise and steroid injections, or a combination of these. The objective of this exploratory outcome analysis of a randomized trial was to assess changes in inflammation markers assessed by ultrasound imaging (US) in KOA secondary to intra-articular corticosteroid injection given prior to exercise therapy.

DESIGN: This study is a sub-study to a larger clinical trial which compared the clinical effects of steroid injection in KOA to placebo injection, both given prior to exercise therapy. The US outcomes were changes from baseline in US-assessed synovial size, Doppler activity presence in the synovial membrane, and numbers of US-detected Baker's cysts. US was performed at baseline, week 14 (exercise stop), and week 26 (follow-up).

RESULTS: Fifty participants received steroid injection, and 50 received placebo injection. All participants received 12 weeks of exercise. Forty-five and 44, respectively, completed the study. At week 14, the group difference in the change in synovium thickness was 2.2 mm (95%, confidence interval (CI) -0.5 to 4.8), P = 0.11. There were no group differences in the changes in distribution of patients with presence of synovial Doppler activity (P = 0.98) or Baker's cysts (P = 0.35). There were no statistically significant differences between groups at week 26 in any outcome.

CONCLUSION: Intra-articular steroid injection of KOA-patients prior to a 3 months exercise programme did not reduce synovial hypertrophy, synovial Doppler activity, or Baker's cyst presence more than a placebo saline injection according to US-assessments.

TRIAL REGISTRATION: EudraCT: 2012-002607-18.

Originalsprog Engelsk
Tidsskrift Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Vol/bind 24
Tidsskriftsnummer 5
Sider (fra-til) 814-21
Antal sider 8
ISSN 1063-4584
DOI
Status Udgivet - maj 2016

Chronic Neck Pain Assessment using Multi-Frequency Bioimpedance

Fener, D. K., Bartels, E. M., Elbrønd, V. S. & Harrison, A. P. 2016 I : Journal og Physiotherapy & Physical Rehabilitation. 1, 2, s. 1-6 6 s.

Publikation: Forskning - peer reviewTidsskriftartikel

Scope: Chronic neck pain (CNP) is a disabling condition where the cause is often unknown, making treatment difficult. Muscle involvement is suspected in most cases, and assessment of muscle condition and changes following treatment may be possible with multi-frequency bioimpedance (mfBIA). Our aim was to test mfBIA as an assessment method of possible involvement of the neck, back and other related muscles in two CNP patients, prior to and following physiotherapy treatment with AtlasBalans.
Methods: mfBIA measurements were carried out pre-treatment on m. sternocleidomastoideus, m. trapezius, upper back, lower back, m. vastus lateralis, and m. gastrocnemius. Centre frequency (fc), extracellular Resistance
(Re) and intracellular Resistance (Ri), Impedance (Z), Resistance (R) and Reactance (Xc) were measured, and Phase Angle (PA) and Membrane Capacitance (Mc) were calculated, using ImpediMed Inc software. AtlasBalans treatment was carried out on m. sternocleidomastoideus and m. trapezius with following mfBIA measurement of these. Relationship between Z, R, fc, Ri and Mc was studied pre and post-treatment.
Results: The Z and R data suggested no great degree of inflammation or overuse of the measured muscles. The fc data indicate muscle involvement with elevated resting tension and imbalance between the left and right sides. Ri and Mc confirm the interpretation of imbalance, indicating an elevated metabolic activity in some muscles.
Conclusion: mfBIA seems a promising method to follow muscle involvement in chronic neck pain patients. AtlasBalans treatment did not show any clear indication as being an efficient form of treatment to relieve muscle
tension in CNP patients.
Originalsprog Engelsk
Tidsskrift Journal og Physiotherapy & Physical Rehabilitation
Vol/bind 1
Tidsskriftsnummer 2
Sider (fra-til) 1-6
Antal sider 6
Status Udgivet - 2016

Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA)

Hørslev-Petersen, K., Hetland, M. L., Ørnbjerg, L. M., Junker, P., Pødenphanth, J., Ellingsen, T., Ahlquist, P., Lindegaard, H., Linauskas, A., Schlemmer, A., Dam, M. Y., Hansen, I., Lottenburger, T., Ammitzbøll, C. G., Jørgensen, A., Krintel, S. B., Raun, J., Johansen, J. S., Østergaard, M., Stengaard-Pedersen, K., OPERA Study-Group, Slot, O., Skjødt, H., Manilo, N. & Bliddal, H. 2016 I : Annals of the Rheumatic Diseases. 75, 9, s. 1645-53 9 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: To study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647).

METHODS: Disease-modifying antirheumatic drug (DMARD)-naive patients with eRA started methotrexate (20 mg/week) and intra-articular triamcinolone (20 mg/ml) for 2 years. In addition, they were randomised to receive placebo adalimumab (DMARD group, n=91) or adalimumab (40 mg/every other week) (DMARD+adalimumab group, n=89) during the first year. Sulfasalazine and hydroxychloroquine were added if disease activity persisted after 3 months. During year 2, synthetic DMARDs continued. Adalimumab was (re)initiated if active disease reoccurred. Clinical response, remission, disability, quality of life and radiographic changes were assessed.

RESULTS: One year after adalimumab withdrawal, treatment profiles and clinical responses did not differ between groups. In the DMARD/DMARD+adalimumab groups, the median 2-year methotrexate dose was 20/20 mg/week (p=0.45), triple DMARD therapy had been initiated in 33/27 patients (p=0.49), adalimumab was (re)initiated in 12/12 patients and cumulative triamcinolone dose was 160/120 mg (p=0.15). The treatment target (disease activity score, 4 variables, C-reactive protein (DAS28CRP) ≤3.2 or DAS28>3.2 without swollen joints) was achieved at all visits in ≥85% of patients in year 2; remission rates were DAS28CRP<2.6:69%/66%; Clinical Disease Activity Index ≤2.8:55%/57%; Simplified Disease Activity Index <3.3:54%/49%; American College of Rheumatology/European League against Rheumatism (28 joints):44%/45% (p=0.66-1.00). Radiographic progression (Δtotal Sharp score/year) was similar 1.31/0.53 (p=0.12). Erosive progression (Δerosion score (ES)/year) was year 1:0.57/0.06 (p=0.02); year 2:0.38/0.05 (p=0.005). Proportion of patients without erosive progression (ΔES≤0) was year 1: 59%/76% (p=0.03); year 2:64%/79% (p=0.04).

CONCLUSIONS: An aggressive triamcinolone and synthetic DMARD treat-to-target strategy in eRA provided excellent 2-year clinical and radiographic disease control independent of adalimumab induction therapy. ES progression was slightly less during and following adalimumab induction therapy.

TRIAL REGISTRATION NUMBER: NCT00660647.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 75
Tidsskriftsnummer 9
Sider (fra-til) 1645-53
Antal sider 9
ISSN 0003-4967
DOI
Status Udgivet - 2016

Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials

Altman, R. D., Devji, T., Bhandari, M., Fierlinger, A., Niazi, F. & Christensen, R. okt. 2016 I : Seminars in Arthritis and Rheumatism. 46, 2, s. 151-9 9 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVES: Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm. Using a systematic review and meta-analysis, our objective was to assess the clinical benefit associated with use of IA saline in trials of IA therapies in the treatment of patients with painful knee OA.

METHODS: MEDLINE and Embase databases were searched for articles published up to and including August 14th, 2014. Two reviewers assessed the eligibility of potential reports and the risk of bias of included trials. We analyzed short (≤3 months) and long-term (6-12 months) pain reduction of the saline arm of included trials using standardized mean differences (SMDs; estimated assuming a null effect in a comparator group) that were combined and weighted using a random effects model. Treatment-related adverse events (AEs) were tabulated and presented using descriptive statistics.

RESULTS: From 40 randomized controlled trials (RCTs) eligible for inclusion only 38 provided sufficient data to be included in the meta-analysis. Based on data with moderate inconsistency IA saline was found to significantly improve short-term knee pain in 32 studies involving 1705 patients (SMD = -0.68; 95% CI: -0.78 to -0.57; P < 0.001; I(2) = 50%). Long-term knee pain was significantly decreased following IA injection with saline in 19 studies involving 1445 patients (SMD = -0.61; 95% CI: -0.76 to -0.45; P < 0.001) with a substantial degree of inconsistency (I(2) = 74%). Overall, 29 of the included trials reported on adverse events, none of which found any serious treatment-related AEs following IA injection with saline.

CONCLUSIONS: Pain relief observed with IA saline should prompt health care providers to consider the additional effectiveness of current IA treatments that use saline comparators in clinical studies, and challenges of identifying IA saline injection as a "placebo."

Originalsprog Engelsk
Tidsskrift Seminars in Arthritis and Rheumatism
Vol/bind 46
Tidsskriftsnummer 2
Sider (fra-til) 151-9
Antal sider 9
ISSN 0049-0172
DOI
Status Udgivet - okt. 2016

AIM: Evidence of comparative effectiveness of different treatment approaches is important for clinical decision-making, yet absent for most recommended treatments of knee osteoarthritis pain. The objective of this study was to estimate the comparative effectiveness of exercise versus orally administered analgesics for pain in patients with knee osteoarthritis.

METHODS: The Cochrane Database of systematic reviews was searched for meta-analyses of randomized controlled studies comparing exercise or analgesics with a control group (placebo or usual care) and with pain as an outcome. Individual study estimates were identified and effect sizes were calculated from group differences. We combined study-level effects on pain with a random effects meta-analysis and compared effect sizes between exercise trials and trials with analgesic interventions.

RESULTS: We included six Cochrane reviews (four pharmacology, two exercise). From these, 54 trials were eligible (20 pharmacology, 34 exercise), with 9806 participants (5627 pharmacology, 4179 exercise). The pooled effect size of pharmacological pain interventions was 0.41 (95% CI: 0.23-0.59) and for exercise 0.46 standardized mean difference (95% CI: 0.34-0.59). There was no statistically significant difference between the two types of intervention (difference: 0.06 standardized mean difference [95% CI: -0.28-0.16; p = 0.61]).

CONCLUSION: This meta-epidemiological study provides indirect evidence that for knee osteoarthritis pain, the effects from exercise and from oral analgesics are comparable. These results may support shared decision-making where a patient for some reason is unable to exercise or who consider exercise as unviable and analgesics as a more feasible choice. PROSPERO registration: CRD42013006924.

Originalsprog Engelsk
Tidsskrift Journal of Comparative Neurology
Vol/bind 5
Tidsskriftsnummer 4
Sider (fra-til) 417-31
Antal sider 15
ISSN 0021-9967
DOI
Status Udgivet - jul. 2016

Conditioning pain stimulation does not affect itch induced by intra-epidermal histamine pricks but aggravates neurogenic inflammation in healthy volunteers

Andersen, H. H., Imai, Y., Petersen, K. K., Koenig, J., Elberling, J. & Arendt-Nielsen, L. mar. 2016 I : Somatosensory & motor research. 33, 1, s. 49-60 12 s.

Publikation: Forskning - peer reviewTidsskriftartikel

This study investigated whether itch induced by intra-epidermal histamine is subjected to modulation by a standardized conditioned pain modulation (CPM) paradigm in 24 healthy volunteers. CPM was induced by computer-controlled cuff pressure algometry and histamine was introduced to the volar forearm by skin prick test punctures. Moreover, neurogenic inflammation and wheal reactions induced by histamine and autonomic nervous system responses (heart rate variability and skin conductance) were monitored. CPM did not modulate the intensity of histamine-induced itch suggesting that pruriceptive signaling is not inhibited by pain-recruited endogenous modulation, however, CPM was found to aggravate histamine-induced neurogenic inflammation, likely facilitated by efferent sympathetic fibers.

Originalsprog Engelsk
Tidsskrift Somatosensory & motor research
Vol/bind 33
Tidsskriftsnummer 1
Sider (fra-til) 49-60
Antal sider 12
ISSN 0899-0220
DOI
Status Udgivet - mar. 2016

OBJECTIVES: Rheumatoid arthritis (RA) patients suffer from disabling fatigue but the causes of this condition are unknown. Our aim was to assess which of the variables disease activity, disease duration, and pain is associated with fatigue.

METHOD: We conducted a systematic literature search in MEDLINE and EMBASE, followed by selection of studies according to set criteria, data extraction, and statistical analyses of the relationships in RA between fatigue and the following covariates: disease duration, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), the 28-joint Disease Activity Score (DAS28), swollen to tender joint count ratio (STR), and pain. Linear regression analyses of fatigue regressed on each of the six covariates, and a multiple regression analysis where fatigue was regressed on the six covariates through a forward selection procedure was carried out with construction of correlation measures between fatigue and the covariates.

RESULTS: A total of 121 studies were included in the analyses, including > 100 000 RA patients. A high level of fatigue was seen even in well-treated patients, demonstrating fatigue as a major problem in RA. Fatigue was found to be positively correlated with pain, CRP, DAS28, and ESR but not with the STR or disease duration, with pain as the overall domineering factor.

CONCLUSIONS: Fatigue has a substantial influence on the lives of RA patients, independent of disease duration. Pain is the domineering factor in the experience and degree of fatigue. Disease activity is positively correlated to fatigue but does not contribute substantially when pain is considered. Optimal pain relief is therefore an important part of the treatment to improve fatigue in RA.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Rheumatology
Vol/bind 45
Tidsskriftsnummer 4
Sider (fra-til) 255-61
Antal sider 7
ISSN 0300-9742
DOI
Status Udgivet - jul. 2016

Costs in Relation to Disability, Disease Activity, and Health-related Quality of Life in Rheumatoid Arthritis: Observational Data from Southern Sweden

Wallman, J. K., Eriksson, J. K., Nilsson, J-Å., Olofsson, T., Kristensen, L-E., Neovius, M. & Geborek, P. jul. 2016 I : Journal of Rheumatology. 43, 7, s. 1292-9 8 s.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: To compare how costs relate to disability, disease activity, and health-related quality of life (HRQOL) in rheumatoid arthritis (RA).

METHODS: Antitumor necrosis factor (anti-TNF)-treated patients with RA in southern Sweden (n = 2341) were monitored 2005-2010. Health Assessment Questionnaire (HAQ), 28-joint Disease Activity Score (DAS28), and EQ-5D scores were linked to register-derived costs of antirheumatic drugs (excluding anti-TNF agents), patient care, and work loss from 30 days before to 30 days after each visit (n = 13,289). Associations of HAQ/DAS28/EQ-5D to healthcare (patient care and drugs) and work loss costs (patients < 65 yrs) were studied in separate regression models, comparing standardized β coefficients by nonparametric bootstrapping to assess which measure best reflects costs. Analyses were conducted based on both individual means (linear regression, comparing between-patient associations) and by generalized estimating equations (GEE), using all observations to also account for within-patient associations of HAQ/DAS28/EQ-5D to costs.

RESULTS: Regardless of the methodology (linear or GEE regression), HAQ was most closely related to both cost types, while work loss costs were also more closely associated with EQ-5D than DAS28. The results of the linear models for healthcare costs were standardized β = 0.21 (95% CI 0.15-0.27), 0.16 (0.11-0.21), and -0.15 (-0.21 to -0.10) for HAQ/DAS28/EQ-5D, respectively (p < 0.05 for HAQ vs DAS28/EQ-5D). For work loss costs, the results were standardized β = 0.43 (95% CI 0.39-0.48), 0.27 (0.23-0.32), and -0.34 (-0.38 to -0.29) for HAQ/DAS28/EQ-5D, respectively (p < 0.05 for HAQ vs DAS28/EQ-5D and for EQ-5D vs DAS28).

CONCLUSION: Overall, HAQ disability is a better marker of RA costs than DAS28 or EQ-5D HRQOL.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
Vol/bind 43
Tidsskriftsnummer 7
Sider (fra-til) 1292-9
Antal sider 8
ISSN 0315-162X
DOI
Status Udgivet - jul. 2016

Danish VISA-A questionnaire with validation and reliability testing for Danish-speaking Achilles tendinopathy patients

Iversen, J. V., Bartels, E. M., Jørgensen, J. E., Nielsen, T. G., Ginnerup, C., Lind, M. C. & Langberg, H. dec. 2016 I : Scandinavian journal of medicine & science in sports. 26, 12, s. 1423-1427 5 s.

Publikation: Forskning - peer reviewTidsskriftartikel

The VISA-A questionnaire has proven to be a valid and reliable tool for assessing severity of Achilles tendinopathy (AT). The aim was to translate and cross-culturally adapt the VISA-A questionnaire for a Danish-speaking AT population, and subsequently perform validity and reliability tests. Translation and following cross-cultural adaptation was performed as translation, synthesis, reverse translation, expert review, and pretesting. The final Danish version (VISA-A-DK) was tested for reliability on healthy controls (n = 75) and patients (n = 36). Tests for internal consistency, validity, and structure were performed on 71 patients. VISA-A-DK showed good reliability for patients (r = 0.80 ICC = 0.79) and healthy individuals (r = 0.98 ICC = 0.97). Internal consistency was 0.73 (Cronbach's alpha). The mean VISA-A-DK score in AT patients was 51 [47-55]. This was significantly lower than healthy controls with a score of 93 (90-95). Criterion validity was considered good when comparing the scores of the Danish version with the original version in both healthy individuals and patients. VISA-A-DK is a valid and reliable instrument and has shown compatible to the original version in assessment of AT patients. VISA-A-DK is a useful tool in the assessment of AT, both in research and in a clinical setting.

Originalsprog Engelsk
Tidsskrift Scandinavian journal of medicine & science in sports
Vol/bind 26
Tidsskriftsnummer 12
Sider (fra-til) 1423-1427
Antal sider 5
ISSN 0905-7188
DOI
Status Udgivet - dec. 2016

Defining conditions where long-term glucocorticoid treatment has an acceptably low level of harm to facilitate implementation of existing recommendations: viewpoints from an EULAR task force

Strehl, C., Bijlsma, J. W. J., de Wit, M., Boers, M., Caeyers, N., Cutolo, M., Dasgupta, B., Dixon, W. G., Geenen, R., Huizinga, T. W. J., Kent, A., de Thurah, A. L., Listing, J., Ray, D. W., Scherer, H. U., Seror, R., Spies, C. M., Tarp, S., Wiek, D. & Buttgereit, F. jun. 2016 I : Annals of the Rheumatic Diseases. 75, 6, s. 952-7 6 s.

Publikation: Forskning - peer reviewTidsskriftartikel

There is convincing evidence for the known and unambiguously accepted beneficial effects of glucocorticoids at low dosages. However, the implementation of existing recommendations and guidelines on the management of glucocorticoid therapy in rheumatic diseases is lagging behind. As a first step to improve implementation, we aimed at defining conditions under which long-term glucocorticoid therapy may have an acceptably low level of harm. A multidisciplinary European League Against Rheumatism task force group of experts including patients with rheumatic diseases was assembled. After a systematic literature search, breakout groups critically reviewed the evidence on the four most worrisome adverse effects of glucocorticoid therapy (osteoporosis, hyperglycaemia/diabetes mellitus, cardiovascular diseases and infections) and presented their results to the other group members following a structured questionnaire for final discussion and consensus finding. Robust evidence on the risk of harm of long-term glucocorticoid therapy was often lacking since relevant study results were often either missing, contradictory or carried a high risk of bias. The group agreed that the risk of harm is low for the majority of patients at long-term dosages of ≤5 mg prednisone equivalent per day, whereas at dosages of >10 mg/day the risk of harm is elevated. At dosages between >5 and ≤10 mg/day, patient-specific characteristics (protective and risk factors) determine the risk of harm. The level of harm of glucocorticoids depends on both dose and patient-specific parameters. General and glucocorticoid-associated risk factors and protective factors such as a healthy lifestyle should be taken into account when evaluating the actual and future risk.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 75
Tidsskriftsnummer 6
Sider (fra-til) 952-7
Antal sider 6
ISSN 0003-4967
DOI
Status Udgivet - jun. 2016

Defining The Optimal Biological Monotherapy in Rheumatoid Arthritis: A Systematic Review and Network Meta-Analysis of Randomised Trials

Tarp, S., Furst, D. E., Døssing, A., Østergaard, M., Lorenzen, T., Hansen, M., Singh, J., Choy, E., Boers, M., Suarez-Almazor, M., Kristensen, L., Bliddal, H. & Christensen, R. 2016 I : Annals of the Rheumatic Diseases. 75, Suppl. 2, s. 423-4 2 s., THU0635

Publikation: Forskning - peer reviewKonferenceabstrakt i tidsskrift

Originalsprog Engelsk
Artikelnummer THU0635
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 75
Tidsskriftsnummer Suppl. 2
Sider (fra-til) 423-4
Antal sider 2
ISSN 0003-4967
Status Udgivet - 2016

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group

Klokker, L., Tugwell, P., Furst, D. E., Devoe, D., Williamson, P., Terwee, C. B., Suarez-Almazor, M. E., Strand, V., Woodworth, T., Leong, A. L., Goel, N., Boers, M., Brooks, P. M., Simon, L. S. & Christensen, R. 15 okt. 2016 I : Journal of Rheumatology.

Publikation: Forskning - peer reviewTidsskriftartikel

OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions.

METHODS: The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved.

RESULTS: Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions.

CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Originalsprog Engelsk
Tidsskrift Journal of Rheumatology
ISSN 0315-162X
DOI
Status E-pub ahead of print - 15 okt. 2016
Originalsprog Engelsk
Udgivelses sted Odense
Vol/bind 1
Udgave 1
Antal sider 100
Status Udgivet - 29 apr. 2016

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