Published in 2014

Osteoarthritis, obesity and weight loss: evidence, hypotheses and horizons - a scoping review

Bliddal, H., Leeds, A. R. & Christensen, R., jul. 2014, I: Obesity reviews : an official journal of the International Association for the Study of Obesity. 15, 7, s. 578-86 9 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Obesity is widely acknowledged as a risk factor for both the incidence and progression of osteoarthritis, and has a negative influence on outcomes. Loss of at least 10% of body weight, coupled with exercise, is recognized as a cornerstone in the management of obese patients with osteoarthritis, and can lead to significant improvement in symptoms, pain relief, physical function and health-related quality of life. However, questions still remain surrounding optimal management. Given the significant health, social and economic burden of osteoarthritis, especially in obese patients, it is imperative to advance our knowledge of osteoarthritis and obesity, and apply this to improving care and outcomes. This paper overviews what is already known about osteoarthritis and obesity, discusses current key challenges and ongoing hypotheses arising from research in these areas, and finally, postulates what the future may hold in terms of new horizons for obese patients with osteoarthritis.

Originalsprog Engelsk
Tidsskrift Obesity reviews : an official journal of the International Association for the Study of Obesity
Vol/bind 15
Udgave nummer 7
Sider (fra-til) 578-86
Antal sider 9
ISSN 1467-7881
DOI
Status Udgivet - jul. 2014

Outcomes of fenestrated endovascular repair of juxtarenal aortic aneurysm

Kristmundsson, T., Sonesson, B., Dias, N., Törnqvist, P., Malina, M. & Resch, T., jan. 2014, I: Journal of Vascular Surgery. 59, 1, s. 115-20 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Polymorphisms in the Inflammatory Pathway Genes TLR2, TLR4, TLR9, LY96, NFKBIA, NFKB1, TNFA, TNFRSF1A, IL6R, IL10, IL23R, PTPN22, and PPARG Are Associated with Susceptibility of Inflammatory Bowel Disease in a Danish Cohort

Bank, S., Skytt Andersen, P., Burisch, J., Pedersen, N., Roug, S., Galsgaard, J., Turino, S. Y., Broder Brodersen, J., Rashid, S., Kaiser Rasmussen, B., Avlund, S., Bastholm Olesen, T., Jürgen Hoffmann, H., Kragh Thomsen, M., Ostergaard Thomsen, V., Frydenberg, M., Andersen Nexø, B., Sode, J., Vogel, U. & Andersen, V., 2014, I: P L o S One. 9, 6, s. e98815

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: The inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), result from the combined effects of susceptibility genes and environmental factors. Polymorphisms in genes regulating inflammation may explain part of the genetic heritage.

METHODS: Using a candidate gene approach, 39 mainly functional single nucleotide polymorphisms (SNPs) in 26 genes regulating inflammation were assessed in a clinical homogeneous group of severely diseased patients consisting of 624 patients with CD, 411 patients with UC and 795 controls. The results were analysed using logistic regression.

RESULTS: Sixteen polymorphisms in 13 genes involved in regulation of inflammation were associated with risk of CD and/or UC (p≤0.05). The polymorphisms TLR2 (rs1816702), NFKB1 (rs28362491), TNFRSF1A (rs4149570), IL6R (rs4537545), IL23R (rs11209026) and PTPN22 (rs2476601) were associated with risk of CD and the polymorphisms TLR2 (rs1816702), TLR4 (rs1554973 and rs12377632), TLR9 (rs352139), LY96 (rs11465996), NFKBIA (rs696), TNFA (rs1800629), TNFRSF1A (rs4149570), IL10 (rs3024505), IL23R (rs11209026), PTPN22 (rs2476601) and PPARG (rs1801282) were associated with risk of UC. When including all patients (IBD) the polymorphisms TLR2 (rs4696480 and rs1816702), TLR4 (rs1554973 and rs12377632), TLR9 (rs187084), TNFRSF1A (rs4149570), IL6R (rs4537545), IL10 (rs3024505), IL23R (rs11209026) and PTPN22 (rs2476601) were associated with risk. After Bonferroni correction for multiple testing, both the homozygous and the heterozygous variant genotypes of IL23R G>A(rs11209026) (ORCD,adj: 0.38, 95% CI: 0.21-0.67, p = 0.03; ORIBD,adj 0.43, 95% CI: 0.28-0.67, p = 0.007) and PTPN22 1858 G>A(rs2476601) (ORCD,unadj 0.54, 95% CI: 0.41-0.72, p = 7*10-4; ORIBD,unadj: 0.61, 95% CI: 0.48-0.77, p = 0.001) were associated with reduced risk of CD.

CONCLUSION: The biological effects of the studied polymorphisms suggest that genetically determined high inflammatory response was associated with increased risk of CD. The many SNPs found in TLRs suggest that the host microbial composition or environmental factors in the gut are involved in risk of IBD in genetically susceptible individuals.

Originalsprog Engelsk
Tidsskrift P L o S One
Vol/bind 9
Udgave nummer 6
Sider (fra-til) e98815
ISSN 1932-6203
DOI
Status Udgivet - 2014

Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial

Villadsen, A., Overgaard, S., Holsgaard-Larsen, A., Christensen, R. & Roos, E. M., jun. 2014, I: Annals of the Rheumatic Diseases. 73, 6, s. 1130-7 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To investigate the postoperative efficacy of a supervised programme of neuromuscular exercise prior to hip or knee arthroplasty.

METHODS: In this assessor-blinded randomised controlled trial, we included 165 patients scheduled for hip or knee arthroplasty due to severe osteoarthritis (OA). An 8-week preoperative neuromuscular supervised exercise programme was delivered twice a week for 1 h as adjunct treatment to the standard arthroplasty procedure and compared with the standard arthroplasty procedure alone. The primary outcome was self-reported physical function measured on the activities of daily living (ADL) subscale in the Hip disability and Osteoarthritis Outcome Score (HOOS) and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires for patients with hip and knee OA, respectively. Primary endpoint was 3 months after surgery.

RESULTS: 165 patients randomised to the two groups were on average 67±8 years, 84 (51%) had hip OA and 92 (56%) were women. 153 patients (93%) underwent planned surgery and were evaluated postoperatively. There was no statistically significant difference in effects between hip or knee patients (p=0.7370). Three months postoperatively, no difference was found between groups for ADL (4.4, 95% CI -0.8 to 9.5) or pain (4.5, 95% CI -0.8 to 9.9). However, there was a statistically significant difference indicating an effect of exercise over the entire period (baseline to 3-months postoperatively) (p=0.0029).

CONCLUSIONS: Eight weeks of supervised neuromuscular exercise prior to total joint arthroplasty (TJA) of the hip or knee did not confer additional benefits 3 months postoperatively compared with TJA alone. However, the intervention group experienced a statistically significant short-term benefit in ADL and pain, suggesting an earlier onset of postoperative recovery.

TRIAL REGISTRATION: ClinicalTrials NCT01003756.

Originalsprog Engelsk
Tidsskrift Annals of the Rheumatic Diseases
Vol/bind 73
Udgave nummer 6
Sider (fra-til) 1130-7
Antal sider 8
ISSN 0003-4967
DOI
Status Udgivet - jun. 2014

Preferences of patients and health professionals for route and frequency of administration of biologic agents in the treatment of rheumatoid arthritis

Huynh, T. K., Ostergaard, A., Egsmose, C. & Madsen, O. R., 2014, I: Patient Preference and Adherence. 8, s. 93-9 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

To examine the preferences of rheumatoid arthritis (RA) patients and health professionals (HPs) for the route and frequency of administration of biologic drugs.
Originalsprog Engelsk
Tidsskrift Patient Preference and Adherence
Vol/bind 8
Sider (fra-til) 93-9
Antal sider 7
ISSN 1177-889X
DOI
Status Udgivet - 2014

Psychometric evaluation of the Danish version of Satisfaction with Daily Occupations (SDO)

Eklund, M. & Morville, A-L., maj 2014, I: Scandinavian Journal of Occupational Therapy. 21, 3, s. 166-71 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

AIMS: The Satisfaction with Daily Occupations (SDO) scale assesses satisfaction within the domains of work, leisure, domestic tasks, and self-care. The aim was to investigate the psychometric properties of the Danish version of the SDO when used with asylum seekers.

METHODS: The participants were 93 Danes without known ill health and 43 asylum seekers. They completed the SDO and rated their perceived health, activity level, and general satisfaction with daily occupations. Translation into Danish and back-translation into Swedish was made by professional interpreters.

RESULTS: Internal consistency was α = 0.75 for the Danish sample and α = 0.79 for the asylum seekers. The SDO distinguished between asylum seekers and the Danish sample, suggesting criterion validity. Concurrent validity, analysed against general satisfaction with daily occupations, was indicated for both samples. Discriminant validity was indicated against self-rated health for both samples and against activity level for the Danish sample. There was, however, a correlation of 0.65 between the SDO satisfaction score and activity level for the asylum seekers.

CONCLUSION: The SDO exhibited satisfactory internal consistency and criterion and concurrent validity. The findings regarding discriminant validity were somewhat inconclusive. The Danish SDO may be regarded as psychometrically sound but further psychometric testing is needed.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
Vol/bind 21
Udgave nummer 3
Sider (fra-til) 166-71
Antal sider 6
ISSN 1103-8128
DOI
Status Udgivet - maj 2014

Quick diagnostic unit integrated in an emergency department setting reduces medical admissions – an observational study

Petersen, D. B. & Schmidt, T. A., 2014, I: Journal of Hospital administration. 3, 3, 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Response to Hitman. Insulin degludec: a new insulin for today?

Schmidt, T. A., mar. 2014, I: Diabetic medicine : a journal of the British Diabetic Association. 31, 3, s. 377-8 2 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskning

Results of F-EVAR in octogenarians

Hertault, A., Sobocinski, J., Kristmundsson, T., Maurel, B., Dias, N. V., Azzaoui, R., Sonesson, B., Resch, T. & Haulon, S., aug. 2014, I: Annals of Vascular Surgery. 28, 6, s. 1396-401 6 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: To determine whether study sponsor, chemical formulation, brand of glucosamine, and/or risk of bias explain observed inconsistencies in trials of glucosamine's efficacy for treating pain in osteoarthritis (OA).

METHODS: A systematic review and stratified meta-analysis of randomized placebo-controlled trials was performed, and random-effects models were applied with inconsistency (I(2) ) and heterogeneity (tau(2) ) estimated using Review Manager and SAS, respectively. The major outcome was reduction of pain; the standardized mean difference (SMD [95% confidence interval (95% CI)]) served as effect size.

RESULTS: The inclusion criteria yielded 25 trials (3,458 patients). Glucosamine moderately reduced pain (SMD -0.51 [95% CI -0.72, -0.30]), although a high level of between-trial inconsistency was observed (I(2) = 88%). The single most important explanation (i.e., covariate) was brand, reducing heterogeneity by 41% (P = 0.00032). Twelve trials (1,437 patients) using the Rottapharm/Madaus product resulted in significant pain reduction (SMD -1.07 [95% CI -1.47, -0.67]), although a sensitivity analysis of 3 low risk of bias trials using the Rottapharm/Madaus product showed less promising results (SMD -0.27 [95% CI -0.43, -0.12]), which is only a small effect size. Thirteen trials (1,963 patients) using non-Rottapharm/Madaus products consistently failed to show a reduction in pain (SMD -0.11 [95% CI -0.46, 0.24]). The second most important explanation was overall risk of bias (reducing heterogeneity by 32%).

CONCLUSION: Most of the observed heterogeneity in glucosamine trials is explained by brand. Trials using the Rottapharm/Madaus glucosamine product had a superior outcome on pain in OA compared to other preparations of glucosamine. Large inconsistency was found, however. Low risk of bias trials, using the Rottapharm/Madaus product, revealed a small effect size.

Originalsprog Engelsk
Tidsskrift Arthritis Care & Research
Vol/bind 66
Udgave nummer 12
Sider (fra-til) 1844-55
Antal sider 12
ISSN 2151-464X
DOI
Status Udgivet - dec. 2014

Role of vesicular nucleotide transporter VNUT (SLC17A9) in release of ATP from AR42J cells and mouse pancreatic acinar cells

Haanes, K. A., Kowal, J. M., Arpino, G., Lange, S. C., Moriyama, Y., Pedersen, P. A. & Novak, I., sep. 2014, I: Purinergic Signalling. 10, 3, s. 431-440 10 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Rygestopbasens Årsrapport 2014: Aktiviteter afholdt i 2014 samt 2013 med opfølgning i 2014

Rasmussen, M., Vilholt, S. & Tønnesen, H., 2014

Publikation: Bog/antologi/afhandling/rapportRapportFormidling

Originalsprog Engelsk
Status Udgivet - 2014
Originalsprog Engelsk
Forlag Clinical Health Promotion
Vol/bind 4
Udgave 2
Status Udgivet - 2014

Self-reported quality of ADL task performance among patients with COPD exacerbations

Bendixen, H. J., Wæhrens, E. E., Wilcke, J. T. & Sørensen, L. V., jul. 2014, I: Scandinavian Journal of Occupational Therapy. 21, 4, s. 313-20 8 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: Patients suffering from chronic obstructive pulmonary disease (COPD) experience problems in the performance of activities of daily living (ADL) tasks. The objective was to examine the self-reported quality of ADL task performance among COPD patients, and to investigate whether age, gender, and routine COPD characteristics correlate with the self-reported ADL ability.

METHODS: Eighty patients admitted to hospital with COPD exacerbations participated. In a cross-sectional study, the patients' self-reported ADL ability was assessed using the ADL-Interview (ADL-I) instrument. Data concerning age, gender, and routine COPD characteristics were drawn from the patients' medical records.

RESULTS: The patients reported being inefficient to markedly inefficient when performing ADL tasks within the personal hygiene, toileting, dressing, household, mobility, and transportation domains. While more than 90% of the participants reported increased effort and/or fatigue when performing the ADL tasks, up to 88% of the participants relied on help from others in the performance of general household chores like cooking and shopping. Self-reported ADL ability did not correlate with age, gender, or routine COPD characteristics.

CONCLUSIONS: Decreased quality of ADL task performance seemed to be extremely common among COPD patients. Therefore, addressing the problems in individually tailored pulmonary rehabilitation programmes may be advantageous.

Originalsprog Engelsk
Tidsskrift Scandinavian Journal of Occupational Therapy
Vol/bind 21
Udgave nummer 4
Sider (fra-til) 313-20
Antal sider 8
ISSN 1103-8128
DOI
Status Udgivet - jul. 2014

Soluble urokinase plasminogen activator receptor is in contrast to high-sensitive C-reactive-protein associated with coronary artery calcifications in healthy middle-aged subjects

Sørensen, M. H., Gerke, O., Eugen-Olsen, J., Munkholm, H., Lambrechtsen, J., Sand, N. P. R., Mickley, H., Rasmussen, L. M., Olsen, M. H. & Diederichsen, A., nov. 2014, I: Atherosclerosis. 237, 1, s. 60-6 7 s.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

OBJECTIVE: The main objective of this study was to investigate the association between two markers of low-grade inflammation; soluble urokinase plasminogen activator receptor (suPAR) and high-sensitive C-reactive protein (hs-CRP); and coronary artery calcification (CAC) score detected by cardiac computed tomography (CT) scan.

DESIGN: A cross sectional study of 1126 randomly sampled middle-aged men and women.

METHODS: CAC score was measured by a non-contrast cardiac CT scan and total 10-year cardiovascular mortality risk was estimated using the Systematic Coronary Risk Evaluation (SCORE). Plasma samples were analysed for suPAR and hs-CRP. The association of suPAR and hs-CRP to CAC was evaluated by logistic regression analyses adjusting for categorised SCORE. The additive effect of suPAR to SCORE was evaluated by comparing area under curve (AUC) and net reclassification improvement (NRI).

RESULTS: The odds of being in a higher CAC category, i.e. having more severe CAC, increased 16% (odds ratio (OR) 1.16, p = 0.02) when plasma suPAR concentration increased 1 ng/ml, and this was more pronounced in women (OR 1.30, p = 0.01) than in men (OR 1.15, p = 0.05). In comparison, hs-CRP was not associated with CAC category (OR 1.00, p = 0.90). When adding suPAR to categorised SCORE, AUC increased from 0.66 to 0.70 (p = 0.04) in women and from 0.65 to 0.68 (p = 0.03) in men. NRI was significant in men (NRI 19.3%, 95% CI 6.1-32.6, p = 0.004) as well as in women (NRI 20.8%, 95%CI 1.0-40.7, p = 0.04), without significant gender difference.

CONCLUSIONS: suPAR, but not hs-CRP, appeared to be associated with CAC score independently of SCORE. The association was strongest in women.

Originalsprog Engelsk
Tidsskrift Atherosclerosis
Vol/bind 237
Udgave nummer 1
Sider (fra-til) 60-6
Antal sider 7
ISSN 0021-9150
DOI
Status Udgivet - nov. 2014

Our objective was to investigate the efficacy of "energy/spiritual healing" in rheumatoid arthritis (RA). Eligible patients were women with RA on stable medication. The design was a randomised, blinded, sham-controlled trial; the third group included an external unblinded control of the natural course of RA. Participants in both groups received 8 sessions with "perceived healing" over 21 weeks with 8 weeks of follow-up. Active healing (AH) treatment comprised healing with no physical contact, and sham healing (SH) included exactly the same healing with a sham healer. During intervention, participants wore hearing protectors and were blindfolded. No healing (NH) only had their outcomes assessed. Coprimary outcomes were disease activity score (DAS) for 28 joints and Doppler ultrasound. All 96 patients randomised were handled as the intention-to-treat population, using a baseline-carried forward approach to replace the missing data. Eighty-two (85%) participants completed the 29-week trial. At end point (week 29), mean difference in DAS28 between AH versus SH was statistically but not clinically significant in favour of AH (0.62 DAS28 points; 95% CI: 0.13 to 1.11; P = 0.014), while no differences between groups occurred in Doppler ultrasound. There are no clear physiological or psychological explanations for the findings in this tightly controlled study. The trial data indicates a need for independent replication.

Originalsprog Engelsk
Tidsskrift Evidence-based complementary and alternative medicine : eCAM
Vol/bind 2014
Sider (fra-til) 269431
ISSN 1741-427X
DOI
Status Udgivet - 2014

OBJECTIVE: To compare structural knee joint changes in obese patients with knee osteoarthritis (OA) that after an intensive weight loss therapy were randomized to continuous dietetic support, a specialized knee exercise program, or 'no attention' for 1 year.

METHODS: 192 obese individuals with knee OA underwent an intensive 16-week weight loss program with subsequent randomization to one of the three treatment groups. Changes in cartilage loss, bone marrow lesions (BMLs), synovitis, and effusion were assessed using semi quantitative assessments of magnetic resonance imaging (MRI) obtained at weeks 0 and 68 applying the BLOKS score.

RESULTS: During the 52 weeks maintenance period the continuous dietary maintenance group support on average gained 1.1 kg (95% CI: -0.3:2.5) body mass, the exercise group gained 6.6 kg (95% CI 5.4:7.8) and the no-attention group gained 4.8 kg (95% CI: 2.9:6.7). There were no statistically significant between-group differences in changes in cartilage loss, synovitis or effusion at the follow-up (analysis of covariance; ANCOVA, P > 0.16), while there was an increased number of medial tibiofemoral BMLs in the exercise group (ANCOVA, P = 0.015) compared to both diet (difference: -0.21 [95%CI -0.40:-0.03]) and "no attention" (difference: -0.26 [95%CI -0.44:-0.07]) groups.

CONCLUSION: In this 1 year follow-up after weight-loss in obese knee OA patients, we found a potentially increased number of BMLs in the exercise group compared to the diet and no attention groups, with no between-group differences in changes in cartilage loss, synovitis or effusion. These findings should be interpreted with caution for exercise compliance, MRI methodology and follow-up time. (ClinicalTrials.gov identifier: NCT00655941).

Originalsprog Engelsk
Tidsskrift Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Vol/bind 22
Udgave nummer 5
Sider (fra-til) 639-46
Antal sider 8
ISSN 1063-4584
DOI
Status Udgivet - maj 2014

Synovial explant inflammatory mediator production corresponds to rheumatoid arthritis imaging hallmarks: a cross-sectional study

Andersen, M., Boesen, M., Ellegaard, K., Christensen, R., Söderström, K., Søe, N., Spee, P., Mørch, U. G., Torp-Pedersen, S., Bartels, E. M., Danneskiold-Samsøe, B., Vendel, N., Karlsson, L. & Bliddal, H., 2014, I: Arthritis Research & Therapy. 16, 3, s. R107

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

INTRODUCTION: Despite the widespread use of magnetic resonance imaging (MRI) and Doppler ultrasound for the detection of rheumatoid arthritis (RA) disease activity, little is known regarding the association of imaging-detected activity and synovial pathology. The purpose of this study was to compare site-specific release of inflammatory mediators and evaluate the corresponding anatomical sites by examining colour Doppler ultrasound (CDUS) and MRI scans.

METHODS: RA patients were evaluated on the basis of CDUS and 3-T MRI scans and subsequently underwent synovectomy using a needle arthroscopic procedure of the hand joints. The synovial tissue specimens were incubated for 72 hours, and spontaneous release of monocyte chemoattractant protein 1 (MCP-1), interleukin 6 (IL-6), macrophage inflammatory protein 1β (MIP-1β) and IL-8 was measured by performing multiplex immunoassays. Bone marrow oedema (BME), synovitis and erosion scores were estimated on the basis of the rheumatoid arthritis magnetic resonance imaging score (RAMRIS). Mixed models were used for the statistical analyses. Parsimony was achieved by omitting covariates with P > 0.1 from the statistical model.

RESULTS: Tissue samples from 58 synovial sites were obtained from 25 patients. MCP-1 was associated with CDUS activity (P = 0.009, approximate Spearman's ρ = 0.41), RAMRIS BME score (P = 0.01, approximate Spearman's ρ = 0.42) and RAMRIS erosion score (P = 0.03, approximate Spearman's ρ = 0.31). IL-6 was associated with RAMRIS synovitis score (P = 0.04, approximate Spearman's ρ = 0.50), BME score (P = 0.04, approximate Spearman's ρ = 0.31) and RAMRIS erosion score (P = 0.03, approximate Spearman's ρ = 0.35). MIP-1β was associated with CDUS activity (P = 0.02, approximate Spearman's ρ = 0.38) and RAMRIS synovitis scores (P = 0.02, approximate Spearman's ρ = 0.63). IL-8 associations with imaging outcome measures did not reach statistical significance.

CONCLUSIONS: The association between imaging activity and synovial inflammatory mediators underscores the high sensitivity of CDUS and MRI in the evaluation of RA disease activity. The associations found in our present study have different implications for synovial mediator releases and corresponding imaging signs. For example, MCP-1 and IL-6 were associated with both general inflammation and bone destruction, in contrast to MIP-1β, which was involved solely in general synovitis. The lack of association of IL-8 with synovitis was likely underestimated because of a large proportion of samples above assay detection limits among the patients with the highest synovitis scores.

Originalsprog Engelsk
Tidsskrift Arthritis Research & Therapy
Vol/bind 16
Udgave nummer 3
Sider (fra-til) R107
ISSN 1478-6354
DOI
Status Udgivet - 2014

The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial)

Clausen, B., Holsgaard-Larsen, A., Søndergaard, J., Christensen, R., Andriacchi, T. P. & Roos, E. M., 2014, I: Trials. 15, s. 444

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

BACKGROUND: Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis.

METHOD/DESIGN: One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life.

DISCUSSION: These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load, pain and physical function in people with mild to moderate knee osteoarthritis.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012).

Originalsprog Engelsk
Tidsskrift Trials
Vol/bind 15
Sider (fra-til) 444
ISSN 1745-6215
DOI
Status Udgivet - 2014

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