The (cost-)effectiveness of combined lifestyle interventions for people with persistent low-back pain who are overweight or obese: A systematic review.

INTRODUCTION: Lifestyle factors are expected to contribute to the persistence and burden of low-back pain (LBP). However, there are no systematic reviews on the (cost-)effectiveness of combined lifestyle interventions for overweight or obese people with LBP. AIM: To assess whether combined lifestyle interventions are (cost-)effective for people with persistent LBP who are overweight or obese, based on a systematic review. DESIGN: Systematic review METHOD: PubMed, Cochrane, Embase, CINAHL, PsycINFO and the Wiley/Cochrane Library were searched from database inception till January 6th 2023. Two independent reviewers performed study selection, data-extraction and risk of bias scoring using the Cochrane RoB tool 2 and/or the Consensus Health Economic Criteria list. GRADE was used to assess the level of certainty of the evidence. RESULTS: In total 2510 records were screened, and 4 studies on 3 original RCTs with 216 participants were included. Low certainty evidence (1 study) showed that combined lifestyle interventions were not superior to usual care for physical functioning, pain and lifestyle outcomes. Compared to usual care, moderate certainty evidence showed that healthcare (-$292, 95%CI: 872; -33), medication (-$30, 95% CI -65; -4) and absenteeism costs (-$1000, 95%CI: 3573; -210) were lower for the combined lifestyle interventions. CONCLUSION: There is low certainty evidence from 3 studies with predominantly small sample sizes, short follow-up and low intervention adherence that combined lifestyle interventions are not superior to physical functioning, pain and lifestyle outcomes compared to usual care, but are likely to be cost-effective.

Does pain medication influence outcomes in elderly people seeking care for back pain? BACE cohort study.

BACKGROUND: Back pain is common among older adults resulting in the high societal and economic burden of persistent pain and disability. Pain medications are frequently prescribed for back pain, especially among older patients, but the efficacy of analgesics on back pain in this patient population remains under debate. In the present study, we investigated the outcomes (i.e. pain intensity and disability) of pain medication use in older people with back pain participating in a prospective cohort study. METHODS: A total of 669 patients aged >55 years consulting a general practitioner for a new episode of back complaints were included in this study. The association between pain medication use and outcomes (pain intensity and disability) was assessed at 3-month follow-up. RESULTS: Pain medication users were observed to experience more pain and disability at baseline compared with non-users. At 3-month follow-up, patients from all subgroups (e.g. pain medication users versus non-users) improved over time. Yet medication users had higher pain intensity and poorer disability scores compared with non-users. Patients who de-escalated or stopped pain medication had lower pain and disability than non-users. When comparing different types of medications (i.e. paracetamol, non-steroidal anti-inflammatory drugs, opioids), none of the groups showed better scores regarding pain and disability in users compared with non-users. Opioid users displayed the highest levels of pain and disability. CONCLUSIONS: In the present study, although patients who de-escalated or stopped analgesics had less pain and disability, pain medication overall does not result in better outcomes in older people with back pain. SIGNIFICANCE: Older patients taking pain medication did not report better outcomes than the ones who did not, except for those who de-escalated or stopped pain medication. Caution should be taken in prescribing pain medication for older patients with back pain in primary care.

Diagnostic ultrasound in patients with shoulder pain: An inter-examiner agreement and reliability study among Dutch physical therapists.

STUDY DESIGN: A cross-sectional inter-examiner agreement and reliability study among physical therapists in primary care. BACKGROUND: musculoskeletal ultrasound (MSU) is frequently used by physical therapists to improve specific diagnosis in patients with shoulder pain, especially for the diagnosis rotator cuff tendinopathy (RCT) including tears. OBJECTIVES: To estimate the inter-examiner agreement and reliability in physical therapists using MSU for patients with shoulder pain. METHODS: Physical therapists performed diagnostic MSU in 62 patients with shoulder pain. Both physical therapists were blinded to each other's results and patients were not informed about the test results. We calculated the overall inter-examiner agreement, specific positive and negative inter-examiner agreement, and inter-examiner reliability (Cohen's Kappa's). RESULTS: Overall agreement for detecting RC ruptures ranged from 61.7% to 85.5% and from 43.9% to 91.4% for specific positive agreement. The specific negative agreement was lower with values ranging from 44.4% to 79.1% for RC ruptures. Overall agreement for other pathology than ruptures related to SAPS, ranged from 72.6% to 93.6% and from 77.3% to 96% for specific positive agreement. The specific negative agreement was lower with values ranging from 44.4% to 79.1% for RC ruptures and 52.5%-83.3% for other pathology than ruptures related to SAPS. Reliability values varied from substantial for any thickness ruptures to moderate for partial thickness ruptures and fair for full thickness tears. Moreover, reliability was fair for cuff tendinopathy. The reliability for AC arthritis and no pathology found was fair and moderate. There was substantial agreement for the calcifying tendinopathy. CONCLUSIONS: Physical therapists using MSU agree on the diagnosis of cuff tendinopathy and on the presence of RCT in primary care, but agree less on the absence of pathology.

Recovery expectations of neck pain patients do not predict treatments outcome in manual therapy.

Patient recovery expectations can predict treatment outcome. Little is known about the association of patient recovery expectations on treatment outcome in patients with neck pain consulting a manual therapist. This study evaluates the predictive value of recovery expectations in neck pain patients consulting manual therapists in the Netherlands. The primary outcome measure 'recovery' is defined as 'reduction in pain and perceived improvement'. A prospective cohort study a total of 1195 neck pain patients. Patients completed the Patient Expectancies List (PEL) at baseline (3 item questionnaire, score range from 3 to 12), functional status (NDI), the Global Perceived Effect (GPE) for recovery (7-points Likert scale) post treatment and pain scores (NRS) at baseline and post treatment. The relationship between recovery expectancy and recovery (dichotomized GPE scores) was assessed by logistic regression analysis. Patients generally reported high recovery expectations on all three questions of the PEL (mean sumscores ranging from 11.3 to 11.6). When adjusted for covariates the PEL sum-score did not predict recovery (explained variance was 0.10 for the total PEL). Separately, the first question of the PEL showed predictive potential (OR 3.7; 95%CI 0.19-73.74) for recovery, but failed to reach statistical significance. In this study patient recovery expectations did not predict treatment outcome. Variables predicting recovery were recurrence and duration of pain. The precise relationship between patient recovery expectations and outcome is complex and still inconclusive. Research on patient expectancy would benefit from more consistent use of theoretical expectancy and outcome models.

Comparing the range of musculoskeletal therapies applied by physical therapists with postgraduate qualifications in manual therapy in patients with non-specific neck pain with international guidelines and recommendations: An observational study.

The aim of this study is to compare Dutch usual care musculoskeletal therapy in patients with non-specific neck pain with recommendations from international clinical practice guidelines. Physical therapy is diverse, as it may consist of exercise, massage, advice, and other modalities. Physical therapists with post graduate qualifications in manual therapy (MT) may additionally apply spinal thrust manipulation or non-thrust mobilization techniques to treat neck pain. It is important that, in the absence of a Dutch clinical guideline for the treatment of patients with neck pain, musculoskeletal therapists use the available recommendations from international clinical practice guidelines when treating patients with neck pain. One updated clinical practice guideline was identified (Blanpied, 2017), a report from the Task Force on Neck Pain (Guzman et al., 2008) and the IFOMPT International Framework for Examination of the Cervical Region for potential of Cervical Arterial Dysfunction prior to Orthopaedic Manual Therapy Intervention (Rushton et al., 2014). At baseline 1193 patients are included and data with regard to pain, disability, fear avoidance, expectations and applied treatment modalities are gathered. Outcome is measured using the Global Perceived Effect questionnaire. Results show that patients with acute neck pain are treated significantly more often with manipulation compared to patients with sub-acute or chronic neck pain (p < .000) and younger patients are treated with manipulation more often than older patients (p < .000). In the presence of comorbidity, the preference of spinal manipulation seems to diminish, in favour of mobilization and exercise. Almost every patient receives multimodal therapy (94.3%) and spinal manipulation and mobilization are rarely used as a stand-alone treatment (4.5% and 0.8%). Dutch musculoskeletal therapists choose treatment strategies that correspond with recommendations from international guidelines.

Comparison of three sets of clinical classification criteria for knee osteoarthritis: a cross-sectional study of 13,459 patients treated in primary care.

OBJECTIVE: To determine and compare the proportion of patients treated in a primary care setting that have knee osteoarthritis (OA) according to the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR), and the National Institute for Health and Care Excellence (NICE) clinical classification criteria. DESIGN: A cross-sectional analysis of baseline data from 13,459 patients with knee symptoms or functional limitations associated with OA participating in the Good Life with osteoArthritis in Denmark (GLA:D®) treatment program. The prevalence of knee OA according to the EULAR, ACR and NICE criteria were calculated in all participants and in the subgroup of patients with self-reported radiographic changes associated with knee OA (n = 10,651 or 79%). RESULTS: Mean age (SD) was 65.3 (9.8) years, median (IQR) duration of symptoms 12 (6-36) months and mean pain intensity (0-100; SD) 46.5 (22.1) mm. 39% fulfilled all three sets of criteria. 48%, 52% and 89% fulfilled the EULAR, ACR, and NICE criteria for having knee OA, respectively. In the subgroup with self-reported radiographic changes, the corresponding numbers were 49%, 54% and 90%. CONCLUSIONS: While the EULAR and ACR criteria only identified around half of those, with or without self-reported radiographic knee OA, that were treated because of symptoms or functional limitations associated with knee OA, the NICE criteria identified most patients. The results indicate that the NICE criteria are relevant and appropriate to identify individuals treated for knee OA in primary care.

Agreement between physical therapists and radiologists of stratifying patients with shoulder pain into new treatment related categories using ultrasound; an exploratory study.

STUDY DESIGN: A systematic overview of the literature and an agreement study. OBJECTIVES: The aim of this study is to explore the inter-professional agreement of diagnostic musculoskeletal ultrasound (DMUS) between physical therapists (PT) and radiologists, using a new classification strategy based upon the therapeutic consequences in patients with shoulder pain. BACKGROUND: DMUS is frequently used by PTs, although the agreement regarding traditional diagnostic labels between PTs and radiologists is only fair. Nevertheless, DMUS could be useful when used as a stratifying-tool. METHODS: First, a systematic overview of current evidence was performed to assess which traditional diagnostic labels could be recoded into new treatment related categories (referral to secondary care, corticosteroid injections, physical therapy, watchful waiting). Next, kappa values were calculated for these categories between PTs and radiologists. RESULTS: Only three categories were extracted, as none of the traditional diagnostic labels were classified into the 'corticosteroid injection' category. Overall, we found moderate agreement to stratify patients into treatment related categories and substantial agreement for the category 'referral to secondary care'. Both categories 'watchful waiting' and 'indication for physical therapy' showed moderate agreement between the two professions. CONCLUSION: Our results indicate that the agreement between radiologists and PTs is moderate to substantial when labelling is based on treatment consequences. DMUS might be able to help the PT to guide treatment, especially for the category 'referral to secondary care' as this showed the highest agreement. However, as this is just an explorative study, more research is needed, to validate and assess the consequences of this stratification classification for clinical care.

The association between pro-inflammatory biomarkers and nonspecific low back pain: a systematic review.

BACKGROUND CONTEXT: About 85% of the patients with low back pain seeking medical care have nonspecific low back pain (NsLBP), implying that no definitive cause can be identified. Nonspecific low back pain is defined as low back pain and disability which cannot be linked to an underlying pathology, such as cancer, spinal osteomyelitis, fracture, spinal stenosis, cauda equine, ankylosing spondylitis, and visceral-referred pain. Many pain conditions are linked with elevated serum levels of pro-inflammatory biomarkers. Outcomes of interest are NsLBP and the level of pro-inflammatory biomarkers. PURPOSE: To unravel the etiology and get better insight in the prognosis of NsLBP, the aim of this study was to assess the association between pro-inflammatory biomarkers and the presence and severity of NsLBP. STUDY DESIGN: A systematic literature search was made in Embase, Medline, Cinahl, Webof-science, and Google scholar up to January 19th 2017. METHODS: Included were cross-sectional and cohort studies reporting on patients aged over 18 years with NsLBP, in which one or more pro-inflammatory biomarkers were measured in blood plasma. The methodological quality of the included studies was assessed using the Newcastle Ottawa Scale. A best-evidence synthesis was used to summarize the results from the individual studies, meaning that the included studies were ranked according to the consistency of the findings and according to their methodological quality score using the Newcastle Ottawa Scale. RESULTS: Included were 10 studies which assessed four different pro-inflammatory biomarkers. For the association between the presence of NsLBP and C-reactive protein (CRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF)-α limited, conflicting and moderate evidence, respectively, was found. For the association between the severity of NsLBP and CRP and IL-6, moderate evidence was found. For the association between the severity of NsLBP and TNF-α and RANTES Regulated on Activation, Normal T Cell Expressed and Secreted conflicting and limited evidence, respectively, was found. CONCLUSIONS: This study found moderate evidence for (i) a positive association between the pro-inflammatory biomarkers CRP and IL-6 and the severity of NsLBP, and (ii) a positive association between TNF-α and the presence of NsLBP. Conflicting and limited evidence was found for the association between TNF-α and Regulated on Activation, Normal T Cell Expressed and Secreted and severity of NsLBP, respectively.

Discontinuation of the PACE Plus trial: problems in patient recruitment in general practice.

BACKGROUND: The PACE Plus trial was a multi-center, double-blinded, superiority randomized controlled trial (RCT) conducted in patients from Dutch general practice to investigate the efficacy of paracetamol and NSAIDs in acute non-specific low back pain (LBP). Because insufficient numbers of patients could be recruited (only four out of the required 800 patients could be recruited over a period of 6 months), the trial was prematurely terminated in February 2017, 6 months after the start of recruitment. This article aims to transparently communicate the discontinuation of PACE Plus and to make recommendations for future studies. METHODS: General Practitioners (GPs) from 36 participating practices received a one-question survey in which they were asked to give the three most important factors that in their opinion contributed to failure of patient recruitment. RESULTS: GPs of 33 out of 36 (92%) participating practices sent a response. A total of 81 factors were reported. These have been categorized into patient factors (26 out of 81 comments, 32%), GP factors (39 out of 81 comments, 48%) and research factors (16 out of 81 comments, 20%). DISCUSSION: Patient recruitment in the PACE Plus trial may have failed due to inefficient medication distribution, recruitment of incident rather than prevalent cases, a design that was too complicated, adequate self-management of LBP, patient expectations different from the trial's scope and lack of time of participating GPs. Substantial differences in design may explain why the preceding PACE trial did manage to successfully complete patient recruitment. CONCLUSION: Although the PACE Plus trial was terminated as a result of insufficient patient inclusion, the research questions addressed in this trial remain relevant but unanswered. We hope that lessons learned from the discontinuation of PACE Plus and corresponding recommendations may be helpful in the design of upcoming research projects in LBP in general practice. TRIAL REGISTRATION: Dutch Trial Registration NTR6089, registered September 14th 2016.

[Can sick leave be predicted in patients with non-traumatic arm, neck and/or shoulder complaints?] / Is ziekteverzuim bij arm-, nek-, en/of schouderklachten te voorspellen?

OBJECTIVES: Impediments due to complaints of non-traumatic arm, neck and/or shoulder (CANS) during work often leads to consultation in primary care. This study examines the occurrence of sick leave among workers with new CANS, and evaluates sick leave trajectories and their characteristics. METHODS: This prospective 2-year cohort study included workers with a new CANS presenting in general practice. Participants filled out postal questionnaires on sick leave at 6-monthly intervals. Latent class growth mixture modelling was used to identify distinct trajectories of sick leave. Multinomial regression analyses identified characteristics of the subgroups. RESULTS: During follow-up, of the 533 participants 190 reported at least one episode of sick leave due to CANS. Three sick leave trajectories were distinguished: (a) 'low risk' trajectory (n = 366), with a constant low probability over time; (b) 'intermediate risk' trajectory, with a high probability at first consultation followed by a steep decrease in probability of sick leave (n = 122); (c) 'high risk' trajectory (n = 45), with a constant high probability of sick leave. Compared to the 'low-risk' trajectory, the other trajectories were characterised by more functional limitations, less specific diagnoses, more work-related symptoms and low coworker support. Specific for the 'high-risk' subgroup were more recurrent symptoms, more musculoskeletal comorbidity, high score on somatisation and low score on job demands. CONCLUSIONS: Three trajectories of sick leave were distinguished, graded from favourable to unfavourable. Several complaint-related and work-related factors and somatisation contributed modestly to identify an unfavourable trajectory of sick leave when presenting in primary care with CANS.

Physiotherapy for patients with shoulder pain in primary care: a descriptive study of diagnostic- and therapeutic management.

BACKGROUND: Shoulder pain is one of the three main musculoskeletal complaints and more than 50% of the patients have symptoms longer than 6 months. Until now, limited data exist about the content of physiotherapy for patients with shoulder pain in primary care. OBJECTIVE: Describe current physiotherapeutic diagnostic- and therapeutic management, including the use of diagnostic ultrasound, in patients with shoulder pain in primary care. DESIGN AND SETTING: A prospective cohort study in primary care physiotherapy with a 12 week follow-up. METHODS: Descriptive data from physiotherapists was collected, such as: the diagnostic hypotheses after patient history and physical examination, the use of specific tests and diagnostic ultrasound, the interventions used and possible changes in treatment plan. RESULTS: Subacromial impingement syndrome was the most common hypothesis after patient history (48%) as well as physical examination (39%). Diagnostic ultrasound was used in 31% and of these patients the clinical diagnosis changed in 29%. Various interventions were used in all clinical diagnoses. After 12 weeks 41% of patients still received physiotherapy treatment. CONCLUSIONS: Patients with shoulder pain in physiotherapy practice frequently show signs of subacromial impingement syndrome. The interventions used by the physiotherapists were generally in line with the guideline for subacromial impingement syndrome however a small proportion of physiotherapists used massage and tape/bracing techniques. A large proportion of patients were still receiving treatment after 12 weeks when no improvement was observed. If treatment for patients with subacromial impingement shows no benefit patients should be referred back to the general practitioner or orthopedic surgeon. Conclusions from this study might be slightly biased because of the selection of physiotherapists.

Differences in bone mineral density between normal-weight children and children with overweight and obesity: a systematic review and meta-analysis.

OBJECTIVE: This study examines the differences in bone mineral density between normal-weight children and children with overweight or obesity. METHODS: A systematic review and meta-analysis of observational studies (published up to 22 June 2016) on the differences in bone mineral density between normal-weight children and overweight and obese children was performed. Results were pooled when possible and mean differences (MDs) were calculated between normal-weight and overweight and normal-weight and obese children for bone content and density measures at different body sites. RESULTS: Twenty-seven studies, with a total of 5,958 children, were included. There was moderate and high quality of evidence that overweight (MD 213 g; 95% confidence interval [CI] 166, 261) and obese children (MD 329 g; 95%CI [229, 430]) have a significantly higher whole body bone mineral content than normal-weight children. Similar results were found for whole body bone mineral density. Sensitivity analysis showed that the association was stronger in girls. CONCLUSIONS: Overweight and obese children have a significantly higher bone mineral density compared with normal-weight children. Because there was only one study included with a longitudinal design, the long-term impact of childhood overweight and obesity on bone health at adulthood is not clear.

Efficacy of paracetamol, diclofenac and advice for acute low back pain in general practice: design of a randomized controlled trial (PACE Plus).

BACKGROUND: Low back pain is common and associated with a considerable burden to patients and society. There is uncertainty regarding the relative benefit of paracetamol and diclofenac and regarding the additional effect of pain medication compared with advice only in patients with acute low back pain. This trial will assess the effectiveness of paracetamol, diclofenac and placebo for acute low back pain over a period of 4 weeks. Furthermore, this trial will assess the additional effectiveness of paracetamol, diclofenac and placebo compared with advice only for acute low back pain over a period of 4 weeks. METHODS: The PACE Plus trial is a multi-center, placebo-blinded, superiority randomized controlled trial in primary care, with a follow-up of 12 weeks. Patients with acute low back pain aged 18-60 years presenting in general practice will be included. Patients are randomized into four groups: 1) Advice only (usual care conforming with the clinical guideline of the Dutch College of General Practitioners); 2) Advice and paracetamol; 3) Advice and diclofenac; 4) Advice and placebo. The primary outcome is low back pain intensity measured with a numerical rating scale (0-10). Secondary outcomes include compliance to treatment, disability, perceived recovery, costs, adverse reactions, satisfaction, sleep quality, co-interventions and adequacy of blinding. Between group differences for low back pain intensity will be evaluated using a repeated measurements analysis with linear effects models. An economic evaluation will be performed using a cost-effectiveness analysis with low back pain intensity and a cost-utility analysis with quality of life. Explorative analyses will be performed to assess effect modification by predefined variables. Ethical approval has been granted. Trial results will be released to an appropriate peer-viewed journal. DISCUSSION: This paper presents the design of the PACE Plus trial: a multi-center, placebo-blinded, superiority randomized controlled trial in primary care that will assess the effectiveness of advice only, paracetamol, diclofenac and placebo for acute low back pain. TRIAL REGISTRATION: Dutch Trial Registration NTR6089 , registered September 14th, 2016. PROTOCOL: Version 4, June 2016.

Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints.

Patient history and physical examination are frequently used procedures to diagnose chronic low back pain (CLBP) originating from the facet joints, although the diagnostic accuracy is controversial. The aim of this systematic review is to determine the diagnostic accuracy of patient history and/or physical examination to identify CLBP originating from the facet joints using diagnostic blocks as reference standard. We searched MEDLINE, EMBASE, CINAHL, Web of Science and the Cochrane Collaboration database from inception until June 2016. Two review authors independently selected studies for inclusion, extracted data and assessed the risk of bias. We calculated sensitivity and specificity values, with 95% confidence intervals (95% CI). Twelve studies were included, in which 129 combinations of index tests and reference standards were presented. Most of these index tests have only been evaluated in single studies with a high risk of bias. Four studies evaluated the diagnostic accuracy of the Revel's criteria combination. Because of the clinical heterogeneity, results were not pooled. The published sensitivities ranged from 0.11 (95% CI 0.02-0.29) to 1.00 (95% CI 0.75-1.00), and the specificities ranged from 0.66 (95% CI 0.46-0.82) to 0.91 (95% CI 0.83-0.96). Due to clinical heterogeneity, the evidence for the diagnostic accuracy of patient history and/or physical examination to identify facet joint pain is inconclusive. Patient history and physical examination cannot be used to limit the need of a diagnostic block. The validity of the diagnostic facet joint block should be studied, and high quality studies are required to confirm the results of single studies. SIGNIFICANCE: Patient history and physical examination cannot be used to limit the need of a diagnostic block. The validity of the diagnostic facet joint block should be studied, and high quality studies are required to confirm the results of single studies.

Sick leave in workers with arm, neck and/or shoulder complaints; defining occurrence and discriminative trajectories over a 2-year time period.

OBJECTIVES: Impediments due to complaints of non-traumatic arm, neck and/or shoulder (CANS) during work often leads to consultation in primary care. This study examines the occurrence of sick leave among workers with new CANS, and evaluates sick leave trajectories and their characteristics. METHODS: This prospective 2-year cohort study included workers with a new CANS presenting in general practice. Participants filled out postal questionnaires on sick leave at 6-monthly intervals. Latent class growth mixture modelling was used to identify distinct trajectories of sick leave. Multinomial regression analyses identified characteristics of the subgroups. RESULTS: During follow-up, of the 533 participants 190 reported at least one episode of sick leave due to CANS. Three sick leave trajectories were distinguished: (1) 'low-risk' trajectory (n=366), with a constant low probability over time; (2) 'intermediate risk' trajectory, with a high probability at first consultation followed by a steep decrease in probability of sick leave (n=122); (3) 'high-risk' trajectory (n=45), with a constant high probability of sick leave. Compared to the 'low-risk' trajectory, the other trajectories were characterised by more functional limitations, less specific diagnoses, more work-related symptoms and low coworker support. Specific for the 'high-risk' subgroup were more recurrent symptoms, more musculoskeletal comorbidity, high score on somatisation and low score on job demands. CONCLUSIONS: Three trajectories of sick leave were distinguished, graded from favourable to unfavourable. Several complaint-related and work-related factors and somatisation contributed modestly to identify an unfavourable trajectory of sick leave when presenting in primary care with CANS.

Reducing progression of knee OA features assessed by MRI in overweight and obese women: secondary outcomes of a preventive RCT.

OBJECTIVE: To evaluate the preventive effects of a randomized controlled trial on progression of Magnetic Resonance Imaging (MRI) features of knee osteoarthritis (OA) in overweight and obese women. DESIGN: In a 2 × 2 factorial design, 2.5 years effects of a diet and exercise program and of glucosamine sulphate (double-blind, placebo-controlled) were evaluated in 407 middle-aged women with body mass index (BMI) ≥ 27 kg/m(2) without clinical signs of knee OA at baseline (ISRCTN 42823086). MRIs were scored with the MRI Osteoarthritis Knee Score (MOAKS). Progression was defined for bone marrow lesions (BMLs), cartilage defects, osteophytes, meniscal abnormalities and meniscal extrusion. Analyses on knee level were performed over the four intervention groups using adjusted Generalized Estimating Equations (GEE). RESULTS: 687 knees of 347 women with mean age 55.7 years (±3.2 SD) and mean BMI 32.3 kg/m(2) (±4.2 SD) were analyzed. Baseline prevalence was 64% for BMLs, 70% for cartilage defects, 24% for osteophytes, 66% for meniscal abnormalities and 52% for meniscal extrusions. The diet and exercise program + placebo intervention showed significantly less progression of meniscal extrusion compared to placebo only (12% vs 22%, OR 0.50, 95% CI [0.27-0.92]). The interventions did not result in significant differences on other OA MRI features. CONCLUSIONS: In subjects at high risk for future knee OA development, a diet and exercise program, glucosamine sulphate and their combination showed small and mainly non-significant effects on the progression of OA MRI features. Only progression of meniscal extrusion was significantly diminished by the diet and exercise program.

Cost-utility of exercise therapy in patients with hip osteoarthritis in primary care.

OBJECTIVE: To determine the cost-effectiveness (CE) of exercise therapy (intervention group) compared to 'general practitioner (GP) care' (control group) in patients with hip osteoarthritis (OA) in primary care. METHOD: This cost-utility analysis was conducted with 120 GPs in the Netherlands from the societal and healthcare perspective. Data on direct medical costs, productivity costs and quality of life (QoL) was collected using standardised questionnaires which were sent to the patients at baseline and at 6, 13, 26, 39 and 52 weeks follow-up. All costs were based on Euro 2011 cost data. RESULTS: A total of 203 patients were included. The annual direct medical costs per patient were significantly lower for the intervention group (€ 1233) compared to the control group (€ 1331). The average annual societal costs per patient were lower in the intervention group (€ 2634 vs € 3241). Productivity costs were higher than direct medical costs. There was a very small adjusted difference in QoL of 0.006 in favour of the control group (95% CI: -0.04 to +0.02). CONCLUSION: Our study revealed that exercise therapy is probably cost saving, without the risk of noteworthy negative health effects. TRIAL REGISTRATION NUMBER: NTR1462.

Effectiveness of exercise therapy added to general practitioner care in patients with hip osteoarthritis: a pragmatic randomized controlled trial.

OBJECTIVE: To assess the effectiveness of exercise therapy added to general practitioner (GP) care compared with GP care alone, in patients with hip osteoarthritis (OA) during 12 months follow-up. METHODS: We performed a multi-center parallel pragmatic randomized controlled trial in 120 general practices in the Netherlands. 203 patients, aged ≥45 years, with a new episode of hip complaints, complying with the ACR criteria for hip OA were randomized to the intervention group (n = 101; GP care with additional exercise therapy) or the control group (n = 102; GP care only). GP care was given by patient's own GP. The intervention group received, in addition, a maximum of 12 exercise therapy sessions in the first 3 months and hereafter three booster sessions. Blinding was not possible. Primary outcomes were hip pain and hip-related function measured with the HOOS questionnaire (score 0-100). RESULTS: The overall estimates on hip pain and function during the 12-month follow-up showed no between-group difference (intention-to-treat). At 3-months follow-up there was a statistically significant between-group difference for HOOS pain -3.7 (95% CI: -7.3; -0.2), effect size -0.23 and HOOS function -5.3 (95% CI: -8.9; -1.6), effect size -0.31. No adverse events were reported. CONCLUSIONS: No differences were found during 12-months follow-up on pain and function. At 3-months follow-up, pain and function scores differed in favor of patients allocated to the additional exercise therapy compared with GP care alone. TRIAL REGISTRATION: The Netherlands Trial Registry NTR1462.