Weight-Bearing Physical Activity, Lower-Limb Muscle Mass, and Risk of Knee Osteoarthritis.

Importance: It has been demonstrated that total physical activity is not associated with risk of osteoarthritis. However, the association of different types of physical activity with incident knee osteoarthritis remains unclear. Objective: To determine whether weight-bearing recreational physical activities are associated with increased risk of incident knee osteoarthritis. Design, Setting, and Participants: This prospective cohort study used data from the Rotterdam Study (1996 to 2009), including participants with knee x-ray measurements at baseline and follow-up examinations. Participants with knee osteoarthritis at baseline were excluded. Residents aged 45 years and older of the Ommoord district in the city of Rotterdam in The Netherlands were invited to join the Rotterdam Study (78% response rate). Analysis was conducted in June 2023. Exposure: Total, weight-bearing, and non-weight-bearing recreational physical activities collected by questionnaires at baseline. Main Outcomes and Measures: Incident radiographic knee osteoarthritis measured by knee x-ray was the primary outcome, and incident symptomatic knee osteoarthritis defined by x-ray and knee pain questionnaire was the secondary outcome. The association of different types of recreational physical activity with radiographic knee osteoarthritis was examined using logistic regression within generalized estimating equation framework after adjusting for potential confounders. A prespecified stratification analysis was planned on the basis of lower-limb muscle mass index (LMI) tertiles, measured by dual-energy x-ray absorptiometry. Results: A total of 5003 individuals (2804 women [56.0%]; mean [SD] age, 64.5 [7.9] years) were included. The knee osteoarthritis incident rate was 8.4% (793 of 9483 knees) for a mean (SD) follow-up time of 6.33 (2.46) years. Higher weight-bearing activity was associated with increased odds of incident knee osteoarthritis (odds ratio [OR], 1.22; 95% CI, 1.10-1.35; P < .001), but non-weight-bearing activity was not (OR, 1.04; 95% CI, 0.95-1.15; P = .37). In the analysis stratified by LMI tertiles, the association of weight-bearing activity with incident osteoarthritis was found only among 431 patients in the lowest LMI tertile (OR, 1.53; 95% CI, 1.15-2.04; P = .003), but not among patients in the middle or high LMI tertile. Conclusions and Relevance: The findings of this study suggest that weight-bearing activity is associated with incident knee osteoarthritis in people with low levels of lower-limb muscle mass, which might be a promising avenue for tailored advice for physical activity.

Exercise therapy for knee osteoarthritis pain: how does it work? A study protocol for a randomised controlled trial.

INTRODUCTION: Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on knee osteoarthritic (KOA) pain, but the mechanisms of action remain unclear. Both exercise-induced anti-inflammation and central sensitisation are promising pathways for pain relief in response to exercise therapy in patients with KOA: MST has the potential to decrease inflammation and BGA has the potential to decrease central sensitisation. Hence, this study aims to examine inflammation and central sensitisation as mediators for the effect of MST and/or BGA on pain in patients with KOA. METHODS AND ANALYSIS: The Knee OsteoArthritis PAIN trial started on 10 January 2020 (anticipated end: April 2024). The three-arm clinical trial aims to recruit 90 KOA patients who will be randomly allocated to 12 weeks of (1) MST, (2) BGA or (3) care as usual. Assessments will be performed at baseline, 13 and 52 weeks after finishing the intervention. Outcomes, including pain (Knee injury and Osteoarthritis Outcome Score), were chosen in line with the OARSI recommendations for clinical trials of rehabilitation interventions for OA and the IMMPACT/OMERACT recommendations for the assessment of physical function in chronic pain clinical trials. Inflammation as well as features of central sensitisation (including conditioned pain modulation, offset analgesia, temporal summation of pain and event-related potentials following electrical stimulation), will be considered as treatment mediators. A multiple mediators model will be estimated with a path-analysis using structural equation models. In July 2023, all 90 KOA patients have been included and 42 participants already finished the study. ETHICS AND DISSEMINATION: This study obtained ethics approval (B.U.N. 143201941843). Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists and clinicians. TRIAL REGISTRATION NUMBER: NCT04362618.

Content Validition and Psychometric Evaluation of the Self-efficacy and Performance in Self-management Support Instrument for Physiotherapists.

OBJECTIVE: To develop and psychometrically test the Self-Efficacy and Performance in Self-Management Support instrument for physiotherapists (SEPSS-PT), based on the SEPSS-36, the corresponding instrument for nurses. DESIGN: Instrument development including content validation and psychometric evaluation (construct validity, factor structure, and reliability). SETTING: Data were collected from literature, expertmeetings, and online questionnaire PARTICIPANTS: Next to a comprehensive literature study, experts (self-management experts (n=2); physiotherapists (n=10); patients (n=6)) and physiotherapists and physiotherapy students (n=334), participated in different stages of the study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. A literature study (n=42 reviews) and consultations with physiotherapists and patients identified the specific content for physiotherapy. The Five-A's model and overarching competencies of "supportive partnership attitude", were used to structure the items. Psychometric evaluation of the draft questionnaire (40 items) was tested in a sample of 334 physiotherapists and physiotherapy students from the Netherlands, of whom 33 filled out the questionnaire twice to establish the test-retest reliability. RESULTS: Confirmatory factor analyses revealed satisfactory fit indices for both the 6-factor model and hierarchical model, with best fit for the 6-factor model. The questionnaire discriminated between physiotherapists and physiotherapy students, and between physiotherapists who did or did not consider self-management support important. The overall internal consistency (Cronbach's alpha) was high, both for the self-efficacy and the performance items. In most of the subscales, test-retest intra-class correlation coefficients for both overall self-efficacy and performance were good, but in 3 subscales insufficient for performance. CONCLUSION: The SEPSS-PT questionnaire is a 40-item, Likert-scaled instrument with good content and construct validity, good internal consistency and reliability, and sufficient test-retest reliability. Future research in a larger and more diverse sample could confirm stability and discriminating power.

Factors associated with meniscus volume in knees free of degenerative features.

OBJECTIVES: To explore factors that were associated with meniscus volume in knees free of radiographic osteoarthritis (OA) features and symptoms of OA. METHODS: In the third Rotterdam Study cohort, clinical, radiographic, and magnetic resonance data were obtained at baseline (BL) and after 5 years of follow-up. Meniscus volumes and their change over time were calculated after semi-automatic segmentation on Magnetic Resonance Imaging. Knees with radiographic OA features (Kellgren and Lawrence>0) or clinical diagnosis of OA (American College of Rheumatology) at BL were excluded. Ten OA risk factors were adjusted in the multivariable analysis (generalized estimating equations), treating two knees within subjects as repeated measurements. RESULTS: From 1065 knees (570 subjects), the average (standard deviation) age and Body mass index (BMI) of included subjects were 54.3 (3.7) years and 26.5 (4.4) kg/m2. At BL, nine factors (varus alignment, higher BMI, meniscus pathologies, meniscus extrusion, cartilage lesions, injury, greater physical activity level, quadriceps muscle strength, and higher age) were significantly associated with greater meniscus volume. Five factors (injury, meniscus pathologies, meniscus extrusion, higher age, and change of BMI) were significantly associated with meniscus volume loss. CONCLUSIONS: Modifiable factors (varus alignment, BMI, physical activity level, and quadriceps muscle strength) and non-modifiable factors (higher age, injury, meniscus pathologies, meniscus extrusion, and cartilage lesions) were all associated with meniscus volume or meniscus volume loss over time.

Series: Public engagement with research. Part 4: Maximising the benefits of involving the public in research implementation.

This final article in the four-part series focuses on the often neglected yet important role of the public in implementing research in General Practice and Primary Care more broadly. Experience in implementation of findings from research with public engagement in Primary Care has highlighted how partnership working with patients and the public is important in transitioning from 'what we know' from the evidence-base to 'what we do' in practice. Factors related to Primary Care research that make public engagement important are highlighted e.g. implementing complex interventions, implementing interventions that increase health equity, implementing interventions in countries with different primary healthcare system strengths. Involvement of patients and public can enhance the development of modelling and simulation included in studies on systems modelling for improving health services. We draw on the emerging evidence base to describe public engagement in implementation and offer some guiding principles for engaging with the public in the implementation in General Practice and Primary Care in general. Illustrative case studies are included to support others wishing to offer meaningful engagement in implementing research evidence.

Implementing lifestyle-related treatment modalities in osteoarthritis care: Identification of implementation strategies using the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool.

AIMS: Despite recommendations in international clinical guidelines, lifestyle-related treatment modalities (LRTMs) are currently underutilised in the conservative treatment of patients with hip and/or knee osteoarthritis. This study aimed to identify implementation strategies in order to address barriers to implementing LRTMs from the perspective of healthcare professionals (HCPs). METHODS: The Consolidated Framework for Implementation Research (CFIR)-Expert Recommendations for Implementing Change (ERIC) Implementation Strategy Matching Tool was applied. First, previously identified influencing factors among primary and secondary HCPs were mapped onto the corresponding CFIR constructs/subconstructs by two researchers. Second, the CFIR-based barriers relevant for all HCPs were entered into the tool. Third, the CFIR-based barriers specific to one or more subgroups of HCPs served as additional input for the tool. Finally, a selection of ERIC implementation strategies was made based on the tool's output. RESULTS: Fourteen implementation strategies were selected. The strategy most endorsed by the tool was 'build a coalition'. Eight of the selected strategies belonged to the ERIC cluster 'develop stakeholder interrelationships'. Other strategies were part of the clusters 'use evaluative and iterative strategies' (n = 3), 'utilise financial strategies' (n = 2), and 'engage consumers' (n = 1). CONCLUSIONS: The findings emphasise the importance of an interdisciplinary approach when addressing the implementation of LRTMs in osteoarthritis care. The final selection of implementation strategies forms the basis for a tailored implementation plan. Future work should focus on further operationalising the implementation strategies and evaluating the effectiveness of the resulting implementation plan.

Nocturnal pain and fatigue in middle-aged persons with hip symptoms suspected to be osteoarthritis, is there a link in 10-year follow-up of the CHECK study?

Objective: To explore the prevalence of nocturnal pain and fatigue in participants with hip symptoms suspected to be early osteoarthritis (OA) and to test the mediating effect of nocturnal pain on the association between hip OA pain and fatigue. Methods: We included participants with hip pain but no knee pain at baseline, from the Cohort Hip and Cohort Knee (CHECK)-study. Severity of hip OA pain was determined using the Numeric-Rating-Scale-pain-score last week. Fatigue was assessed using the SF-36 Fatigue subscale. Nocturnal pain was determined using the WOMAC-question: "How much pain have you experienced in the last 48 â€‹h at night while in bed?". Hip OA pain, nocturnal pain and fatigue were measured repeatedly during 10-year follow-up. Path analysis were used per time point to determine the direct effect of OA pain on fatigue and the indirect effect through nocturnal pain. Results: In 170 participants (female: 76%; mean age: 55.7 years; mean BMI: 25.5 â€‹kg/m2) the prevalence of nocturnal pain varied between 22 and 35% and the prevalence of fatigue ranged between 14 and 18%. Hip OA pain was associated with nocturnal pain and fatigue. The direct effect of hip OA pain on fatigue was significant at all-time points. No significant mediating effect of nocturnal pain was found. Conclusion: In this cohort of participants suspected to have early hip OA, the prevalence of fatigue remained stable and the prevalence of nocturnal pain decreased slightly over 10-year follow-up. We did not find a mediating effect of nocturnal pain in the pathway between hip OA pain and fatigue.

Association between baseline meniscal extrusion and long-term incident knee osteoarthritis in two different cohorts.

OBJECTIVE: Previously, we identified a significant association between meniscal extrusion and short-term incident knee osteoarthritis (KOA). To validate these findings, we evaluated long-term incident KOA in knees with meniscus extrusion, using two different cohorts. METHODS: We used data from the PROOF study, which evaluated a high-risk population of overweight women, and a female subcohort of the population-based Rotterdam Study (RS). Meniscal extrusion was defined as ≥ 3 mm on MRI. Outcomes were incident radiographic (KL ≥ 2) or clinical KOA according to the ACR criteria, assessed at 6.6 years (PROOF) and 5.1 years (RS). With generalized estimating equations, we determined the association of knees with and without baseline meniscal extrusion and incident KOA, adjusting for confounders. Furthermore, we computed the population attributable risk percentage (PAR%) of meniscal extrusion. RESULTS: PROOF: of 421 available knees 23% had baseline meniscal extrusion. Incident radiographic KOA was significantly higher in knees with meniscal extrusion compared to those without (adjusted OR 2.54, 95% CI 1.34, 4.80; p = 0.004; PAR 21%). Incident clinical KOA was also significantly higher (adjusted OR 2.44, 95% CI 1.29, 4.60; p = 0.006; PAR 19%). RS: 46% of 872 available knees had meniscal extrusion. Incident radiographic KOA was significantly higher (adjusted OR 9.86, 95% CI 2.13, 45.67; p = 0.002; PAR 77%). Incident clinical KOA was borderline significantly higher (adjusted OR 2.65, 95% CI 0.96, 7.30; p = 0.06; PAR 44%). CONCLUSION: Meniscal extrusion is significantly associated with long-term incident KOA. A high number of incident cases were attributable to extrusion.

A systematic review of the sex differences in risk factors for knee osteoarthritis.

OBJECTIVES: Previous systematic reviews focused on the evidence of common risk factors for knee OA (KOA); however, the effect and strength of association between risk factors and KOA might be different between the two sexes. The aim of the present systematic review was to determine the current evidence on sex differences in the association between risk factors and KOA and their prevalence. METHODS: We searched the following electronic bibliographic databases: MEDLINE (PubMed), EMBASE and Web of Science. A methodological quality assessment was conducted independently by two researchers according to an adapted version of the standardized set of criteria known as the Newcastle-Ottawa Quality Assessment Scale (NOS). The NOS, a star system, was converted to three categories of quality. RESULTS: In total, 27 studies reported sex-specific risk estimates on several risk factors for KOA. Out of the 22 longitudinal cohort studies (except one nested case-control), 12 were of good quality and 10 were of fair quality. The five cross-sectional studies consisted of one of good, three of fair and one of poor quality. There was an indication of sex differences in risk factors leading to higher risk of KOA: high BMI, alcohol consumption, atherosclerosis and high vitamin E levels in women, and high physical activity, soft drink consumption and abdominal obesity in men. Knee injury, high blood pressure and low step rate seem to affect both women and men. CONCLUSION: More good quality studies are needed to assess sex differences in risk factors for KOA, especially for symptomatic/clinical OA.

Nocturnal pain, is the pain different compared with pain during the day? An exploratory cross-sectional study in patients with hip and knee osteoarthritis.

OBJECTIVE: To explore characteristics of nocturnal pain and to identify differences in participants' characteristics and osteoarthritis (OA) symptoms between hip and knee OA participants with and without nocturnal pain. METHODS: Data for this exploratory cross-sectional study were obtained from an online survey, distributed through social media and patient associations in the period from April 2020 until May 2020, which was conducted in 101 participants with (self-reported) hip or knee OA. Descriptive statistics were used to provide insight into the characteristics of the study population. Pain intensity, localization, dimension, and impact of (nocturnal) pain on sleep were described and compared with daytime pain. RESULTS: Nocturnal pain was reported by 76/101 (75%) participants. Participants with nocturnal pain scored higher visual analogue scale (VAS) scores for their nocturnal pain compared with their pain at the moment (respectively: median VAS score 49.5 vs. 40.0). Their day pain rating indexes of sensory-discriminative dimension were higher compared with their nocturnal pain. Comparison between participants with and without nocturnal pain showed that participants with nocturnal pain were affected by intermittent, constant, and radiating pain. Pain had more impact on their sleep and they scored their pain at its worst higher compared with participants without nocturnal pain. CONCLUSION: In participants with nocturnal pain (75%), we found that their VAS pain scores were not in harmony with their pain expressed in words. This study increases awareness of nocturnal pain in OA patients in general practice. More research is needed to provide general practitioners possible interventions for patients with OA and nocturnal pain.

Nocturnal pain is an important part of the pain experience in osteoarthritis (OA) and highlighted as key concern by patients with hip and knee OA. Reports have shown a wide range in prevalence of nocturnal hip and knee pain in OA patients (14%­85%). We found that participants with nocturnal pain (76/101 = 75%) were more often affected by both intermittent and constant pain, reported higher pain scores for pain at its worst and pain had more impact on their sleep compared with those without nocturnal pain. Participants with nocturnal pain scored higher visual analogue scale (VAS) scores for their nocturnal pain compared with their pain at the moment. On the other hand, they scored the pain expressed in words higher for their day pain than for their nocturnal pain. More research is needed to explore factors that associate with nocturnal pain and to explore how healthcare professionals can support people with nocturnal pain.

Plasma proteomics identifies CRTAC1 as a biomarker for osteoarthritis severity and progression.

OBJECTIVES: The aim of this study was to identify biomarkers for radiographic OA severity and progression acting within the inflammation and metabolic pathways. METHODS: For 3517 Rotterdam Study participants, 184 plasma protein levels were measured using Olink inflammation and cardiometabolic panels. We studied associations with severity and progression of knee, hip and hand OA and a composite overall OA burden score by multivariable regression models, adjusting for age, sex, cell counts and BMI. RESULTS: We found 18 significantly associated proteins for overall OA burden, of which 5 stayed significant after multiple testing correction: circulating cartilage acidic protein 1 (CRTAC1), cartilage oligomeric matrix protein (COMP), thrombospondin 4, IL-18 receptor 1 (IL-18R1) and TNF ligand superfamily member 14. These proteins were also associated with progression of knee OA, with the exception of IL-18R1. The strongest association was found for the level of CRTAC1, with 1 s.d. increase in protein level resulting in an increase of 0.09 (95% CI 0.06, 0.12) in the overall OA Kellgren-Lawrence sum score (P = 2.9 × 10-8) in the model adjusted for age, sex, BMI and cell counts. This association was also present with the severity of OA in all three joints and progression of knee OA and was independent of BMI. We observed a stronger association for CRTAC1 with OA than for the well-known OA biomarker COMP. CONCLUSION: We identified several compelling biomarkers reflecting the overall OA burden and the increased risk for OA progression. CRTAC1 was the most compelling and robust biomarker for OA severity and progression. Such a biomarker may be used for disease monitoring.

Accelerated menopausal changes as human disease model 'FOCUM' for the development of osteoarthritis and other degenerative disorders: protocol for a prospective cohort study.

INTRODUCTION: The incidence of degenerative disorders, including osteoarthritis (OA), increases rapidly in women after menopause. However, the influence of the menopause is still insufficiently investigated due to the slowness of menopausal transition. In this study, a novel human model is used in which it is expected that menopausal-related changes will occur faster. This is the Females discontinuing Oral Contraceptives Use at Menopausal age model. The ultimate aim is to link these changes to OA and other degenerative disorders, including cardiovascular diseases, diabetes, osteoporosis and tendinopathies. METHODS AND ANALYSIS: This is a pilot observational prospective cohort study with 2 years of follow-up. Fifty women aged 50-60 who use oral contraceptive (OC) and have the intention to stop are included. Measurements are performed once before stopping OC, and four times thereafter at 6 weeks, 6 months, 1 year and 2 years. At every time point, a questionnaire is filled in and a sample of blood is drawn. At the first and final time points, a physical examination, hand radiographs and a MRI scan of one knee are performed. The primary OA outcome is progression of the MRI Osteoarthritis Knee Score. Secondary OA outcomes are the development of clinical knee and hand OA, development of knee OA according to the MRI definition, and progression of radiographic features for hand OA. Principal component analysis will be used to assess which changes occur after stopping OC. Univariate and multivariate generalised estimating equation models will be used to test for associations between these components and OA. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of the Erasmus MC University Medical Center Rotterdam (MEC-2019-0592). All participants must give informed consent before data collection. Results will be disseminated in national and international journals. TRIAL REGISTRATION NUMBER: NL70796.078.19.

Course of pain and fluctuations in pain related to suspected early hip osteoarthritis: the CHECK study.

OBJECTIVES: To evaluate the prevalence during a 10-year follow-up of clinically relevant fluctuations in pain and the course of hip pain in participants with hip complaints suspected to be early stage hip osteoarthritis (OA). To distinguish between participants with relevant fluctuations in pain and those without based on baseline characteristics. METHODS: Data were collected at baseline and after 2, 5, 8, and 10 years on 495 participants from the Cohort Hip and Cohort Knee Study (CHECK) with hip pain at baseline. Baseline demographic, anamnestic, and physical-examination characteristics were assessed. The primary outcome was levels of pain in the past week (scored using 0-10 Numeric Rating Scale) at follow-up assessments. Relevant fluctuation was defined as average absolute residuals greater than 1 after fitting a straight line to the participant's pain scores over time. RESULTS: The majority of the participants (76%) had stable or decreasing pain. Relevant fluctuations were found in 37% of the participants. The following baseline variables were positively associated with the presence of relevant fluctuations: higher levels of pain in the past week, use of pain transformation as a coping style, higher number of comorbidities, use of pain medication, and higher levels of high-sensitivity C-reactive protein. No associations were found for baseline radiographic hip OA or clinical hip OA. CONCLUSION: During a 10-year follow-up, the majority of participants had stable or decreasing pain levels. In those participants with relevant fluctuation (37%), a limited number of baseline variables were associated with increased odds of having relevant fluctuations in pain.

Pain appears to be an important reason for consulting the general practitioner (GP) for hip osteoarthritis (OA) complaints. We know that hip pain remained quite stable over 10 years. Also is known that there is considerable variety between patients in pain. In this study, we found relevant pain fluctuations in 37% of primary care patients with hip complaints over a period of 10 years. The pain fluctuation was not associated with having osteoarthritis, neither radiographic hip OA (diagnosed based on a X-ray) or clinical hip OA (determined according to the American College of Rheumatology (ACR) criteria) at baseline. More research is needed to discover why some people experience fluctuations in time than others.

Best Evidence Osteoarthritis Care: What Are the Recommendations and What Is Needed to Improve Practice?

This article provides an overview of osteoarthritis (OA) management recommendations and strategies to improve clinical practice concordance with clinical guidelines. In many countries, the primary point of care for a person with OA is typically general practitioners and physiotherapists. Optimal primary care focuses on core OA treatments, namely education for self-management and lifestyle interventions encompassing increased physical activity, therapeutic exercise, and weight loss (if indicated). Quality indicators are used in clinical practice and research to determine the quality of care and in some settings, are used as knowledge translation tools to address existing evidence-to-practice gaps.

Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial.

INTRODUCTION: Obesity is the most important modifiable risk factor for knee osteoarthritis (KOA). Especially in an early stage of the disease, weight loss is important to prevent further clinical and structural progression. Since 2019, general practitioners (GPs) in the Netherlands can refer eligible patients to a combined lifestyle intervention (GLI) to promote physical activity, healthy nutrition and behavioural change. However, GPs scarcely refer patients with KOA to the GLI potentially due to a lack of evidence about the (cost-)effectiveness. The aim of this study is to determine the (cost-)effectiveness of the GLI for patients with early-stage KOA in primary care. METHODS AND ANALYSIS: For this pragmatic, multi-centre randomised controlled trial, 234 participants (aged 45-70 years) with National Institute for Health and Care Excellence (NICE) guideline diagnosis of clinical KOA and a body mass index above 25 kg/m2 will be recruited using a range of online and offline strategies and from general practices in the Netherlands. Participants will receive nine 3-monthly questionnaires. In addition, participants will be invited for a physical examination, MRI assessment and blood collection at baseline and at 24-month follow-up. After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only. Primary outcomes are self-reported knee pain over 24 months, structural progression on MRI at 24 months, weight loss at 24 months, as well as societal costs and Quality-Adjusted Life-Years over 24-month follow-up. Analyses will be performed following the intention-to-treat principle using linear mixed-effects regression models. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Medical Ethical Committee of the Erasmus MC University Medical Center Rotterdam, The Netherlands (MEC-2020-0943). All participants will provide written informed consent. The results will be disseminated through publications in peer-reviewed journals, presentations at international conferences and among study participants and healthcare professionals. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NL9355).

No Added Value of Duloxetine in Patients With Chronic Pain due to Hip or Knee Osteoarthritis: A Cluster-Randomized Trial.

OBJECTIVE: To assess the effectiveness of duloxetine in addition to usual care in patients with chronic osteoarthritis (OA) pain. The cost-effectiveness and whether the presence of symptoms of centralized pain alters the response to duloxetine were secondary objectives. METHODS: We conducted an open-label, cluster-randomized trial. Patients with chronic hip or knee OA pain who had an insufficient response to acetaminophen and nonsteroidal antiinflammatory drugs were included. Randomization took place at the general practice level, and patients received duloxetine (60 mg/day) in addition to usual care or usual care alone. The presence of centralized pain was defined as a modified PainDETECT Questionnaire score >12. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores (scale 0-20) at 3 months after the initiation of treatment. Our aim was to detect a difference between the groups of a clinically relevant effect of 1.9 points (effect size 0.4). We used a linear mixed model with repeated measurements to analyze the data. RESULTS: In total, 133 patients were included, and 132 patients were randomized into treatment groups. A total of 66 patients (at 31 practices) were randomized to receive duloxetine in addition to usual care, and 66 patients (at 35 practices) were randomized to receive usual care alone. We found no differences in WOMAC pain scores between the groups at 3 months (adjusted difference -0.58 [95% confidence interval (95% CI) -1.80, 0.63]) or at 12 months (adjusted difference -0.26 [95% CI -1.86, 1.34]). In the subgroup of patients with centralized pain symptoms, we also found no effect of duloxetine compared to usual care alone (adjusted difference -0.32 [95% CI -2.32, 1.67]). CONCLUSION: We found no effect of duloxetine added to usual care compared to usual care alone in patients with chronic knee or hip OA pain. Another trial including patients with centralized pain symptoms should be conducted to validate our results.

Incidence and Prevalence of Knee Osteoarthritis Using Codified and Narrative Data From Electronic Health Records: A Population-Based Study.

OBJECTIVE: To determine the incidence and prevalence of knee osteoarthritis (OA) using codified and narrative data from general practices throughout The Netherlands. METHODS: This retrospective cohort study was conducted using the Integrated Primary Care Information database. Patients with codified knee OA were selected, and an algorithm was developed to identify patients with narratively diagnosed knee OA only. Point prevalence proportions and incidence rates among people age ≥30 years were assessed from 2008 to 2019. The association of comorbidities with codified knee OA was analyzed using multivariable logistic regression. RESULTS: The positive predicted value of narratively diagnosed knee OA only was 94.0% (95% confidence interval [95% CI] 87.4-100%) and for codified knee OA 96.0% (95% CI 90.6-100%). Including narrative data in addition to codified data resulted in a prevalence 1.83-2.01 times higher (over the study years); prevalence increased from 5.8% to 11.8% between 2008 and 2019. The incidence rate was 1.93-2.28 times higher and increased from 9.98 per 1,000 person-years to 13.8 per 1,000 person-years between 2008 and 2019. Among patients with codified knee OA, 39.4% were previously diagnosed narratively with knee OA, on average ~3 years earlier. Comorbidities influenced the likelihood of being recorded with codified knee OA. CONCLUSION: Our study of a Dutch primary care database showed that current incidence and prevalence estimates based on codified data alone from electronic health records are underestimated. Narrative data can be incorporated in addition to codified data to identify knee OA patients more accurately.

The use and safety of corticosteroid injections for shoulder pain in general practice: a retrospective cohort study.

BACKGROUND: Guidelines for shoulder pain in general practice recommend treatment with corticosteroid injections (CSI) if initial pain management fails. However, little is known about the actual use and safety of CSIs in treatment by general practitioners (GP). OBJECTIVE: The objective of this study was to gain insight into the use and safety of CSIs for patients with a new episode of shoulder pain in general practice. METHODS: A retrospective cohort study was conducted using a healthcare database containing the electronic medical records of approximately 200,000 patients in general practice. A search algorithm was constructed to identify patients with a new episode of shoulder pain between January 2012 and December 2017. Data on the use of CSIs in 2 random samples (n = 1,000) were manually validated for a 12-month period after the diagnosis. RESULTS: In total, 26% of the patients with a new episode of shoulder pain received a CSI. The patient's age (OR 1.03, 95% CI 1.02-1.04) and a history of shoulder pain (OR 1.52, 95% CI 1.13-2.12) were significantly associated with the administration of a CSI. Half of the patients received the CSI in the first consultation. The patient's age was positively associated with the likelihood of receiving the CSI in the first consultation (OR 1.01, 95% CI 1.00-1.02). No serious adverse reactions were recorded by the GP. CONCLUSION: In contrast to the guidelines, CSIs were frequently administered in the first consultation. Older patients and patients with a history of shoulder pain were more likely to receive a CSI for shoulder pain.