ABSTRACT
Background: The high incidence of knee injuries in football/handball challenges effective prevention. Identifying tangible and modifiable factors associated with a knee injury may innovate preventive actions. Engaging key stakeholders can reveal crucial insights that could improve knee injury prevention in football/handball. Objective: To investigate football/handball stakeholders' perspectives on reasons for acute and severe knee injuries to generate a conceptual model on important factors associated with knee injuries in football/handball. Methods: Mixed-method participatory Group Concept Mapping was applied to collect statements from football/handball stakeholders (players/coaches/healthcare staff/researchers) on the question, 'What may explain why some players sustain a knee injury?'. Participants rated the importance and feasibility of screening for each statement. Multidimensional scaling and hierarchical cluster analysis produced a cluster map, forming the basis for developing a final conceptual model. Results: Stakeholders (n=37) generated and sorted 100 statements. Cluster analysis followed by cluster map validation yielded seven themes: (1) the player's physical and motor skill profile, (2) preparation and training, (3) footwear and playing surface, (4) the sport's impact on the risk of injury, (5) mental and physical fatigue, (6) history of injury and 7) genetics and context. A final conceptual model illustrating factors associated with knee injuries in football/handball was developed. Forty-six statements were identified as both important and feasible to screen for. Conclusions: Stakeholders' perspectives on knee injuries in football/handball revealed a complex interplay of factors. We developed a conceptual model fostering stakeholder dialogue for enhanced prevention. Key among its themes is 'preparation and training'.
ABSTRACT
PURPOSE: Estimating loading of the knee joint may be helpful in managing degenerative joint diseases. Contemporary methods to estimate loading involve calculating knee joint contact forces using musculoskeletal modeling and simulation from motion capture (MOCAP) data, which must be collected in a specialized environment and analyzed by a trained expert. To make the estimation of knee joint loading more accessible, simple input predictors should be used for predicting knee joint loading using artificial neural networks. METHODS: We trained feedforward artificial neural networks (ANNs) to predict knee joint loading peaks from the mass, height, age, sex, walking speed, and knee flexion angle (KFA) of subjects using their existing MOCAP data. We also collected an independent MOCAP dataset while recording walking with a video camera (VC) and inertial measurement units (IMUs). We quantified the prediction accuracy of the ANNs using walking speed and KFA estimates from (1) MOCAP data, (2) VC data, and (3) IMU data separately (i.e., we quantified three sets of prediction accuracy metrics). RESULTS: Using portable modalities, we achieved prediction accuracies between 0.13 and 0.37 root mean square error normalized to the mean of the musculoskeletal analysis-based reference values. The correlation between the predicted and reference loading peaks varied between 0.65 and 0.91. This was comparable to the prediction accuracies obtained when obtaining predictors from motion capture data. DISCUSSION: The prediction results show that both VCs and IMUs can be used to estimate predictors that can be used in estimating knee joint loading outside the motion laboratory. Future studies should investigate the usability of the methods in an out-of-laboratory setting.
ABSTRACT
Obesity is a known risk factor for development of osteoarthritis (OA). Numerical tools like finite-element (FE) models combined with degenerative algorithms have been developed to understand the interplay between OA and obesity. In this study, we aimed to predict knee cartilage degeneration in a cohort of obese adults to investigate the importance of patient-specific information on degeneration predictions. We used a validated FE modeling approach and three different age-dependent functions (step-wise, exponential, and linear) to simulate cartilage degradation under overloading in the knee joint. Gait motion analysis and magnetic resonance imaging data from 115 obese individuals with knee OA were used for musculoskeletal and FE modeling. Cartilage degeneration predictions were contrasted with Kellgren-Lawrence (KL) and Boston-Leeds Osteoarthritis Knee Score (BLOKS) grades. The findings show that overall, the similarities between numerical predictions and clinical measures were better for the medial (average area under the curve (AUC) = 0.62) compared to the lateral compartment (average AUC = 0.52) of the knee. Classification results for KL grades, full patient-specific models and patient-specific geometry with generic gait data showed higher AUC values (AUC = 0.71 and AUC = 0.68, respectively) compared to generic geometry and patient-specific gait (AUC = 0.48). For BLOKS grades, AUC values for both full patient-specific models and for patient-specific geometry with generic gait locomotion were higher (AUC = 0.66 and AUC = 0.64, respectively) compared to when the generic geometry and patient-specific gait were used (AUC = 0.53). In summary, our study highlights the importance of considering individual information in knee OA prediction. Nevertheless, our findings suggest that personalized gait play a smaller role in the OA prediction and classification capacity than personalized joint geometry.
ABSTRACT
OBJECTIVE: To compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. METHOD: This was a randomised single-blind trial. Patients were randomised to two matched conversations. An IP conversation concerning the participant's knee pain-related illness perception (IP) or an RPC concerning the participant's motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm visual analogue scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. RESULTS: 103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, -13.7 (standard error [SE]: 3.2) in the IPC group and -13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of -0.7 (95% CI: -8.3 to 6.9; P = 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. CONCLUSION: A conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection when compared to a similar control conversation concerning motivations for participating in research. TRIAL REGISTRATION: NCT05225480.
ABSTRACT
Background: Stroke frequently leads to hospital admission and subsequent rehabilitation in order to overcome poststroke sequelae, such as motor impairments. Efficient planning of the steps following hospital admission includes early prediction of whether the patient can be discharged home or not. Early assessment of motor performance in patients with stroke-induced motor deficits may be able to function as a predictor of discharge destination but is less explored. Objective: The primary objective was to assess the predictive validity of the Motor Assessment Scale (MAS) on discharge destination both regarding total score and regarding subscores (transfer-mobility items and upper extremity items). Design: The study was designed as a prospective cohort study. Subjects: Thirty-seven consecutively recruited patients with stroke are the subjects of the study. Methods: Logistic regression model was used to calculate the odds of being discharged to own home upon hospital admittance. The predictive ability was examined with a receiving operator characteristic (ROC) curve, and cut-points from the curve were employed in Cox regression. Results: A one-unit higher score on the total MAS significantly increased the odds of being discharged home upon hospital admittance (odds ratio (OR) 1.14, 95% CI 1.04-1.25). The same pattern was observed with the summed items of 1-5 and 6-8. The total MAS showed sensitivity of 91.7% and specificity of 68.0%. Patients having a total MAS score ≥ 24 were 17 times more likely to be discharged home (HR 17.64, 95% CI 2.23-139.57) compared to patients with a lower score. Conclusion: Motor function measured by the MAS can be applied as a predictor of discharge destination upon hospital admission after stroke in Danish setting.
ABSTRACT
OBJECTIVE: Can physical therapists who are treating patients with patellofemoral pain (PFP) predict the outcome of a 12-week exercise intervention based on initial assessment, and what are the physical therapists' reasons for prediction? DESIGN: Secondary analysis of a randomized trial. METHODS: After the initial assessment, physical therapists were asked to predict the prognosis of 200 patients with PFP who were allocated to 12 weeks of quadriceps exercises (QEs) or hip exercises (HEs) on a 1-to-10 Likert scale, and to describe their reasoning for the prediction score. OUTCOMES: measures were changes from baseline to weeks 12 and 26 on the Anterior Knee Pain Scale (range 0-100) and a transition questionnaire (TransQ). Linear mixed-effects models were used to assess the prediction. Secondly, we used a qualitative approach to summarize the physical therapists' reasoning (written notes) when predicting the outcome. RESULTS: There was no association between physical therapists' prognosis and changes in Anterior Knee Pain Scale for QE or HE at weeks 12 and 26 (slopes: -0.14 to -0.51 with wide 95% confidence intervals). There was no association between physical therapists' assessment of prognosis using TransQ for QE or HE at weeks 12 and 26 (odds ratio: 0.99 to 1.17 with wide 95% confidence intervals). CONCLUSION: Physical therapists' prognosis based on initial assessment was not associated with outcomes after 12 weeks of either quadriceps or hip exercise therapy among patients with PFP. Physical therapists' prognoses were not useful as a source of information and to identify PFP patients with poor or good projected outcomes. J Orthop Sports Phys Ther 2024;54(8):541-550. Epub 6 June 2024. doi:10.2519/jospt.2024.12258.
Subject(s)
Exercise Therapy , Patellofemoral Pain Syndrome , Physical Therapists , Quadriceps Muscle , Humans , Patellofemoral Pain Syndrome/therapy , Patellofemoral Pain Syndrome/physiopathology , Patellofemoral Pain Syndrome/rehabilitation , Exercise Therapy/methods , Prognosis , Female , Male , Adult , Quadriceps Muscle/physiopathology , Quadriceps Muscle/physiology , Pain Measurement , Young Adult , Treatment Outcome , Hip/physiopathologyABSTRACT
OBJECTIVE: There are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data. METHODS: This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0-100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs). RESULTS: 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (- 17.7 points (95% CI - 23.1; - 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI - 17.0; - 4.9), physical function (18.0 points; 95% CI - 19.1; - 10.6), and PGA (16.3 points; 95% CI - 23.1; - 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related. CONCLUSION: This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection. TRIAL REGISTRATION: Clinicaltrials.gov NCT04179552.
Subject(s)
Acrylic Resins , Osteoarthritis, Knee , Humans , Female , Osteoarthritis, Knee/drug therapy , Acrylic Resins/administration & dosage , Male , Aged , Middle Aged , Treatment Outcome , Follow-Up Studies , Injections, Intra-Articular , Time Factors , Hydrogels/administration & dosage , Aged, 80 and overABSTRACT
OBJECTIVE: To examine the pain relief effects of comparators (placebos and untreated control groups) in hand osteoarthritis trials and the impact of contextual factors. METHODS: We systematically searched PubMed, EMBASE and CENTRAL from inception to December 26, 2021. We included randomised controlled trials of people with hand osteoarthritis with a placebo or an untreated control group. We assessed the Risk of Bias with Cochrane Risk-of-Bias tool version 2. Each comparator was contrasted with a null-arm, imputed as having a zero change from baseline with the same standard deviation as the comparator. We combined the standardised mean differences with a random effects meta-analysis. The contextual factors' effect was explored in meta-regression and stratified models with pain as the dependent variable. RESULTS: 84 trials (7262 participants) were eligible for quantitative synthesis, of which 76 (6462 participants) were eligible for the stratified analyses. Placebos were superior to their matched null-arms in relieving pain with an effect size of -0.51 (95% confidence interval -0.61 to -0.42), while untreated control groups were not. When analysing all comparators, blinded trial designs and low risk of bias were associated with higher pain relief compared to an open-label trial design and some concern or high risk of bias. CONCLUSION: The placebo response on pain for people with hand osteoarthritis was increased by appropriate blinding and a lower risk of bias assessment. Placebos were superior to a null-arm, while untreated control groups were not. Results emphasise the importance of using appropriate comparators in clinical trials. PROSPERO REGISTRATION ID: CRD42022298984.
Subject(s)
Hand Joints , Osteoarthritis , Randomized Controlled Trials as Topic , Humans , Control Groups , Hand Joints/physiopathology , Osteoarthritis/drug therapy , Placebos/therapeutic useABSTRACT
OBJECTIVES: To examine the effect of an early postsurgical intervention consisting of graded activity and pain education (GAPE) in patients with chronic low back pain (CLBP) undergoing lumbar spinal fusion (LSF) on sedentary behavior, disability, pain, fear of movement, self-efficacy for exercise and health-related quality of life (HRQoL) at 3-, 6-, and 12 months follow-up. DESIGN: A parallel-group, observer-blinded randomized controlled trial. SETTING: Department of Occupational- and Physiotherapy and the Centre for Rheumatology and Spine Diseases, Rigshospitalet, Denmark. PARTICIPANTS: In total, 144 participants undergoing an LSF for CLBP were randomly assigned to an intervention or a control group. INTERVENTIONS: The intervention group received 9 sessions of GAPE, based on principles of operant conditioning. MAIN OUTCOME MEASURES: The primary outcome was reduction in time spent in sedentary behavior, measured by an accelerometer at 3 months. The secondary outcomes were reduction in time spent in sedentary behavior at 12 months and changes from baseline to 3-, 6-, and 12 months on disability, pain, fear of movement, self-efficacy for exercise, and HRQoL. RESULTS: No difference in changes in sedentary behavior between groups was found 3 months after surgery. At 12 months after surgery, there was a significant difference between groups (mean difference: -25.4 min/d (95% confidence interval -49.1 to -1.7)) in favor of the intervention group. CONCLUSIONS: Compared with usual care, GAPE had no effect on short-term changes in sedentary behavior but GAPE had a statistical, but possibly not clinical significant effect on sedentary behavior 12 months after LSF. Further, the behavioral intervention was safe to perform.
Subject(s)
Fear , Low Back Pain , Lumbar Vertebrae , Quality of Life , Sedentary Behavior , Self Efficacy , Spinal Fusion , Humans , Male , Female , Middle Aged , Low Back Pain/rehabilitation , Lumbar Vertebrae/surgery , Patient Education as Topic/methods , Adult , Disability Evaluation , Single-Blind Method , Exercise Therapy/methods , Chronic Pain/rehabilitationABSTRACT
OBJECTIVES: To assess non-inferiority of intra-articular injectable polyacrylamide hydrogel (iPAAG) to hyaluronic acid (HA) on symptomatic benefit in individuals with knee osteoarthritis (OA). METHODS: This randomised, controlled, multi-centre trial recruited adults with symptomatic and radiographic knee OA from 3 clinical rheumatology sites in Denmark; two private clinics and one public hospital department. Participants were randomised 1:1 to receive a single intra-articular 6 mL injection of either HA or iPAAG on an outpatient basis. Primary outcome was change from baseline in WOMAC pain subscale after 26 weeks. Secondary outcomes were changes from baseline in WOMAC stiffness and physical function subscales, patients' global assessment of disease impact, EuroQoL-5D-5L, and proportion of positive OMERACT-OARSI responders after 26 and 52 weeks. RESULTS: 239 adults were randomised: 120 to HA and 119 to iPAAG. For the primary outcome, the least squares mean changes in WOMAC pain were -14.8 (95% CI: -18.0 to -11.7) for HA and -18.5 (95% CI: -21.7 to -15.4) for iPAAG; group difference: 3.7 (95% CI: -0.7 to 8.1). The lower boundary of the 95% CI respected the pre-specified non-inferiority margin of 9 WOMAC pain points. No statistically significant differences were observed for the secondary outcomes. For HA, 9 participants (7.6%) reported 13 adverse device effects (ADEs). For iPAAG, 35 participants (28.9%) reported 41 ADEs. All ADEs were mild/moderate, with no serious ADEs reported. CONCLUSIONS: iPAAG was found to be as effective and safe as HA for treatment of knee OA symptoms for at least 1 year after a single injection.
Subject(s)
Osteoarthritis , Practice Guidelines as Topic , Humans , Osteoarthritis/diagnosis , Osteoarthritis/therapy , EuropeABSTRACT
Exercise is universally recommended as a primary strategy for the management of knee osteoarthritis (OA) pain. The recommendations are based on results from more than 100 randomized controlled trials (RCTs) that compare exercise to no-attention control groups. However, due to the inherent difficulties with adequate placebo control, participant blinding and the use of patient-reported outcomes, the existing RCT evidence is imperfect. To better understand the evidence used to support a causal relationship between exercise and knee OA pain relief, we examined the existing evidence through the Bradford Hill considerations for causation. The Bradford Hill considerations, first proposed in 1965 by Sir Austin Bradford Hill, provide a framework for assessment of possible causal relationships. There are 9 considerations by which the evidence is reviewed: Strength of association, Consistency, Specificity, Temporality, Biological Gradient (Dose-Response), Plausibility, Coherence, Experiment, and Analogy. Viewing the evidence from these 9 viewpoints did neither bring forward indisputable evidence for nor against the causal relationship between exercise and improved knee OA pain. Rather, we conclude that the current evidence is not sufficient to support claims about (lack of) causality. With our review, we hope to advance the continued global conversation about how to improve the evidence-based management of patients with knee OA.
Subject(s)
Exercise Therapy , Osteoarthritis, Knee , Humans , Osteoarthritis, Knee/therapy , Exercise Therapy/methods , Arthralgia/etiology , Pain Management/methods , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE: Despite scarce evidence, guidelines recommend weight loss as a management strategy for patients with gout. We investigated the effect of an intensive dietary intervention on body weight and clinical measures of gout severity in individuals with obesity and gout. METHODS: We conducted a 16-week randomized nonmasked parallel-group trial in Denmark, randomly assigning (one-to-one) individuals with obesity and gout to a low-energy diet or a control diet. The primary outcome was change in body weight. Key secondary outcomes were changes in serum urate (SU) level and visual analog scale-assessed pain and fatigue. RESULTS: Between December 1, 2018, and June 1, 2019, 61 participants were included in the intention-to-treat population and randomly assigned to the intensive diet group (n = 29) or control diet group (n = 32). Participants had a mean age of 60.3 (SD 9.9) years and mean body mass index of 35.6 (SD 5.0), and 59 (97%) were men. After 16 weeks, there was a significant difference in change in body weight between the diet and control groups (-15.4 vs -7.7 kg; difference -7.7 kg [95% confidence interval -10.7 to -4.7], P < 0.001). Despite results being potentially in favor of a low-energy diet, we could not confirm differences in SU level changes and fatigue between groups. No differences in pain and gout flares were observed between groups. No serious adverse events or deaths occurred during the trial. CONCLUSION: An intensive dietary intervention was safe and effectively lowered body weight in people with obesity and gout, but the weight loss did not directly translate into effects on SU level, fatigue, and pain.
Subject(s)
Gout , Obesity , Proof of Concept Study , Weight Loss , Aged , Female , Humans , Male , Middle Aged , Body Mass Index , Diet, Reducing , Fatigue/etiology , Gout/complications , Gout/diet therapy , Obesity/complications , Uric Acid/bloodABSTRACT
Fibril-reinforced poroviscoelastic material models are considered state-of-the-art in modeling articular cartilage biomechanics. Yet, cartilage material parameters are often based on bovine tissue properties in computational knee joint models, although bovine properties are distinctly different from those of humans. Thus, we aimed to investigate how cartilage mechanical responses are affected in the knee joint model during walking when fibril-reinforced poroviscoelastic properties of cartilage are based on human data instead of bovine. We constructed a finite element knee joint model in which tibial and femoral cartilages were modeled as fibril-reinforced poroviscoelastic material using either human or bovine data. Joint loading was based on subject-specific gait data. The resulting mechanical responses of knee cartilage were compared between the knee joint models with human or bovine fibril-reinforced poroviscoelastic cartilage properties. Furthermore, we conducted a sensitivity analysis to determine which fibril-reinforced poroviscoelastic material parameters have the greatest impact on cartilage mechanical responses in the knee joint during walking. In general, bovine cartilage properties yielded greater maximum principal stresses and fluid pressures (both up to 30%) when compared to the human cartilage properties during the loading response in both femoral and tibial cartilage sites. Cartilage mechanical responses were very sensitive to the collagen fibril-related material parameter variations during walking while they were unresponsive to proteoglycan matrix or fluid flow-related material parameter variations. Taken together, human cartilage material properties should be accounted for when the goal is to compare absolute mechanical responses of knee joint cartilage as bovine material parameters lead to substantially different cartilage mechanical responses.
ABSTRACT
OBJECTIVE: To compare illness perception (IP), pain, functional level and health-related quality of life (HR-QoL) between patients with musculoskeletal pain who participate versus those who do not participate in clinical research projects. METHODS: Data were collected between 1 January 2019 and 31 December 2021 in patients visiting the Outpatient Osteoarthritis Clinic at Frederiksberg Hospital, Copenhagen, as part of either clinical research or regular treatment. Questionnaires were collected at baseline and after 10-18 months. Major outcome measure was the change from baseline to follow-up in the Brief Pain Inventory - Short Form (BPI-SF) item 'Average pain'. Secondary outcome measures included The Brief Illness Perception Questionnaire (B-IPQ), measured only at baseline, the EuroQol (EQ-5D-3L), the Health Assessment Questionnaire Disability Index and PainDETECT. RESULTS: 1495 patients were included with 358 (24%) categorised as research participants (exposed) and 1137 (76%) being non-participants (unexposed). The baseline B-IPQ item scores were generally more favourable in the exposed group with statistically significant standardised differences (SD) of 0.2-0.3. Similarly, an SD of 0.3 on the EQ-5D-3L score indicated a better HR-QoL in the exposed group. At follow-up, 24% in the exposed group and 27% in the unexposed group, completed the questionnaires. The mean BPI-sf Average pain between-group difference was: -0.01 points (95% CI: -0.6 to 0.6). Similar clinically irrelevant differences were seen in the other outcomes. CONCLUSIONS: Among musculoskeletal pain patients, research participants report more positive IP and better HR-QoL than non-participants. No additional effect of research participation was found in any outcome over time. TRIAL REGISTRATION NUMBER: NCT03785561.
Subject(s)
Musculoskeletal Pain , Quality of Life , Humans , Prospective Studies , Musculoskeletal Pain/etiology , Musculoskeletal Pain/therapy , Surveys and Questionnaires , Outcome Assessment, Health CareABSTRACT
Objective: To investigate the prognostic value of illness perception (IP) on knee pain, quality of life (QoL) and functional level in elderly individuals reporting knee pain. Design: A prospective cohort study of 1552 elderly with knee pain comparing two previously established clusters based on the Brief Illness Perception questionnaire. Cluster 1 ("Concerned optimists" [hypothesized unfavorable profile]; n â= â642) perceived their knee pain as a greater threat to them than Cluster 2 ("Unconcerned confident" [hypothesized favorable profile]; n â= â910). Primary outcome was the change from baseline to year 2 in the KOOS Pain subscale. Secondary outcomes were changes from baseline in quality of life (EuroQol-5 Domain and EQ VAS) and in the KOOS subscales Symptom, Activities of Daily Living, Knee-related QoL and Sports and recreation. Analyses were done on the original Intention-To-Survey (ITS) population, using repeated measures mixed linear models. Results: Among the ITS population, 841 (54%) responded to the 2-year survey. There was a statistically significant but clinically irrelevant cluster difference in the 2-year change from baseline in KOOS pain (mean difference: 6.0 KOOS points [95% CI: 7.3 to -4.7]) explained by a minor improvement in Cluster 1: (6.2 points) and no changes in Cluster 2: (0.2 points). Comparable results were found across the secondary outcomes. Clinically irrelevant cluster changes in IP were seen. Conclusion: In a cohort of people with knee pain, IP phenotype (i.e., Clusters) were of no prognostic value for the 2-year changes in pain, function, and QoL. Targeting IP may not be relevant in this patient population. Trial registration number and date of registration: The Frederiksberg Cohort study was pre-registered at clinicaltrials.gov (NCT03472300) on March 21, 2018.
ABSTRACT
OBJECTIVE: To explore the comparative effectiveness of pharmacological interventions for hand osteoarthritis (OA). METHODS: We systematically searched Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials from inception until 26 December 2021, for randomised trials of pharmacological interventions for people with hand OA. Two reviewers independently extracted study data and assessed the risk of bias. We calculated the effect sizes for pain (standardised mean differences) using Bayesian random effects models for network meta-analysis (NMA) and pairwise meta-analysis. Based on a pre-specified protocol, we prospectively registered the study at PROSPERO, CRD42021215393. RESULTS: We included 72 trials with 7609 participants. 65 trials (n=5957) were eligible for the quantitative synthesis, investigating 29 pharmacological interventions. Oral non-steroidal anti-inflammatory drugs (NSAIDs) and oral glucocorticoids' NMA effect sizes were -0.18 (95% credible interval -0.36 to 0.02) and -0.54 (-0.83 to -0.24), respectively, compared with placebo, and the result was consistent when limiting evidence to the pairwise meta-analysis of trials without high risk of bias. Intra-articular hyaluronate, intra-articular glucocorticoids, hydroxychloroquine, and topical NSAIDs' NMA effect sizes were 0.22 (-0.08 to 0.51), 0.25 (0.00 to 0.51), -0.01 (-0.19 to 0.18), and -0.14 (-0.33 to 0.08), respectively, compared with placebo. Oral NSAIDs were inferior to oral glucocorticoids with an NMA effect size of 0.36 (0.01 to 0.72). No intervention was superior to placebo when stratifying for thumb and finger OA. CONCLUSION: Oral NSAIDs and glucocorticoids are apparently effective pharmacological interventions in hand OA. Intra-articular therapies and topical NSAIDs were not superior to placebo.
Subject(s)
Glucocorticoids , Osteoarthritis , Humans , Bayes Theorem , Network Meta-Analysis , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Osteoarthritis/drug therapy , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE: Compare the effectiveness of a problem-solving, individualised, home-based occupational therapy intervention (ABLE 2.0), to usual occupational therapy, on activities of daily living (ADL) ability in persons with chronic conditions. DESIGN: A single-centre, double-blinded, randomised controlled trial with 10- and 26-week follow-up. SETTING: A Danish municipality. SUBJECTS: Persons with chronic conditions experiencing problems performing ADL tasks (n = 80). INTERVENTIONS: ABLE 2.0 was compared with usual occupational therapy. MAIN MEASURES: Coprimary outcomes were self-reported ADL ability (ADL-Interview Performance) and observed ADL motor ability (Assessment of Motor and Process Skills) at Week 10. Secondary outcomes were self-reported ADL ability (ADL-Interview Performance) and observed ADL motor ability (Assessment of Motor and Process Skills) at Week 26, and perceived satisfaction with ADL ability (ADL-Interview Satisfaction) and observed ADL process ability (Assessment of Motor and Process Skills) at Weeks 10 and 26. RESULTS: In total, 78 persons were randomly assigned: 40 to usual occupational therapy and 38 to ABLE 2.0. No statistically significant nor clinically relevant difference between group mean changes in primary outcomes was identified from baseline to Week 10 (ADL-Interview Performance [-0.16; 95% CI: -0.38 to 0.06] and Assessment of Motor and Process Skills ADL motor ability [-0.1; 95% CI: -0.3 to 0.1]). At Week 26, a statistically significant and clinically relevant difference was found in Assessment of Motor and Process Skills ADL motor ability (LS mean change: -0.3; 95% CI: -0.5 to -0.1) between groups. CONCLUSION: ABLE 2.0 was effective in improving observed ADL motor ability at 26 weeks.
ABSTRACT
BACKGROUND: Inhaled corticosteroids (ICS) are the cornerstone of asthma treatment. However, ICS has side effects, and dose reduction is recommended when possible. Physical exercise improves asthma control, but it is unknown whether it reduces the reliance on ICS. OBJECTIVE: To assess whether supervised high-intensity interval training reduces the need for ICS in untrained asthma patients. METHODS: An assessor-blinded single-center randomized controlled trial, Copenhagen, Denmark. One hundred fifty untrained ICS-treated adults with symptomatic asthma were randomly assigned (2:1) to 6 months of supervised exercise 3 times weekly or a lifestyle as usual control group. Every second month, a clinical algorithm based on symptom control was applied in both groups to adjust ICS dose. Primary outcome was the proportion who had their ICS dose reduced by 25% or more after 6 months. Secondary outcomes included actual ICS dosage in micrograms per day. RESULTS: Between October 2017 and December 2019, 102 patients were allocated to exercise intervention (86% completed) and 48 to the control (85% completed). At the 6-month visit, 63% versus 50% met the primary outcome in the exercise and control groups, respectively (adjusted risk difference 9.6% [95% CI -3.8 to 18.8]; P = .15). Daily ICS dose was reduced in favor of the exercise group, with a mean difference of -234 µg (95% CI -391 to -77; P = .0037), corresponding to a 24% reduction from baseline. This effect was sustained at 12 months. The intervention was safe and well tolerated. CONCLUSIONS: Six months of regular exercise results in reduction in daily ICS dose without compromising asthma control.