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Background Contextual effects (i.e., placebo response ) refer to all health changes resulting from administering an apparently inactive treatment. In a randomized clinical trial (RCT), the overall treatment effect (i.e., the post-treatment effect in the intervention group) can be regarded as the true effect of the intervention plus the impact of contextual effects. This meta-research was conducted to examine the average proportion of the overall treatment effect attributable to contextual effects in RCTs across clinical conditions and treatments and explore whether it varies with trial contextual factors. Methods Data was extracted from trials included in the main meta-analysis from the latest update of the Cochrane review on “ Placebo interventions for all clinical conditions” (searched from 1966 to March 2008). Only RCTs reported in English having an experimental intervention group, a placebo comparator group, and a no-treatment control group were eligible. Results In total, 186 trials (16,655 patients) were included. On average, 54% (0.54, 95%CI 0.46 to 0.64) of the overall treatment effect was attributable to contextual effects. The contextual effects were higher for trials with blinded outcome assessor and concealed allocation. The contextual effects appeared to increase proportional to the placebo effect, lower mean age, and proportion of females. Conclusion Approximately half of the overall treatment effect in RCTs seems attributable to contextual effects rather than to the specific effect of treatments. As the study did not include all important contextual factors (e.g., patient-provider interaction), the true proportion of contextual effects could differ from the study’s results. However, contextual effects should be considered when assessing treatment effects in clinical practice. Trial registration PROSPERO CRD42019130257 . Registered on April 19, 2019.

EULAR’s 2023 updated recommendations for the non-pharmacological treatment of hip and knee osteoarthritis reiterates and confirms, in an abbreviated form, what we have known for more than a decade. Unfortunately, the abbreviated format of the updated recommendations lacks specificity and clinical usefulness. More detailed guidance could have facilitated wider uptake and improved care.

Background Knee osteoarthritis is a highly prevalent and painful joint disorder with limited long-term treatment options. Intra-articular corticosteroids and hyaluronic acid offer only short-term relief and may have safety concerns. This study aimed to evaluate the long-term effectiveness and safety of a single intra-articular injection of 2.5% polyacrylamide hydrogel in individuals with moderate to severe knee osteoarthritis. Methods This prospective, multicentre, open-label, single-arm clinical study enrolled 49 participants who received a single 6 mL intra-articular injection of 2.5% polyacrylamide hydrogel. After 1 year, 35 participants entered an extension study with yearly assessments up to 5 years post treatment. The primary outcomes for the extension phase included changes from baseline in WOMAC subscales (pain, stiffness, physical function) and Patient Global Assessment (PGA). Safety was evaluated through the incidence of adverse events. Statistical analyses included a mixed model for repeated measures and sensitivity analyses using ANCOVA and baseline observation carried forward. Results Of the 49 participants, 27 completed the five-year follow-up. Statistically significant improvements from baseline were observed in WOMAC pain (−14.6; 95% CI: −21.4 to −7.7; p  = 0.0002), stiffness (−19.6; 95% CI: −29.9 to −9.3; p  = 0.0006), physical function (−12.5; 95% CI: −19.8 to −5.2; p  = 0.0015), and PGA (−13.4; 95% CI: −23.3 to −3.5; p  = 0.0100). These improvements were sustained throughout the five-year period. A total of 47 adverse events were reported in the extension study, with no serious events attributed to the investigational device. No new adverse device effects were reported in the extension study. Conclusions A single intra-articular injection of 2.5% polyacrylamide hydrogel demonstrated sustained improvements in WOMAC pain, stiffness, physical function, and PGA for up to five years, with a favourable safety profile. These findings support its potential as a long-term treatment option for knee osteoarthritis. Trial registration ClinicalTrials.gov Identifier: NCT04179552.

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.

Background People with hand-related rheumatoid arthritis (RA) experience problems performing activities of daily living (ADL). Compensatory strategies to improve ADL ability have shown effective. Similarly, hand exercise has shown effect on pain, grip strength, and self-reported ability. A combination has shown positive effects based on self-report, but self-report and observation provide distinct information about ADL. The purpose of this study was to examine whether hand exercise as add on to compensatory intervention (CIP) will improve observed ADL ability in RA. Methods Women ( n  = 55) with hand-related RA were randomized to CIP EXERCISE (intervention) or CIP only (control). CIP is focused on joint protection, assistive devices, and alternative ways of performing AD. The hand-exercise program addressed range of motion and muscle strength. Primary outcome was change in observed ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS). Baseline measures were repeated after 8 weeks. Results Improvements in ADL motor ability in CIP EXERCISE (mean change = 0.24 logits; 95% CI = 0.09 to 0.39) and CIP CONTROL (mean change =0.20 logits; 95% CI = 0.05 to 0.35) were statistically significant, with no differences between groups (mean difference = 0.04 logits; 95% CI = − 0.16 to 0.25). Thirteen (46.4%) participants in the CIP EXERCISE and 12 (44.4%) in the CIP CONTROL obtained clinically relevant improvements (≥ 0.30 logits) in ADL motor ability; this group difference was not significant ( z  = 0.15; p  = 0.88). Conclusion Adding hand exercise to a compensatory intervention did not yield additional benefits in women with hand-related RA. The study was approved by the ethics committee 14th of April 2014 (H-3-2014-025) and registered at ClinicalTrials.gov 16th of May 2014 (NCT02140866).

ObjectiveTo provide an overview of the effects of exercise for osteoarthritis.DesignOverview.Data sourcesMedline, Embase, Epistemonikos, PEDro, Cochrane and registries from inception to 8 November 2025.Eligibility criteriaReviews comparing exercise with placebo, no intervention or other interventions on pain and function for osteoarthritis. Supplementary trials were included to update inconclusive areas.Data extraction and synthesisTwo independent reviewers extracted data and assessed bias. Data were standardised to a 0–100 scale and reanalysed using random-effects meta-analysis. Certainty was rated using Grading of Recommendations Assessment, Development and Evaluation.ResultsFive reviews (κ=100; n=8631) and 28 supplementary trials (knee/hip κ=23, hand κ=3, ankle κ=2; n=4360) were included. Evidence indicated small, short-term effects of exercise versus placebo (mean difference −10.8, 95% CI −19.1 to −2.6) and no-treatment (−12.4, 95% CI −15.6 to −9.2) for knee osteoarthritis pain, but certainty was very low and effects in larger or longer-term trials were smaller. Moderate evidence suggested negligible effects in hip (−6.7 95% CI −9.3 to −4.0) and small effects in hand (−10.0 95% CI −15.5 to −4.5) osteoarthritis. Varying certainty evidence indicated comparable outcomes to education, manual therapy, analgesics, injections and arthroscopy. Single trials in selected populations showed exercise was less effective than knee osteotomy (12.4 95% CI 4.7 to 20.2) and joint replacement (knee 17.1 95% CI 10.4 to 23.8; hip 24.2 95% CI 18.2 to 30.2) at longer term.Conclusion and relevanceEvidence on exercise for osteoarthritis remains largely inconclusive, suggesting negligible or short-lasting small effects comparable to, or less effective than, other treatments. These findings question its universal promotion and highlight the need to revisit research priorities and clinical discussions around its worthwhileness.RegistrationCRD42023446888.

Assessment of knee kinematics plays an important role in the clinical examination of patients with patellofemoral pain (PFP). There is evidence that visual assessments are reliable in healthy subjects, but there is a lack of evidence in injured populations. The purpose of this study was to examine the intra- and interrater agreement in the visual assessment of dynamic knee joint alignment in patients with PFP. The study was a cross-sectional agreement study. Sixty participants (42 females) were included. We assessed the intra- and interrater agreement of two functional tests: The single leg squat (SLS) and the forward lunge (FL). One investigator scored the movement according to preset criteria while video recording the movement for retest. Moreover, the performance was scored by another investigator using the video recording. Agreement was assessed using weighted kappa statistics. The intrarater agreement ranged from moderate to good (Kappa 0.58 (FL) to 0.70 (SLS)) whereas the interrater agreement ranged from fair to moderate (Kappa 0.22 (SLS) to 0.50 (FL)). The agreement within raters was better than between raters, which suggests that assessments should preferably be performed by the same tester in research and in a clinical setting, e.g., to evaluate any treatment effect. We promote FL as a reliable clinical tool for evaluating dynamic knee alignment, since it shows equally good intra- and interrater agreement, and it is an inexpensive and easy method to use.

Knee arthroplasty (KA) is commonly used for osteoarthritis of the knee joint and it is a highly successful procedure. Still, KA leaves 20% of patients dissatisfied with their outcome. The purpose of this study was to determine if a prognosis made by physiotherapists at the orthopaedic wards during the first post-operative days could predict the 6- and 12-months outcome of KA. Physiotherapists at two orthopaedic wards in Denmark were asked to predict the 6- and 12-months outcome of the KA patients they have treated post-operatively on a 0-10 scale (10 representing the best prognosis). At 6 and 12 months post-operatively the patients answered the Oxford Knee Score (OKS), EuroQol 5D-3L and Patient Acceptable Symptom State (PASS). Multivariable logistic regression analyses were performed to assess the prediction of PASS and treatment success. We assessed predictive performance by examining measures of calibration and discrimination. A total of 361 patients were included. The models for PASS and Treatment Success showed poor to acceptable discriminative values (OR between 1.47 and 1.92 and areas under the curves of 0.62-0.73), however the calibration plots indicated significant uncertainties in the prediction. Physiotherapists prognoses of recovery after KA are associated with 6- and 12-months patient reported outcomes and satisfaction but have weak predictive value. This study suggests that physiotherapists' prognoses may be useful as an additional source of information when identifying patients in need of additional post-operative care.

ObjectiveRelationships between patient education and long-term clinical outcomes are complex. This study used real-world data to evaluate the impact of improved pain knowledge on clinical outcomes in fibromyalgia patients.MethodsProspectively collected registry-based observational data were analysed to emulate a randomised clinical trial. Study participants were diagnosed with fibromyalgia, had a high need to learn about pain (Numeric Rating Scale >7), had attended a 2-day therapeutic educational programme and re-rated their learning needs after the programme. A good educational outcome was defined as a re-rating score <5, while a poor outcome was ≥5. The primary endpoint at 9 months was the overall impact of fibromyalgia, measured by the Fibromyalgia Impact Questionnaire Revised (FIQR) impact subscale.ResultsThe eligible cohort comprised 450 participants. The intention-to-treat from population included 121 participants (26.9%) with a good educational outcome and 329 participants (73.1%) with a poor educational outcome (comparator group). Missing outcome data were handled implicitly by the repeated measures linear mixed models, assuming data are missing at random.At the 9-month endpoint, the fully adjusted FIQR impact subscale score was lower in the good educational outcome group (8.0 (95% CI 7.3 to 8.7)) compared with the poor educational outcome group (9.6 (95% CI 9.0 to 10.2)), indicating a better clinical outcome for those with a good educational outcome. The model-estimated between-group difference was −1.6 (95% CI −2.5 to −0.7; p=0.0006) FIQR impact subscale units.ConclusionsThis study suggests that achieving pain educational learning objectives leads to better clinical outcomes in fibromyalgia patients, supporting the integration of pain education into patient programmes.

Illness perception is related to management patterns and pain intensity, but among elderly with low back pain, this relation is unclear. The aims of this study were to analyse the associations between illness perception, pain intensity and health related quality of life in a group of elderly with low back pain and explore how different illness perception profiles would cluster and differ in terms of pain, quality of life and choice of management. This was a cross-sectional survey based on a cohort of originally 640 Danish children. Of the 311 respondents in 2019, 69% reported low back pain within last year and were included. Associations between illness perceptions (Brief illness perception questionnaire), health related quality of life (EuroQol-5 Domain-3L) and low back pain intensity were assessed, and participants were clustered based on their perceptions using hierarchical and K-means cluster analysis. Cluster differences in pain, quality of life and use of pharmacological and non-pharmacological treatments were explored. Among the 213 individuals with low back pain, 33% reported severe or fluctuating pain intensity. Higher pain intensity was associated with perceiving low back pain as a greater threat. Participants reporting fluctuating pain perceived their low back pain almost as threatening as participants reporting severe pain. Two clusters were identified. Cluster 1 reported lower quality of life (difference in medians: -0.176 (95% CI [-0.233--0.119 ])) and was more likely to report severe or fluctuating pain (37.7% vs. 4.5% [  < 0.0001]) and to use pharmacological treatments than Cluster 2 (37.7% vs. 14.9% [  < 0.001]). No association was found between clusters concerning use of non-pharmacological treatments (  = 0.134). Based on illness perceptions, two clusters differing in pain intensity, quality of life and use of pharmacological treatments were identified. Targeting illness perceptions may be beneficial during rehabilitation or when guiding patients with low back pain in choice of management.