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Objective: To investigate the efficacy and safety of an oral complementary medicine combination formulation relative to placebo, on changes in pain intensity from baseline to week 12, in people with knee osteoarthritis (OA). Design: A placebo-controlled, double-blind, two-arm, superiority, phase II, Randomized Controlled Trial (RCT) (ACTRN12623000380695). We will recruit 82 participants (∼41 per arm), aged ≥40 years, with a clinical diagnosis of symptomatic knee OA and radiographic change on x-ray (Kellgren-Lawrence Grade ≥2). Participants will be randomly allocated to receive either a complementary medicine formulation containing a daily dose of Boswellia serrata extract (Boswellin® Super, 250 ​mg/day), pine bark extract (Fenoprolic™ 70 Organic 100 ​mg/day), curcumin (500 ​mg/day), piperine (5 ​mg/day), and methylsulfonylmethane (MSM, 1500 ​mg/day), or placebo, for 12-weeks. The primary endpoint will be change from baseline in average knee pain intensity at 12-weeks (visual analogue scale). Secondary endpoints will include change in knee pain from baseline to 12-weeks in the Knee Injury and Osteoarthritis Outcome Score (KOOS), global assessment of disease activity, global rating of change, and health-related quality of life (AQoL-8D). Ethics and dissemination: This protocol has been approved by the University of Sydney Human Research Ethics Committee (#2021/877). Dissemination will occur through lay summaries, infographics, conference abstracts, oral presentations, theses, and scientific publications. Conclusion: This RCT will provide credible evidence about the efficacy and safety of this complementary medicine combination and inform updates to international clinical practice standards on the use of complementary medicines in the management of symptomatic knee OA.

Objective: The Joint Effort Initiative (JEI) is an international collaboration of clinicians, researchers, and consumer organisations with a shared vision of improving the implementation of osteoarthritis management programs (OAMPs). This study aimed to identify JEI's future priorities and guide direction. Design: A two-part international survey to prioritise topics of importance to our membership and research stakeholders. Survey one presented a list of 40 topics under 5 themes. Consenting participants were asked to choose their top three topics in each theme. A short list of 25 topics was presented in survey two. Participants were asked to rank the importance (100-point NRS scale, 100 ​= ​highest priority). Response frequency (median, IQR) was used to rank the top priorities by theme. Results: Ninety-five participants completed survey one (61% female, 48% clinicians) and 57 completed survey two. The top ranked topic/s were:i. Promotion and advocacy: support training for health professionals (median 85, IQR 24).ii. Education and training: incorporating behaviour change into OAMPs (80, 16), advanced OA skills (80, 30), and integration of OA education into clinical training (80, 36).iii. Improving OAMPs delivery: regular updates on changes to best-evidence OA care (84, 24).iv. Future research: improve uptake of exercise, physical activity, and weight-loss (89, 16).v. Enhancing relationships, alliances, and shared knowledge: promote research collaborations (81, 30), share challenges and opportunities for OAMP implementation (80, 23). Conclusions: These topics will set the JEI's research and collaboration agenda for the next 5 years and stimulate ideas for others working in the field.

The “Joint Effort Initiative” (JEI) is an international consortium of clinicians, researchers, and consumers under the auspices of the Osteoarthritis Research Society International (OARSI). The JEI was formed with a vision to improve the implementation of coordinated programs of best evidence osteoarthritis care globally. To better understand some of the issues around osteoarthritis care in low- and middle-income countries (LMICs), the JEI invited clinician researcher representatives from South Africa, Brazil, and Nepal to discuss their perspectives on challenges and opportunities to implementing best-evidence osteoarthritis care at the OARSI World Pre-Congress Workshop. We summarize and discuss the main themes of the presentations in this paper. The challenges to implementing evidence-based osteoarthritis care identified in LMICs include health inequities, unaffordability of osteoarthritis management and the failure to recognize osteoarthritis as an important disease. Fragmented healthcare services and a lack of health professional knowledge and skills are also important factors affecting osteoarthritis care in LMICs. We discuss considerations for developing strategies to improve osteoarthritis care in LMICs. Existing opportunities may be leveraged to facilitate the implementation of best-evidence osteoarthritis care. We also discuss strategies to support the implementation, such as the provision of high-quality healthcare professional and consumer education, and systemic healthcare reforms.

Abstract Background To increase the uptake of key clinical recommendations for non-surgical management of knee osteoarthritis (OA) and improve patient outcomes, we developed a new model of service delivery (PARTNER model) and an intervention to implement the model in the Australian primary care setting. We will evaluate the effectiveness and cost-effectiveness of this model compared to usual general practice care. Methods We will conduct a mixed-methods study, including a two-arm, cluster randomised controlled trial, with quantitative, qualitative and economic evaluations. We will recruit 44 general practices and 572 patients with knee OA in urban and regional practices in Victoria and New South Wales. The interventions will target both general practitioners (GPs) and their patients at the practice level. Practices will be randomised at a 1:1 ratio. Patients will be recruited if they are aged ≥45 years and have experienced knee pain ≥4/10 on a numerical rating scale for more than three months. Outcomes are self-reported, patient-level validated measures with the primary outcomes being change in pain and function at 12 months. Secondary outcomes will be assessed at 6 and 12 months. The implementation intervention will support and provide education to intervention group GPs to deliver effective management for patients with knee OA using tailored online training and electronic medical record support. Participants with knee OA will have an initial GP visit to confirm their diagnosis and receive management according to GP intervention or control group allocation. As part of the intervention group GP management, participants with knee OA will be referred to a centralised multidisciplinary service: the PARTNER Care Support Team (CST). The CST will be trained in behaviour change support and evidence-based knee OA management. They will work with patients to develop a collaborative action plan focussed on key self-management behaviours, and communicate with the patients’ GPs. Patients receiving care by intervention group GPs will receive tailored OA educational materials, a leg muscle strengthening program, and access to a weight-loss program as appropriate and agreed. GPs in the control group will receive no additional training and their patients will receive usual care. Discussion This project aims to address a major evidence-to-practice gap in primary care management of OA by evaluating a new service delivery model implemented with an intervention targeting GP practice behaviours to improve the health of people with knee OA. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12617001595303, date of registration 1/12/2017.

Introduction First steps for knee osteoarthritis (OA) is a cluster randomised implementation trial examining the effect of an educational reminder message included in knee X-ray reports on the proportion of people subsequently referred to exercise professionals for their knee OA. Evaluating the processes supporting the completion of the study and the efficacy of the reminder message is essential to interpreting the outcomes of the study and aiding translation into practice.Methods and analysis We will conduct a concurrent process evaluation throughout the current study using a previously published framework for examining cluster randomised trials. This framework divides processes into those occurring at the cluster level and those at the target population level. For the current study, the cluster level is within radiology clinics. The target population is people with newly diagnosed radiologically evident, structural knee OA. A mixed methods design, incorporating survey data, administrative records, field notes and semi-structured interviews with representatives from radiology clinics and people with knee OA, will evaluate these processes. The focus of the evaluation will be recruitment and response processes of the radiology clinics and delivery and response processes for the people with knee OA. We will also describe the context and explore how the nudge theory of behavioural change influences the outcome of the study.Ethics and dissemination The study protocol, inclusive of the process evaluation, was approved by Macquarie University Human Research Ethics Committee (#520221190343842). Findings will be disseminated through national and international conferences, national industry stakeholders and patient advocacy groups to reach all levels of healthcare. Staff at radiology clinics and people with knee OA involved in interviews provide written, informed consent to participate in the process evaluation. Specific findings will be incorporated into training modules aimed at radiology clinics and will be developed by our industry partners.Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001414707p). Registration occurred in December 2022

ObjectiveNeighbourhood deprivation has been found to be associated with many health conditions, but its association with low back pain (LBP) and arthritis is unclear. This study aimed to examine the association between neighbourhood deprivation with LBP and arthritis, and its potential interaction with individual socioeconomic status (SES) on these outcomes.MethodsMonozygotic (MZ) twins from the Washington State Twin Registry were used to control for genetic and common environmental factors that could otherwise confound the purported relationship. Multilevel models were employed to examine the association between neighbourhood deprivation as well as individual-level SES with LBP/arthritis, adjusting for age, sex, body mass index (BMI) and residence rurality.ResultsThere were 6,380 individuals in the LBP sample and 2,030 individuals in the arthritis sample. Neighbourhood deprivation was not associated with LBP (P = 0.26) or arthritis (P = 0.61), and neither was its interaction with individual-level SES. People without a bachelor's degree were more likely to report LBP (OR 1.44, 95% CI 1.26-1.65) or both LBP and arthritis (OR 1.67, 95% CI 1.14-2.45) than those with a bachelor's degree, but not for arthritis alone (P = 0.17). Household income was not significantly associated with LBP (P = 0.16) or arthritis (p = 0.23) independent of age, sex, and BMI.ConclusionOur study did not find significant associations between neighbourhood deprivation and the presence of LBP or arthritis. More research using multilevel modelling to investigate neighbourhood effects on LBP and arthritis is recommended.

Introduction This cluster randomised implementation trial will assess the effect of two behavioural change interventions on the proportion of people with structural knee osteoarthritis (OA) referred and attending exercise-based professionals (physiotherapists and exercise physiologists). The interventions are designed to increase awareness of guidelines, benefits and access pathways for exercise therapy. We hypothesise either strategy will result in more people with knee OA being referred and attending physiotherapy/exercise physiology than current standard of care.Methods and analysis We will recruit 30 radiology clinics. 10 clinics will be randomly assigned to each trial arm with 1020 people with knee OA consecutively recruited (102 people per practice) into each arm. Intervention arm 1 is an educational reminder message targeted at primary care practitioners with a hyperlink to national guidelines regarding knee OA clinical management. It will be included in the reporting template of a plain knee X-ray. Intervention arm 2 is the reminder message and a patient-facing infographic explaining the benefits and access pathways for exercise. Both interventions will be delivered once, by the radiology clinics, when a person undergoes plain X-ray for non-traumatic knee pain/dysfunction. The primary outcome is referral to physiotherapist/exercise physiology. The secondary outcome is attendance to that appointment. Both outcomes are self-reported via an online survey administered 4 weeks after the X-ray. Additional survey questions explore facilitators and barriers to appointment attendance and acceptability of the interventions. A subsample of the intervention groups will be recruited for semistructured telephone-based interviews to further explore these latter outcomes.Ethics and dissemination The study protocol was approved by Macquarie University Human Research Ethics Committee (#520221190343842) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of the trial will be disseminated through peer-reviewed scientific journals and conferences. We will engage with Australian physician colleges and main-stream media to distribute findings.Trial registration number ACTRN12622001414707p.

Objective Implementation strategies, such as new models of service delivery, are needed to address evidence practice gaps. This paper describes the process of developing and operationalising a new model of service delivery to implement recommended care for people with knee osteoarthritis (OA) in a primary care setting.Methods Three development stages occurred concurrently and iteratively. Each stage considered the healthcare context and was informed by stakeholder input. Stage 1 involved the design of a new model of service delivery (PARTNER). Stage 2 developed a behavioural change intervention targeting general practitioners (GPs) using the behavioural change wheel framework. In stage 3, the ‘Care Support Team’ component of the service delivery model was operationalised.Results The focus of PARTNER is to provide patients with education, exercise and/or weight loss advice, and facilitate effective self-management through behavioural change support. Stage 1 model design: based on clinical practice guidelines, known evidence practice gaps in current care, chronic disease management frameworks, input from stakeholders and the opportunities and constraints afforded by the Australian primary care context, we developed the PARTNER service-delivery model. The key components are: (1) an effective GP consultation and (2) follow-up and ongoing care provided remotely (telephone/email/online resources) by a ‘Care Support Team’. Stage 2 GP behavioural change intervention: a multimodal behavioural change intervention was developed comprising a self-audit/feedback activity, online professional development and desktop software to provide decision support, patient information resources and a referral mechanism to the ‘Care Support Team’. Stage 3 operationalising the ‘care support team’—staff recruited and trained in evidence-based knee OA management and behavioural change methodology.Conclusion The PARTNER model is the result of a comprehensive implementation strategy development process using evidence, behavioural change theory and intervention development guidelines. Technologies for scalable delivery were harnessed and new primary evidence was generated as part of the process.Trial registration number ACTRN12617001595303 (UTN U1111-1197-4809)

Objectives Musculoskeletal pain is a leading cause of disability globally. In geographically and socioeconomically diverse countries, such as Australia, care seeking when someone experiences musculoskeletal pain is varied and potentially influenced by their individual characteristics, access to practitioners or perceived trustworthiness of information. This study explored how consumers currently access healthcare, how well it is trusted and if sociodemographic factors influenced healthcare utilisation.Design Anonymous online observational survey.Setting Australia.Participants A convenience sample of 831 community-based individuals (18+ years).Outcome measures Descriptive analyses and generalised estimating equations were used to quantify healthcare-seeking behaviours, sources and trust of health information for (A) first-contact practitioners, (B) medical practitioners, and (C) other sources of information.Results Of the 761 respondents, 73% were females, 54% resided in capital cities. 68% of respondents had experienced pain or injury in more than one lower limb joint. Despite this, more than 30% of respondents only sought help when there had not been natural resolution of their pain. Physiotherapists had the highest odds of being seen, asked and trusted for healthcare information. The odds of seeking care from general practitioners were no higher than seeking information from an expert website. Older individuals and women exhibited higher odds of seeking, asking and trusting health information.Conclusion Intelligible and trustworthy information must be available for consumers experiencing lower limb pain. Individuals, particularly younger people, are seeking information from multiple, unregulated sources. This suggests that healthcare professionals may need to invest time and resources into improving the trustworthiness and availability of healthcare information to improve healthcare quality.

IntroductionThis protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against ‘usual care’. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary ‘Care Support Team’. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability.Methods and analysisThe UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of ‘usual care’. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model.Ethics and disseminationThe primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context.Trial registration numberACTRN12617001595303; Pre-results.

Objective: Measurement of voluntary activation gives an indication of neural drive to the muscle. This study aimed to identify the site of impairment in neural drive during voluntary contractions post-stroke. Methods: Elbow-flexor voluntary activation was assessed bilaterally for 10 stroke patients (mean 61.2±12.3 years) and 6 age-matched controls (61.3±14.0 years) by stimulating either the peripheral nerve or the motor cortex during maximal voluntary contractions. Any additional evoked force during maximal contractions implies neural drive is incomplete. Peripheral stimulation can detect deficits at or above the stimulation level, while cortical stimulation can identify suboptimal supraspinal output. Results: Impairments were apparent on the less-affected side in addition to the more-affected side after stroke in voluntary activation, torque and EMG response. Maximal torque was reduced by 44% on the more-affected and 31% on the less-affected side compared to healthy controls (p

Sensation is commonly impaired immediately post-stroke but little is known about the long-term changes in cutaneous sensation that have the capacity to adversely impact independence and motor-function. We investigated cutaneous sensory thresholds across the hand in the chronic post-stroke period. Cutaneous sensation was assessed in 42 community-dwelling stroke patients and compared to 36 healthy subjects. Sensation was tested with calibrated monofilaments at 6 sites on the hand that covered the median, ulnar and radial innervation territories and included both glabrous (hairless) and hairy skin. The motor-function of stroke patients was assessed with the Wolf Motor Function Test and the upper-limb motor Fugl-Meyer Assessment. Impaired cutaneous sensation was defined as monofilament thresholds >3 SD above the mean of healthy subjects and good sensation was ≤ 3 SD. Cutaneous sensation was impaired for 33% of patients and was 40-84% worse on the more-affected side compared to healthy subjects depending on the site (p