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Abstract Background There is a need to increase the capacity and capability of musculoskeletal researchers to design, conduct, and report high-quality clinical trials. The objective of this study was to identify and prioritise clinical trial learning needs of musculoskeletal researchers in Australia and Aotearoa New Zealand. Findings will be used to inform development of an e-learning musculoskeletal clinical trials course. Methods A two-round online modified Delphi study was conducted with an inter-disciplinary panel of musculoskeletal researchers from Australia and Aotearoa New Zealand, representing various career stages and roles, including clinician researchers and consumers with lived experience of musculoskeletal conditions. Round 1 involved panellists nominating 3–10 topics about musculoskeletal trial design and conduct that they believe would be important to include in an e-learning course about musculoskeletal clinical trials. Topics were synthesised and refined. Round 2 asked panellists to rate the importance of all topics (very important, important, not important), as well as select and rank their top 10 most important topics. A rank score was calculated whereby higher scores reflect higher rankings by panellists. Results Round 1 was completed by 121 panellists and generated 555 individual topics describing their musculoskeletal trial learning needs. These statements were grouped into 37 unique topics for Round 2, which was completed by 104 panellists. The topics ranked as most important were: (1) defining a meaningful research question (rank score 560, 74% of panellists rated topic as very important); (2) choosing the most appropriate trial design (rank score 410, 73% rated as very important); (3) involving consumers in trial design through to dissemination (rank score 302, 62% rated as very important); (4) bias in musculoskeletal trials and how to minimise it (rank score 299, 70% rated as very important); and (5) choosing the most appropriate control/comparator group (rank score 265, 65% rated as very important). Conclusions This modified Delphi study generated a ranked list of clinical trial learning needs of musculoskeletal researchers. Findings can inform training courses and professional development to improve researcher capabilities and enhance the quality and conduct of musculoskeletal clinical trials.

Background: Knee osteoarthritis (OA) is a leading contributor to global disability, with exercise proven to be an effective treatment. Tai Chi is a recommended type of exercise, but it is primarily done in person which imposes an accessibility issue. This study aims to evaluate the effects of an online unsupervised program, when provided with online educational information and exercise adherence support, on changes in knee pain and physical function, when compared to online education control for people with knee OA. Methods: A two-arm, superiority parallel-design, pragmatic randomised controlled trial will be conducted involving 178 people with a clinical diagnosis of knee OA. After completing baseline assessment, participants will be randomly assigned to either: i) “My Joint Education”, an education control website containing OA information only; or ii) “My Joint Tai Chi”, an intervention website containing the same information as the control, a 12-week unsupervised online Tai Chi program to be undertaken at home 3 times a week, and information about an exercise adherence support app. All participants will be reassessed at 12 weeks after randomisation. Primary outcomes are overall knee pain during walking and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Discussion: This randomised controlled trial will provide evidence about the effectiveness of the “My Joint Tai Chi” website compared to “My Joint Education” website on self-reported knee pain and physical function for people with knee OA. Trial registration: Prospectively registered with the Australia New Zealand Clinical Trials Registry (ID: ACTRN12623000780651) on 18th July 2023.

Abstract Background Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA. Methods A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m2, aged

Abstract Background Hip osteoarthritis (OA) is a leading global cause of chronic pain and disability. Given there is no cure for OA, patient self management is vital with education and exercise being core recommended treatments. However, there is under-utilisation of these treatments due to a range of clinician and patient factors. Innovative service models that increase patient accessibility to such treatments and provide support to engage are needed. This study primarily aims to determine the effects of a self-directed digital exercise intervention comprising online education and exercise supported by a mobile app to facilitate adherence on the primary outcomes of changes in hip pain during walking and patient-reported physical function at 24-weeks when compared to online education control for people with hip OA. Methods We will conduct a two-arm, superiority parallel-design, randomised controlled trial involving 182 community volunteers aged 45 years and over, with painful hip OA. After completing the baseline assessment, participants will be randomly assigned to either: i) digital exercise intervention; or ii) digital education (control). Participants randomised to the intervention group will have access to a website that provides information about hip OA and its management, advice about increasing their physical activity levels, a 24-week lower limb strength exercise program to be undertaken at home three times per week, and a mobile app to reinforce home exercise program adherence. Participants in the control group will have access to a website containing only information about hip OA and its management. All participants will be reassessed at 24 weeks after randomisation. Primary outcomes are severity of hip pain while walking using an 11-point numeric rating scale and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes are the Hip dysfunction and Osteoarthritis Outcome Score subscales of pain, hip-related quality of life, and function, sports and recreational activities; global change in hip condition; health-related quality of life; measures of physical activity levels; fear of movement; self efficacy for pain and for exercise; and use of oral pain medications. Discussion Innovative and scalable approaches to OA education, physical activity, and exercise are required in order to improve exercise participation/engagement and mitigate physical inactivity in the hip OA population. This will help minimise the burden of this major public health issue on individuals and society. Trial registration Australia New Zealand Clinical Trials Registry (ACTRN12622001533785).

Abstract Background Telehealth has emerged as an alternative model for treatment delivery and has become an important component of health service delivery. However, there is inconsistency in the use of terminologies and a lack of research priorities in telehealth in musculoskeletal pain. The purpose of this international, multidisciplinary expert panel assembled in a modified three-round e-Delphi survey is to achieve a consensus on research priorities and for the standard terminology for musculoskeletal pain telehealth practice. Methods In this international modified e-Delphi survey, we invited an expert panel consisting of researchers, clinicians, consumer representatives, industry partners, healthcare managers, and policymakers to participate in a three-round e-Delphi. Expert panels were identified through the Expertscape website, PubMed database, social media, and a snowball approach. In Round 1, potential research priorities and terminologies were presented to panel members. Panel members rated the agreement of each research priority on a 5-point Likert scale and an 11-point numerical scale, and each terminology on a 5-point Likert scale for the "telehealth in musculoskeletal pain " field over rounds. At least 80% of the panel members were required to agree to be deemed a consensus. We analyzed the data descriptively and assessed the stability of the results using the Wilcoxon matched-pairs signed rank test. Results We performed an international e-Delphi survey from February to August 2022. Of 694 invited people, 160 panel members participated in the first round, 133 in the second round (83% retention), and 134 in the third round (84% retention). Most of the panel members were researchers 76 (47%), clinicians 57 (36%), and consumer representatives 9 (6%) of both genders especially from Brazil 31 (19%), India 22 (14%), and Australia 19 (12%) in the first round. The panel identified fourteen telehealth research priorities spanned topics including the development of strategies using information and communication technology, telehealth implementation services, the effectiveness and cost-effectiveness of telehealth interventions, equity of telehealth interventions, qualitative research and eHealth literacy in musculoskeletal pain conditions from an initial list of 20 research priorities. The consensus was reached for "digital health" and "telehealth" as standard terminologies from an initial list of 37 terminologies. Conclusion An international, multidisciplinary expert consensus recommends that future research should consider the 14 research priorities for telehealth musculoskeletal pain reached. Additionally, the terms digital health and telehealth as the most appropriate terminologies to be used in musculoskeletal telehealth research. Register Open Science Framework ( https://osf.io/tqmz2/ ).

Abstract Background Osteoarthritis (OA) is a prevalent, chronic joint condition that commonly affects the knee and hip causing pain, impaired function, and reduced quality of life. As there is no cure, the main goal of treatment is to alleviate symptoms via ongoing self-management predominantly consisting of exercise and weight loss (if indicated). However, many people with OA do not feel adequately informed about their condition and management options to self-manage effectively. Patient education is recommended by all OA Clinical Practice Guidelines to support appropriate self-management, but little is known about the optimal delivery method and content. Massive Open Online Courses (MOOCs) are free, interactive, e-learning courses. They have been used to deliver patient education in other chronic health conditions but have not been used in OA. Methods A two-arm parallel-design, assessor- and participant-blinded superiority randomised controlled trial. People with persistent knee/hip pain consistent with a clinical diagnosis of knee/hip OA (n = 120) are being recruited from the Australia-wide community. Participants are randomly allocated into one of two groups i) electronic information pamphlet (control group) or ii) MOOC (experimental group). Those allocated to the control group receive access to an electronic pamphlet about OA and its recommended management, currently available from a reputable consumer organisation. Those allocated to the MOOC receive access to a 4-week 4-module interactive consumer-facing e-Learning course about OA and its recommended management. Course design was informed by behaviour theory and learning science, and consumer preferences. The two primary outcomes are OA knowledge and pain self-efficacy with a primary endpoint of 5 weeks and a secondary endpoint of 13 weeks. Secondary outcomes include measures of fear of movement, exercise self-efficacy, illness perceptions, OA management and health professional care seeking intentions, physical activity levels, and actual use of physical activity/exercise and weight loss, pain medication, and health professional care seeking to manage joint symptoms. Clinical outcomes and process measures are also collected. Discussion Findings will determine whether a comprehensive consumer-facing MOOC improves OA knowledge and confidence to self-manage joint pain compared to a currently available electronic OA information pamphlet. Trial registration Prospectively registered (Australian New Zealand Clinical Trials Registry ID: ACTRN12622001490763).

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.

Abstract Background Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options. Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate ‘stable supportive’ shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled trial (RCT) aims to determine if stable supportive footwear reduces hip pain during walking compared to flat flexible footwear in people with chronic hip pain consistent with OA. Methods This trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures. Discussion This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.

Objective To evaluate effects of general osteoarthritis (OA) information in addition to a treatment option grid and general practitioner (GP) recommendation to exercise on treatment beliefs and intentions. Methods An online randomized trial of 735 people 45 years old or older without OA who were recruited from a consumer survey network. Participants read a hypothetical scenario about visiting their GP for knee problems and were randomized to the following: i) ‘general information', ii) ‘option grid' (general information plus option grid), or iii) ‘option grid plus recommendation' (general information plus option grid plus GP exercise recommendation). The primary outcome was an agreement that exercise is the best management option (0‐10 numeric rating scale; higher scores indicating higher agreement that exercise is best). The secondary outcomes were beliefs about other management options and management intentions. Linear regression models estimated the mean (95% confidence interval [CI]) between‐group difference in postintervention scores, adjusted for baseline. Results Option grid plus recommendation led to higher agreement that exercise is the best management by a mean of 0.4 units (95% CI: 0.1‐0.6) compared with general information. There were no other between‐group differences for the primary outcome. Option grid led to higher agreement that surgery was best, and x‐rays were necessary, compared with general information (mean between‐group differences: 0.7 [CI: 0.2‐1.1] and 0.5 [CI: 0.1‐1.0], respectively) and option grid plus recommendation (0.5 [CI: 0.1‐0.9] and 0.9 [CI: 0.4‐1.3]). Conclusion Addition of an option grid and GP exercise recommendation to general OA information led to more favorable views that exercise was best for the hypothetical knee problem. However, differences were small and of unclear clinical importance.

Objectives: To describe adherence to a 12-week web-based aerobic exercise programme, to compare characteristics between those who adhere or not, and to identify barriers for exercising in patients with hip or knee osteoarthritis. Design: Single-arm feasibility study. Subjects: Patients with hip or knee osteoarthritis in specialist healthcare, age 40–80 years, and not candidates for joint surgery. Methods: Adherence to a 12-week exercise programme was defined as having completed ≥ 2 exercise sessions a week for at least 8 weeks. Baseline differences between adherent and non-adherent groups in demographics, symptoms, disability, physical activity and fitness were assessed using Mann–Whitney U or χ2 tests. Reasons for not completing exercise sessions were reported in weekly diaries. Results: A total of 29 patients (median age 64 years, 72% female) were included. Median baseline pain (numerical rating scale 0–10) was 5. Fifteen patients adhered to the exercise programme, 14 did not. Non-adherent patients were less active (p = 0.032) and had lower cardiorespiratory fitness (p = 0.031). The most frequently reported barrier to exercising was sickness. Less than 10% reported pain as a barrier. Conclusion: Half of the patients with hip or knee osteoarthritis adhered to the digitally delivered exercise programme and the most frequently reported barrier for adherence was sickness, while less than 10% reported pain as a reason for not exercising. Trial registration: ClinicalTrials.gov, NCT04084834. The Regional Committee for Medical and Health Research Ethics South-East, 2018/2198.

Abstract Background In people with knee osteoarthritis (OA), ongoing exercise participation, particularly with strengthening exercises, is central to management. Patient adherence to prescribed exercise typically declines once consultations with a clinician have ceased. Mobile applications (apps) can incorporate behaviour change techniques that may assist adherence, potentially optimising clinical outcomes. Methods This is a two-arm, pragmatic, superiority randomised trial. One hundred and eighty two Australians with chronic knee pain (clinical knee OA) and who have at least a mild level of physical dysfunction are being recruited. Participants are randomly allocated i) exercise (physiotherapist-prescribed exercise) or; ii) exercise plus app (physiotherapist-prescribed exercise plus access to the ‘My Exercise Messages’ mobile app). Exercise care comprises two videoconferencing consultations with a physiotherapist over two weeks (30 min each) for a strengthening exercise program, which is then conducted independently at home for 24 weeks without any further physiotherapist consultations. Participants are also provided with exercise resources to facilitate home-based exercise. Those randomised to exercise plus app will download the app after completing the two weeks of physiotherapy consultations and will be instructed by research staff to use the app for the 24 weeks of unsupervised home-based exercises. The app works by tracking completion of weekly exercise sessions, providing regular messages to facilitate weekly exercise and providing personalised messages to help overcome individual barriers to exercise participation. The two primary outcomes are i) self-reported physical function; and ii) number of days strengthening exercises were performed (previous fortnight), with a primary endpoint of 26 weeks and a secondary endpoint of 14 weeks. Secondary outcomes include knee pain severity; knee-related quality of life; global change; exercise program satisfaction; exercise self-efficacy; physical activity; sport and recreation function; another measure of exercise adherence; and willingness to undergo joint replacement. Process measures are also included. Discussion Findings will determine if a theory-informed mobile app improves exercise adherence and physical function in people with knee OA who have received a home-based strengthening program. Trial Registration Australian New Zealand Clinical Trials Registry, ACTRN12621000724875. Prospectively registered 9/06/2021.

Abstract Background Patient organisations may be an under-utilised resource in follow-up of patients requiring long-term exercise as part of their disease management. The purpose of this study was to explore the feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis (OA). Methods In this pre–post feasibility study, patients aged 40–80 years with hip and/or knee OA were recruited from Diakonhjemmet Hospital. The 12-week intervention was delivered through a patient organisation’s digital platform. Feasibility was evaluated by proportion of eligible patients enrolled, proportion of enrolled patients who provided valid accelerometer data at baseline, and proportion completing the cardiorespiratory exercise test according to protocol at baseline and completed follow-up assessments. Patient acceptability was evaluated for website usability, satisfaction with the initial exercise level and comprehensibility of the exercise program. Change in clinical outcomes were assessed for physical activity, cardiorespiratory fitness and patient-reported variables. Results In total, 49 eligible patients were identified and 35 were enrolled. Thirty (86%) of these attended baseline assessments and provided valid accelerometer data and 18 (51%) completed the maximal cardiorespiratory exercise test according to protocol. Twenty-two (63%) patients completed the follow-up questionnaire, and they rated the website usability as ‘acceptable’ [median 77.5 out of 100 (IQR 56.9, 85.6)], 19 (86%) reported that the initial exercise level was ‘just right’ and 18 (82%) that the exercise program was ‘very easy’ or ’quite easy’ to comprehend. Improvement in both moderate to vigorous physical activity (mean change 16.4 min/day; 95% CI 6.9 to 25.9) and cardiorespiratory fitness, VO2peak (mean change 1.83 ml/kg/min; 95% CI 0.29 to 3.36) were found in a subgroup of 8 patients completing these tests. Across all patient-reported outcomes 24–52% of the patients had a meaningful improvement (n = 22). Conclusion A web-based exercise program delivered by a patient organisation was found to be feasible and acceptable in patients with hip and/or knee OA. Trial registration ClinicalTrials.gov, NCT04084834 (registered 10 September 2019). The Regional Committee for Medical and Health Research Ethics south-east, 2018/2198. URL: Prosjekt #632074 - Aktiv med web-basert støtte. - Cristin (registered 7 June 2019).

Abstract Background Obesity is associated with knee osteoarthritis (OA). Weight loss, alongside exercise, is a recommended treatment for individuals with knee OA and overweight/obesity. However, many patients cannot access weight loss specialists such as dietitians. Innovative care models expanding roles of other clinicians may increase access to weight loss support for people with knee OA. Physiotherapists may be well placed to deliver such support. This two-group parallel, superiority randomized controlled trial aims to compare a physiotherapist-delivered diet and exercise program to an exercise program alone, over 6 months. The primary hypothesis is that the physiotherapist-delivered diet plus exercise program will lead to greater weight loss than the exercise program. Methods 88 participants with painful knee OA and body mass index (BMI) > 27 kg/m2 will be recruited from the community. Following baseline assessment, participants will be randomised to either exercise alone or diet plus exercise groups. Participants in the exercise group will have 6 consultations (20–30 min) via videoconference with a physiotherapist over 6 months for a strengthening exercise program, physical activity plan and educational/exercise resources. Participants in the diet plus exercise group will have 6 consultations (50–75 min) via videoconference with a physiotherapist prescribing a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating, plus the intervention of the exercise only group. Outcomes are measured at baseline and 6 months. The primary outcome is percentage change in body weight measured by a blinded assessor. Secondary outcomes include self-reported knee pain, physical function, global change in knee problems, quality of life, physical activity levels, and internalised weight stigma, as well as BMI, waist circumference, waist-to-hip ratio, physical performance measures and quadriceps strength, measured by a blinded assessor. Additional measures include adherence, adverse events, fidelity and process measures. Discussion This trial will determine whether a physiotherapist-delivered diet plus exercise program is more effective for weight loss than an exercise only program. Findings will inform the development and implementation of innovative health service models addressing weight management and exercise for patients with knee OA and overweight/obesity. Trial registration NIH US National Library of Medicine, Clinicaltrials.gov NCT04733053 (Feb 1 2021).

Abstract Background Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Most evidence is based on muscle-strengthening exercise, but aerobic physical activity has potential to enhance clinical benefits. The primary aim of this study is to test the hypothesis that adding aerobic physical activity to a muscle strengthening exercise leads to significantly greater reduction in hip pain and improvements in physical function, compared to a lower-limb muscle strengthening exercise program alone at 3 months. Methods This is a superiority, 2-group, parallel randomised controlled trial including 196 people with symptomatic hip OA from the community. Following baseline assessment, participants are randomly allocated to receive either i) aerobic physical activity and muscle strengthening exercise or; ii) muscle strengthening exercise only. Participants in both groups receive 9 consultations with a physiotherapist over 3 months. Both groups receive a progressive muscle strengthening exercise program in addition to advice about OA management. The aerobic physical activity plan includes a prescription of moderate intensity aerobic physical activity with a goal of attaining 150 min per week. Primary outcomes are self-reported hip pain assessed on an 11-point numeric rating scale (0 = ‘no pain’ and 10 = ‘worst pain possible’) and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale) at 3 months. Secondary outcomes include other measures of self-reported pain (assessed at 0, 3, 9 months), self-reported physical function (assessed at 0, 3, 9 months), performance-based physical function (assessed at 0, 3 months), joint stiffness (assessed at 0, 3, 9 months), quality of life (assessed at 0, 3, 9 months), muscle strength (assessed at 0, 3 months), and cardiorespiratory fitness (assessed at 0, 3 months). Other measures include adverse events, co-interventions, and adherence. Measures of body composition, serum inflammatory biomarkers, quantitative sensory measures, anxiety, depression, fear of movement and self-efficacy are included to explore causal mechanisms. Discussion Findings will assist to provide an evidence-based recommendation regarding the additional effect of aerobic physical activity to lower-limb muscle strengthening on hip OA pain and physical function. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN 12619001297112. Registered 20th September 2019.

Abstract Background Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Despite some clinical guidelines also recommending weight loss for hip OA, there is no evidence from randomised controlled trials (RCT) to substantiate these recommendations. This superiority, 2-group, parallel RCT will compare a combined diet and exercise program to an exercise only program, over 6 months. Methods One hundred people with symptomatic and radiographic hip OA will be recruited from the community. Following baseline assessment, participants will be randomly allocated to either, i) diet and exercise or; ii) exercise only. Participants in the diet and exercise group will have six consultations with a dietitian and five consultations with a physiotherapist via videoconferencing over 6 months. The exercise only group will have five consultations with a physiotherapist via videoconferencing over 6 months. The exercise program for both groups will include prescription of strengthening exercise and a physical activity plan, advice about OA management and additional educational resources. The diet intervention includes prescription of a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating. Primary outcome is self-reported hip pain via an 11-point numeric rating scale (0 = ‘no pain’ and 10 = ‘worst pain possible’) at 6 months. Secondary outcomes include self-reported body weight (at 0, 6 and 12 months) and body mass index (at 0, 6 and 12 months), visceral fat (measured using dual energy x-ray absorptiometry at 0 and 6 months), pain, physical function, quality of life (all measured using subscales of the Hip Osteoarthritis Outcome Scale at 0, 6 and 12 months), and change in pain and physical activity (measured using 7-point global rating of change Likert scale at 6 and 12 months). Additional measures include adherence, adverse events and cost-effectiveness. Discussion This study will determine whether a diet intervention in addition to exercise provides greater hip pain-relief, compared to exercise alone. Findings will assist clinicians in providing evidence-based advice regarding the effect of a dietary intervention on hip OA pain. Trial registration ClinicalTrials.gov . Identifier: NCT04825483 . Registered 31st March 2021.

Abstract Background There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. Methods A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. Discussion This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. Trial registration Australian and New Zealand Clinical Trials Registry ( ANZCTR ) Registration date: 10/12/2018.

Abstract Background First metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years. Non-drug, non-surgical treatments are recommended by OA clinical guidelines, yet there have only ever been two randomised controlled trials (RCTs) evaluating such strategies in people with first MTP joint OA. Foot orthoses are a common non-drug, non-surgical strategy used by allied health professionals for people with first MTP joint OA, however, it is unknown whether these devices are effective in improving the symptoms associated with the condition. This clinical trial aimed to determine whether contoured foot orthoses lead to greater reductions in first MTP joint pain on walking compared to sham flat insoles in people with first MTP joint OA. Methods The FORT trial (Foot ORthoses for big Toe joint osteoarthritis) is a two-arm participant- and assessor-blinded, multi-site RCT conducted in Melbourne, Sydney, Brisbane and the Gold Coast, Australia. We are recruiting 88 community-dwelling people with symptomatic radiographic first MTP joint OA. Following baseline assessment, participants are randomized to receive either: i) contoured foot orthoses; or ii) sham flat insoles following baseline assessment. Participants have two visits with a study podiatrist where they are provided with their allocated insoles, to be worn daily for 12 weeks at all times when wearing shoes. The primary outcome is self-reported first MTP joint pain on walking (numerical rating scale), assessed at baseline and 12 weeks. Secondary outcomes include additional measures of first MTP joint and foot pain, physical function, quality of life, participant-perceived global ratings of change (pain and function), and level of physical activity. Discussion This study will provide novel evidence about whether contoured foot orthoses improve pain and other symptoms compared to sham insoles in people with first MTP joint OA. Outcomes will help to inform clinical guidelines and practice about the use of foot orthoses for managing symptoms in this under-researched group of people with OA. Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry (reference: ACTRN12619000926134 ) on 3/07/2019.

Abstract Background Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services. Methods This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30–45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes (health-related quality of life; therapeutic relationship; global ratings of change; satisfaction with care; self-efficacy; physical activity levels), time and financial costs of attending consultations, healthcare usage and convenience. Non-inferiority will be assessed using the per-protocol dataset. Discussion Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12619001240134. http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377672&isReview=true

Abstract Background Structural features of lateral tibiofemoral (TF) joint osteoarthritis (OA) occur in up to half of all people with knee OA, and co-existing lateral TF OA is associated with worse knee pain in people with mixed compartmental knee OA. Clinical guidelines for management of knee OA advocate advice about appropriate footwear, yet there is no research evaluating which types of footwear are best for managing pain associated with lateral TF OA. Biomechanical evidence suggests that “motion-control” footwear, which possess midsoles that are stiffer medially compared to laterally, may shift load away from the lateral compartment of the knee and thus may reduce knee pain associated with lateral TF OA. The primary aim of this study is to compare the effects of motion-control shoes to neutral shoes on knee pain in people with predominantly lateral TF OA. Methods This will be an assessor- and participant-blinded, two-arm, comparative effectiveness randomized controlled trial (RCT) conducted in Melbourne, Australia. We will recruit a minimum of 92 people with painful lateral TF OA from the community. Participants will be randomly allocated to receive either motion-control shoes or neutral shoes and will be instructed to wear their allocated shoes for a minimum of 6 h per day for 6 months. The primary outcome is change in self-reported knee pain on walking, measured using a numerical rating scale, assessed at baseline and 6 months. Secondary outcomes include other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity levels. Discussion This study will compare the efficacy of motion-control shoes to neutral shoes for people with painful lateral TF OA. Findings will be the first to provide evidence of the effects of footwear on knee pain in this important subgroup of people with knee OA and allow clinicians to provide accurate advice about the most appropriate footwear for managing pain associated with lateral TF OA. Trial registration This trial has been prospectively registered by the Australian New Zealand Clinical Trials Registry on 15/11/2018 (reference: ACTRN12618001864213 ).

Abstract Background There is no physiotherapy-specific quality indicator tool available to evaluate physiotherapy care for people with hip and/or knee osteoarthritis (OA). This study aimed to develop a patient-reported quality indicator tool (QUIPA) for physiotherapy management of hip and knee OA and to assess its reliability and validity. Methods To develop the QUIPA tool, quality indicators were initially developed based on clinical guideline recommendations most relevant to physiotherapy practice and those of an existing generic OA quality indicator tool. Draft items were then further refined using patient focus groups. Test-retest reliability, construct validity (hypothesis testing) and criterion validity were then evaluated. Sixty-five people with hip and/or knee OA attended a single physiotherapy consultation and completed the QUIPA tool one, twelve- and thirteen-weeks after. Physiotherapists (n = 9) completed the tool post-consultation. Patient test-retest reliability was assessed between weeks twelve and thirteen. Construct validity was assessed with three predefined hypotheses and criterion validity was based on agreement between physiotherapists and participants at week one. Results A draft list of 23 clinical guideline recommendations most relevant to physiotherapy was developed. Following feedback from three patient focus groups, the final QUIPA tool contained 18 items (three subscales) expressed in lay language. The test-retest reliability estimates (Cohen’s Kappa) for single items ranged from 0.30–0.83 with observed agreement of 64–94%. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI) for the Assessment and Management Planning subscale was 0.70 (0.54, 0.81), Core Recommended Treatments subscale was 0.84 (0.75, 0.90), Adjunctive Treatments subscale was 0.70 (0.39, 0.87) and for the total QUIPA score was 0.80 (0.69, 0.88). All predefined hypotheses regarding construct validity were confirmed. However, agreement between physiotherapists and participants for single items showed large measurement error (Cohen’s Kappa estimates ranged from − 0.04-0.59) with the ICC (95% CI) for the total score being 0.11 (− 0.14, 0.34). Conclusions The QUIPA tool showed acceptable test-retest reliability for subscales and total score but inadequate reliability for individual items. Construct validity was confirmed but criterion validity for individual items, subscales and the total score was inadequate. Further research is needed to refine the QUIPA tool to improve its clinimetric properties before implementation.

Abstract Background Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. Methods Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and

Abstract Background First metatarsophalangeal (MTP) joint osteoarthritis (OA) is a common and painful problem that causes significant disability. There is limited research on assessment and treatment options, and the efficacy of current management strategies is unknown. The aim of this study was to determine how podiatrists and physical therapists in Australia and the United Kingdom (UK) manage people with first MTP joint OA. Methods A survey of podiatrists and physiotherapists was conducted. Potential respondents were recruited through professional representative organisations in Australia and the UK. Participants completed a bespoke online survey regarding the assessment and treatment approaches they most commonly use for patients with first MTP joint OA. Descriptive statistics were calculated and differences between professions compared using chi-square. Results Two hundred respondents (n = 113 (57%) podiatrists and n = 140 (70%) from Australia) completed the survey. Assessment tests were similar between professions and included x-ray (n = 151/164; 92%), range of motion (n = 127/141; 90%), and a pain scale (n = 78/99; 79%). Podiatrists were more likely than physical therapists to discuss over-the-counter medication (42% vs 17%; p

Objective: (i) Compare the feasibility of three load modification strategies to immediately increase hip contact force in people with hip osteoarthritis (OA) using real-time visual biofeedback during walking, and (ii) prospectively evaluate changes in pain and physical function following 6-weeks of walking using a prescribed personalised load modification strategy. Design: Twenty participants with symptomatic mild-to-moderate hip OA walked on an instrumented treadmill while motion capture and electromyographic data were recorded (normal walk), then under three conditions: (i)neutral trunk lean; (ii)neutral pelvic obliquity; (iii)increased step length. The biomechanical parameter of interest and corresponding target value were displayed in real-time. Hip contact forces were subsequently computed using a calibrated electromyography-informed neuromusculoskeletal model. A decision tree was used to prescribe a personalised load modification strategy to each participant for integration into walking over 6-weeks. Results: Only the step length modification significantly increased peak hip contact force compared to normal walking when performed by all participants (11.34 [95%CI 4.54,18.13]%, P ​10%. After 6-weeks, 77% and 46% of participants reported a clinically important improvement in hip pain during walking and physical function, respectively. Conclusion: Most participants with hip OA could immediately increase hip contact force through personalised movement retraining by a magnitude estimated to promote cartilage heath and reported an improvement in symptoms after 6-weeks. Findings provide preliminary support for a personalised load modification-based intervention for hip OA.

Abstract Background Patellofemoral pain is highly prevalent across the lifespan, and a significant proportion of people report unfavourable outcomes years after diagnosis. Previous research has implicated patellofemoral joint loading during gait in patellofemoral pain and its sequelae, patellofemoral osteoarthritis. Biomechanical foot‐based interventions (e.g., footwear, insoles, orthotics, taping or bracing) can alter patellofemoral joint loads by reducing motions at the foot that increase compression between the patella and underlying femur via coupling mechanisms, making them a promising treatment option. This systematic review will summarise the evidence about the effect of biomechanical foot‐based interventions on patellofemoral joint loads during gait in adults with and without patellofemoral pain and osteoarthritis. Methods MEDLINE (Ovid), the Cumulative Index to Nursing and Allied Health Literature CINAHL, The Cochrane Central Register of Controlled Trials (CENTRAL), SPORTdiscus (EBSCO) and Embase (Ovid) will be searched. Our search strategy will include terms related to ‘patellofemoral joint’, ‘loads' and ‘biomechanical foot‐based interventions'. We will include studies published in the English language that assess the effect of biomechanical foot‐based interventions on patellofemoral joint loads, quantified by patellofemoral joint pressure, patellofemoral joint reaction force and/or knee flexion moment. Two reviewers will independently screen titles and abstracts, complete full‐text reviews, and extract data from included studies. Two reviewers will assess study quality using the Revised Cochrane Risk of Bias (RoB 2) tool or the Cochrane Risk Of Bias In Non‐Randomized Studies – of Interventions (ROBINS‐I) tool. We will provide a synthesis of the included studies' characteristics and results. If three or more studies are sufficiently similar in population and intervention, we will pool the data to conduct a meta‐analysis and report findings as standardised mean differences with 95% confidence intervals. If a meta‐analysis cannot be performed, we will conduct a narrative synthesis of the results and produce forest plots for individual studies. Discussion This protocol outlines the methods of a systematic review that will determine the effect of biomechanical foot‐based interventions on patellofemoral joint loads. Our findings will inform clinical practice by identifying biomechanical foot‐based interventions that reduce or increase patellofemoral joint loads, which may aid the treatment of adults with patellofemoral pain and osteoarthritis. Trial registration Registered with PROSPERO on the 4th of May 2022 (CRD42022315207).

Objectives This systematic review aimed to determine the effects of neuromuscular gait modification strategies on indicators of medial knee joint load in people with medial knee osteoarthritis. Methods Databases (Embase, MEDLINE, Cochrane Central, CINAHL and PubMed) were searched for studies of gait interventions aimed at reducing medial knee joint load indicators for adults with medial knee osteoarthritis. Studies evaluating gait aids or orthoses were excluded. Hedges’ g effect sizes (ES) before and after gait retraining were estimated for inclusion in quality-adjusted meta-analysis models. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results Seventeen studies (k = 17; n = 362) included two randomised placebo-controlled trials (RCT), four randomised cross-over trials, two case studies and nine cohort studies. The studies consisted of gait strategies of ipsilateral trunk lean (k = 4, n = 73), toe-out (k = 6, n = 104), toe-in (k = 5, n = 89), medial knee thrust (k = 3, n = 61), medial weight transfer at the foot (k = 1, n = 10), wider steps (k = 1, n = 15) and external knee adduction moment (KAM) biofeedback (k = 3, n = 84). Meta-analyses found that ipsilateral trunk lean reduced early stance peak KAM (KAM1, ES and 95%CI: -0.67, -1.01 to -0.33) with a dose-response effect and reduced KAM impulse (-0.37, -0.70 to -0.04) immediately after single-session training. Toe-out had no effect on KAM1 but reduced late stance peak KAM (KAM2; -0.42, -0.73 to -0.11) immediately post-training for single-session, 10 or 16-week interventions. Toe-in reduced KAM1 (-0.51, -0.81 to -0.20) and increased KAM2 (0.44, 0.04 to 0.85) immediately post-training for single-session to 6-week interventions. Visual, verbal and haptic feedback was used to train gait strategies. Certainty of evidence was very-low to low according to the GRADE approach. Conclusion Very-low to low certainty of evidence suggests that there is a potential that ipsilateral trunk lean, toe-out, and toe-in to be clinically helpful to reduce indicators of medial knee joint load. There is yet little evidence for interventions over several weeks.

Background Previous investigations on valgus knee bracing have mostly used the external knee adduction moment. This is a critical limitation, as the external knee adduction moment does not account for muscle forces that contribute substantially to the medial tibiofemoral contact force (MTCF) during walking. The aims of this pilot study were to: 1) determine the effect of a valgus knee brace on MTCF; 2) determine whether the effect is more pronounced after 8 weeks of brace use; 3) assess the feasibility of an 8-week brace intervention. Methods Participants with medial radiographic knee OA and varus malalignment were fitted with an Össur Unloader One© brace. Participants were instructed to wear the brace for 8 weeks. The MTCF was estimated via an electromyogram-assisted neuromuscular model with and without the knee brace at week 0 and week 8. Feasibility outcomes included change in symptoms, quality of life, confidence, acceptability, adherence and adverse events. Results Of the 30 (60% male) participants enrolled, 28 (93%) completed 8-week outcome assessments. There was a main effect of the brace (pConclusion Although significant, reductions in the peak MTCF and MTCF while wearing the knee brace were small. No effect of time on MTCF was observed. Although there were numerous minor adverse events, feasibility outcomes were generally favourable. Trial registration Australian and New Zealand Clinical Trials Registry (12619000622101).

Background Telehealth could enhance rehabilitation for people with chronic health conditions. This review examined the psychometric properties of performance-based measures of physical function administered via telehealth among people with chronic health conditions using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) approach. Methods This systematic review was registered with Prospero (Registration number: CRD42021262547). Four electronic databases were searched up to June 2022. Study quality was evaluated by two independent reviewers using the COSMIN risk of bias checklist. Measurement properties were rated by two independent reviewers in accordance with COSMIN guidance. Results were summarised according to the COSMIN approach and the modified GRADE approach was used to grade quality of the summarised evidence. Results Five articles met the eligibility criteria. These included patients with Parkinson’s Disease (n = 2), stroke (n = 1), cystic fibrosis (n = 1) and chronic heart failure (n = 1). Fifteen performance-based measures of physical function administered via videoconferencing were investigated, spanning measures of functional balance (n = 7), other measures of general functional capacity (n = 4), exercise capacity (n = 2), and functional strength (n = 2). Studies were conducted in Australia (n = 4) and the United States (n = 1). Reliability was reported for twelve measures, with all twelve demonstrating sufficient inter-rater and intra-rater reliability. Criterion validity for all fifteen measures was reported, with eight demonstrating sufficient validity and the remaining seven demonstrating indeterminate validity. No studies reported data on measurement error or responsiveness. Conclusions Several performance-based measures of physical function across the domains of exercise capacity, strength, balance and general functional capacity may have sufficient reliability and criterion validity when administered via telehealth. However, the evidence is of low-very low quality, reflecting the small number of studies conducted and the small sample sizes included in the studies. Future research is needed to explore the measurement error, responsiveness, interpretability and feasibility of these measures administered via telehealth.

Objective: Determine the feasibility of a 6-month exercise and weight management intervention for people with hip osteoarthritis (OA). Design: 18 participants with clinical and radiographic hip OA with a body mass index ≥28 ​kg/m2 and

Background: We aimed to describe trends in knee and hip OA management by general medical practitioners (GPs) in Australia. Methods: We analysed cross-sectional survey data from the Bettering the Evaluation and Care of Health (BEACH) program (1,000 randomly-selected GPs annually recording 100 consecutive patient encounters) over two periods: Period one April 1, 2005-March 31, 2010 and period two April 1, 2010-March 31, 2016. This included data from 10,738 GPs and 1,073,800 patient encounters with 6,565 GPs and 9,196 patient encounters for hip/knee OA. Data were summarized using descriptive statistics and 95% confidence intervals around point estimates. Findings: Rate of knee OA problems managed by GPs increased in period two (7•1 (6•9-7•4) vs 6•2 (95% CI 6•0-6•5) per 1,000 all encounters), with a similar trend for hip OA. Encounter rates rose for some subgroups but remained stable for vulnerable subgroups. Although use of Medicare chronic disease management items, referral to allied health professionals and advice/education and lifestyle management (knee OA) increased, rates remained low. Use of MRI imaging rose. Overall medication rates were stable but substantially higher than non-pharmacological treatments. Declining reliance on non-steroidal anti-inflammatory drugs and glucosamine and increased reliance on paracetamol (knee OA) and opioids were demonstrated. Interpretation: GPs in Australia are more frequently managing knee and hip OA. While small changes in GP management actions occured, rates of recommended first-line non-pharmacological treatments remained low and imaging, medications, and surgical referral rates high. Strategies are needed to optimise lifestyle management and reduce low-value care, with attention to healthcare disparities. Funding: Funding was provided for this report by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Translational Research in Musculoskeletal Pain (#1079078).

Abstract Background Knee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence. Methods We are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure. Discussion Findings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA. Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTRN12617001243303 Date/version: August 2019/two

Abstract Background Knee osteoarthritis (OA) is a prevalent and chronic condition with no known cure. Exercise is advocated in all clinical guidelines due to its positive effects on symptoms. Despite this, exercise participation is often poor in people with knee OA with access to exercise treatments a known barrier. Internet-delivered exercise interventions have the potential to improve access to evidence-based exercise treatments and can benefit OA outcomes, although non-usage and low adherence potentially limit their effectiveness. Short message services (SMS) show promise in facilitating exercise adherence and may be one solution to improve adherence to internet-delivered exercise interventions. The combination of internet-delivered exercise and SMS adherence support has not been specifically evaluated in people with knee OA. Methods This protocol reports a two-arm parallel-design, assessor- and participant-blinded randomised controlled trial. This trial is recruiting 206 people aged 45 years and older, with a clinical diagnosis of knee OA from the Australian-wide community. Eligible and consenting participants are enrolled and randomised to receive access to either i) ‘My Knee Education’, an education control website containing OA and exercise information only or ii) a combined intervention that includes a website, ‘My Knee Exercise’, containing the same educational information as the control, guidance to increase general physical activity, and the prescription of a 24-week self-directed home-based lower-limb strengthening program in addition to a 24-week behaviour change SMS exercise adherence program. Outcome measures are being collected at baseline and 24-weeks. Primary outcomes are self-reported knee pain and physical function. Secondary outcomes include another self-reported measure of knee pain, function in sport and recreation, quality-of-life, physical activity, self-efficacy, participant satisfaction and perceived global change. Discussion This randomised controlled trial will provide evidence about the effectiveness of a combined intervention of internet-delivered OA and exercise education, physical activity guidance and prescription of a 24-week lower-limb strengthening exercise program supported by a behaviour change SMS program compared to internet delivered OA and exercise education alone. Trial registration ACTRN12618001167257/13th July 2018.

Abstract Background Clinical guidelines recommend exercise as a core treatment for individuals with knee osteoarthritis (OA). However, the best type of exercise for clinical benefits is not clear, particularly in different OA subgroups. Obesity is a common co-morbidity in people with knee OA. There is some evidence suggesting that non-weight bearing exercise may be more effective than weight bearing exercise in patients with medial knee OA and obesity. Methods To compare the efficacy of two different exercise programs (weight bearing functional exercise and non-weight bearing quadriceps strengthening) on pain and physical function for people ≥50 years with painful medial knee OA and obesity (body mass index ≥30 kg/m2) 128 people in Melbourne, Australia will be recruited for a two group parallel-design, assessor- and participant-blinded randomised controlled trial. Participants will be randomly allocated to undertake a program of either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise. Both groups will attend five individual sessions with a physiotherapist who will teach, monitor and progress the exercise program. Participants will be asked to perform the exercises at home four times per week for 12 weeks. Outcomes will be measured at baseline and 12 weeks. Primary outcomes are self-reported knee pain and physical function. Secondary outcomes include other measures of knee pain, physical function, quality-of-life, participant-perceived global change, physical performance, and lower limb muscle strength. Discussion This study will compare the efficacy of two different 12-week physiotherapist-prescribed, home-based exercise programs for people with medial knee OA and obesity. Findings will provide valuable information to help inform exercise prescription in this common OA patient subgroup. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12617001013358, 14/7/2017

Abstract Background Higher peak external knee flexion moments (KFM) during running has been observed in healthy people wearing athletic footwear compared to barefoot, which may increase risk of knee pathologies such as patellofemoral pain. Currently, no studies have examined whether stability and neutral style athletic shoes influence the peak KFM differently, or explored the underlying biomechanical mechanisms by which footwear alters peak KFM in young females. Methods Lower limb biomechanics of sixty girls aged between 10 and 25 years old were collected while running in footwear (both stability and neutral) and barefoot. The external peak KFM, sagittal plane kinematics, sagittal plane knee ground reaction force (GRF) lever arm and sagittal plane resultant GRF magnitude were analysed by repeated measures Analysis of Variance. Linear mixed models were fit to identify predictors of a change in peak KFM, and to determine if the effects of these predictors differed between footwear conditions. Results The peak KFM was higher wearing both shoe styles compared to barefoot (p 0.05). Both shoes also increased kinematic variables at the hip, knee, and ankle (p

Objectives: 1) Develop unidimensional instruments to measure osteoarthritis (OA) knowledge among people with hip or knee OA, and 2) assess the structural validity, internal consistency, cross-cultural validity/measurement invariance, test-retest reliability, and measurement error of the Hip Osteoarthritis Knowledge Scale (HOAKS) and the Knee Osteoarthritis Knowledge Scale (KOAKS). Methods: Draft HOAKS and KOAKS were developed and refined following best-practice (COSMIN) guidelines with involvement of consumer research partners. Measurement properties of the HOAKS and KOAKS will be assessed through an online survey. The survey will include the novel HOAKS or KOAKS, the current short form of the Hip or Knee injury and Osteoarthritis Outcome Score (HOOS-12/KOOS-12), and items that gather demographic and OA characteristics and explore self-rated OA knowledge. People will be eligible to participate if aged 18 years and older, can communicate in English, and have either hip or knee OA as diagnosed by a health professional or by meeting diagnostic criteria. We aim to obtain 400 complete HOAKS or KOAKS responses and 100 complete HOAKS or KOAKS retest responses one week after initial completion. Rasch analysis will estimate structural validity, internal consistency and cross-cultural validity/measurement invariance. Assessment will include test-retest reliability (intraclass correlation coefficient) and absolute measurement error (standard error of measurement; smallest detectable change). Conclusion: This study will produce robust unidimensional instruments to measure hip and knee OA knowledge. We anticipate that the HOAKS and KOAKS scales will be useful in clinical and research settings to identify knowledge gaps or evaluate interventions designed to improve knowledge.

Abstract Background Higher landing-related external knee joint moments at later stages of female pubertal development likely contribute to a higher incidence of non-contact anterior cruciate ligament (ACL) injury. Athletic footwear may provide a potential strategy to alter higher knee moments. Methods Thirty-one late/post-pubertal girls (Tanner stage IV-V, menarche and growth spurt attained) performed a single limb drop lateral jump in three footwear conditions (barefoot, low support shoes and high support shoes), in which peak knee abduction moment (KAbM), flexion moment (KFM) and internal rotation moments (KIRM) were measured. Repeated measures ANOVA and ANCOVA were used to test for a main effect of footwear with and without foot posture index (FPI) as a covariate (p

Abstract Background Knee osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability globally, and abnormal knee loading is central to disease pathogenesis. Clinical guidelines recommend clinicians provide advice regarding appropriate footwear for people with knee OA, yet there is little research comparing the effects of different footwear on knee OA symptoms. Research suggests that wearing flat flexible shoes is associated with lower knee joint loads compared to stable supportive shoe styles. This two-arm pragmatic, comparative effectiveness randomised controlled trial will compare the effects of daily use of flat flexible shoes and stable supportive shoes on knee OA clinical outcomes, over 6 months. Methods 164 people with symptomatic medial tibiofemoral OA of moderate to severe radiographic severity (Kellgren and Lawrence Grade 3 & 4) will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either i) flat flexible shoes or; ii) stable supportive shoes. Participants will choose two different pairs of shoes from a selection that fulfil the criteria in their allocated shoe class. Limited disclosure will blind participants to group allocation. Participants will be instructed to wear their allocated shoes daily for 6 months (minimum of 6 h/day), after which participants will be reassessed. The primary outcomes are knee pain severity on walking (measured by numerical rating scale) and self-reported physical function (measured by the Western Ontario and McMaster Universities Osteoarthritis Index), assessed at baseline and 6 months. Secondary outcomes include additional measures of knee pain, function, sport and recreation participation and quality-of-life (measured using subscales of the Knee Osteoarthritis Outcome Score), as well as pain at other sites (measured by numerical rating scale), self-reported global ratings of change in pain and physical function (measured by 7-point rating scale), and physical activity levels (measured by Physical Activity Scale for the Elderly). Discussion This study will determine whether daily wear of flat flexible shoes improves clinical outcomes in the management of knee OA, compared to stable supportive shoes. Findings will assist clinicians in providing evidence-based advice regarding appropriate footwear for people with knee OA to self-manage symptoms. Trial registration Australian New Zealand Clinical Trials Registry reference: ACTRN12617001098325. Registered 28/07/2017.

Abstract Background Knee ‘unloading’ footwear can reduce the external knee adduction moment in people with knee osteoarthritis, yet effects of these shoes on regional plantar forces are unknown. We evaluated the effects of unloading shoes on in-shoe regional plantar forces, and whether measures of foot posture and/or mobility moderate these effects in people with symptomatic knee osteoarthritis. Methods In this exploratory study 21 participants underwent testing while wearing knee unloading shoes (ASICS GEL-Melbourne OA) and conventional shoes in random order. Peak total forces were compared across conditions for: lateral heel, medial heel, lateral forefoot, and medial forefoot. Arch index, centre of pressure position and medial-lateral heel peak force ratio were also evaluated. Foot posture, foot mobility magnitude and navicular drop were separately added to the mixed linear model to investigate if these modified the effect of footwear on outcomes. Results Unloading shoes significantly increased lateral heel and lateral forefoot force (12.9 and 20.2% respectively, all P

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.

Abstract Background Most adults fail to meet global physical activity guidelines set out by the World Health Organization. In recent years, behavioural economic principles have been used to design novel interventions that increase physical activity. Immediate financial rewards, for instance, can motivate an individual to change physical activity behaviour by lowering the opportunity costs of exercise. This systematic review will summarise the evidence about the effectiveness of financial incentive interventions for improving physical activity in adults. Methods We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, Scopus, PsycINFO, EconLit, SPORTDiscus, the National Health Service Economic Evaluation Database, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform from inception using a comprehensive, electronic search strategy. The search strategy will include terms related to ‘financial incentive’ and ‘physical activity’. Only randomised controlled trials that investigate the effect of financial incentives on physical activity in adult populations and that are written in the English language will be included. Two review authors will independently screen abstracts and titles, complete full text reviews and extract data on objective and self-reported physical activity outcomes. The authors will also assess the study quality using the Cochrane risk of bias tool and provide a systematic presentation and synthesis of the included studies’ characteristics and results. If more than two studies are sufficiently similar in population, settings and interventions, we will pool the data to conduct a meta-analysis. If we are unable to perform a meta-analysis, we will conduct a narrative synthesis of the results and produce forest plots for individual studies. Our subgroup analyses will examine the differential effects of an intervention in healthy populations compared to populations with disease pathology and compare the effects of interventions using financial rewards to interventions using financial penalties. Discussion This systematic review will determine the effectiveness of positive and negative financial incentives on physical activity in adults. Findings will help inform the development of public health interventions and research in this field. Systematic review registration PROSPERO 2017: CRD42017068263

Abstract Background Clinical guidelines recommend knee muscle strengthening exercises to improve physical function. However, the amount of knee muscle strength increase needed for clinically relevant improvements in physical function is unclear. Understanding how much increase in knee muscle strength is associated with improved physical function could assist clinicians in providing appropriate strength gain targets for their patients in order to optimise outcomes from exercise. The aim of this study was to investigate whether an increase in knee muscle strength is associated with improved self-reported physical function following exercise; and whether the relationship differs according to physical function status at baseline. Methods Data from 100 participants with medial knee osteoarthritis enrolled in a 12-week randomised controlled trial comparing neuromuscular exercise to quadriceps strengthening exercise were pooled. Participants were categorised as having mild, moderate or severe physical dysfunction at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Associations between 12-week changes in physical function (dependent variable) and peak isometric knee extensor and flexor strength (independent variables) were evaluated with and without accounting for baseline physical function status and covariates using linear regression models. Results In covariate-adjusted models without accounting for baseline physical function, every 1-unit (Nm/kg) increase in knee extensor strength was associated with physical function improvement of 17 WOMAC units (95% confidence interval (CI) −29 to −5). When accounting for baseline severity of physical function, every 1-unit increase in knee extensor strength was associated with physical function improvement of 24 WOMAC units (95% CI −42 to −7) in participants with severe physical dysfunction. There were no associations between change in strength and change in physical function in participants with mild or moderate physical dysfunction at baseline. The association between change in knee flexor strength and change in physical function was not significant, irrespective of baseline function status. Conclusions In patients with severe physical dysfunction, an increase in knee extensor strength and improved physical function were associated. Trial registration ANZCTR 12610000660088 . Registered 12 August 2010.

Abstract Background Pronated foot posture is associated with many clinical and biomechanical outcomes unique to medial compartment knee osteoarthritis (OA). Though shoe-worn insole treatment, including lateral wedges, is commonly studied in this patient population, their effects on the specific subgroup of people with medial knee OA and concomitant pronated feet are unknown. The purpose of this study was to evaluate whether lateral wedge insoles with custom arch support are more beneficial than lateral wedge insoles alone for knee and foot symptoms in people with medial tibiofemoral knee osteoarthritis (OA) and pronated feet. Methods Twenty-six people with pronated feet and symptomatic medial knee OA participated in a randomized crossover study comparing five degree lateral wedge foot insoles with and without custom foot arch support. Each intervention was worn for two months, separated by a two-month washout period of no insoles wear. Main outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales, the revised short-form Foot Function Index (FFI-R) pain and stiffness subscales, and the timed stair climb test. Regression modeling was conducted to examine treatment, period, and interaction effects. Results Twenty-two participants completed the study, and no carryover or interaction effects were observed for any outcome. Significant treatment effects were observed for the timed stair climb, with greater improvements seen with the lateral wedges with arch support. Within-condition significant improvements were observed for WOMAC pain and physical function, as well as FFI-R pain and stiffness with lateral wedges with arch support use. More adverse effects were reported with the lateral wedges alone, while more people preferred the lateral wedges with arch support overall. Conclusions Addition of custom arch support to a standard lateral wedge insole may improve foot and knee symptoms in people with knee OA and concomitant pronated feet. These preliminary findings suggest further research evaluating the role of shoe-worn insoles for treatment of this specific sub-group of people with knee OA is warranted. Trial registration Clinicaltrials.gov identifier: NCT02234895 .