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Abstract Introduction Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high‐quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA. Methods This will be a parallel‐group randomised controlled superiority trial. One‐hundred and forty community‐dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11‐point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester–Oxford Foot Questionnaire), participants' perception of overall treatment effect (self‐reported global rating of change on a 15‐point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health‐related quality of life (Short Form‐12 Version® 2.0), use of co‐interventions and adverse events. Discussion This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health‐related quality of life in people with midfoot OA. The findings will provide high‐quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA. Trial registration Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

Abstract Background Little is known about factors that influence footwear selection by field hockey players. Methods An online survey was used to collect data on participant demographics and physical characteristics, factors influencing footwear selection, perceptions regarding footwear design features on injury and performance, and experiences regarding usability. Nominal and ordinal data were described as absolute frequencies and relative frequencies. Free text responses were analysed using content analysis. Sex‐related differences in quantitative and qualitative data were explored. Results A total of 401 hockey players completed the survey. Participants reported that fit, comfort, support, and cushioning were the most important factors when selecting hockey footwear. Most hockey players believed that stud design could influence athletic performance (65%) and injury risk (63%) but reported having no preference on outsole design or stud shape. Most participants (63%) used hockey‐specific footwear, but 46% of female hockey players did not, with 40% using trail running footwear instead. Qualitative analysis revealed that hockey players, particularly female participants, encounter difficulties finding properly fitting footwear. They desire more options for wide or narrow feet and face challenges in accessing suitable hockey shoes due to limited choices and availability. Conclusions With over a third of field hockey players not using hockey‐specific footwear, future research should attempt to understand the reasons and assess the impact of different footwear features on comfort, performance, injury risk, and usability.

Abstract Background Burnout is highly prevalent among health practitioners. It negatively impacts job performance, patient care, career retention and psychological well‐being. This study aimed to identify factors associated with burnout among Australian podiatrists. Methods Data were collected from registered podiatrists via four online surveys administered annually from 2017 to 2020 as part of the Podiatrists in Australia: Investigating Graduate Employment (PAIGE) study. Information was collected about work history, job preferences, personal characteristics, health, personality, life experiences and risk‐taking behaviours. Multiple logistic regression analyses were used to determine if (i) individual characteristics, (ii) workplace factors and (iii) job satisfaction measures were associated with burnout (based on the abbreviated Maslach Burnout Inventory). Results A total of 848 responses were included, with 268 podiatrists (31.6%) experiencing burnout. Participants experiencing burnout were slightly younger, more recent to practice, had poorer health, greater mental distress, lower scores for resilience, extraversion, agreeableness, conscientiousness, emotional stability and openness to experiences. They were less likely to have financial and clinical risk‐taking behaviour and more likely to have career risk‐taking behaviour. Prediction accuracy of these individual characteristic variables for burnout was 72.4%. Participants experiencing burnout were also more likely to work in private practice, have more work locations, work more hours, more direct patient hours, see more patients, have shorter consultation times, more likely to bulk bill chronic disease management plans, have less access to sick leave and professional development and be more likely to intend to leave patient care and the profession within 5 years than participants not experiencing burnout. Prediction accuracy of these workplace‐related variables for burnout was 67.1%. Participants experiencing burnout were less satisfied with their job. Prediction accuracy of these variables for burnout was 78.8%. Conclusions Many of the factors associated with burnout in Australian podiatrists are modifiable, providing opportunities to implement targeted prevention strategies. The strength of association of these factors indicates high potential for strategies to be successful.

Abstract Background Running retraining is commonly used in the management of medial tibial stress syndrome (MTSS) but evidence for its effectiveness is lacking. The primary aim of this study is to determine if the addition of running retraining to best standard care is beneficial in the management of runners with MTSS. Methods This study is an assessor‐blinded and participant‐blinded, parallel‐group, randomised controlled trial. The trial will recruit 64 participants aged between 18 and 45 years, with a clinical diagnosis of MTSS that has affected their running participation for at least four weeks. Participants will be randomised to receive best standard care (control) or running retraining and best standard care (intervention group) over an 8‐week period. Best standard care will consist of load management advice, symptom management advice, footwear advice and a strengthening program. Running retraining will consist of a cue to reduce running step length. Outcomes will be measured at weeks 1, 2, 4 and 8. The primary outcome measure will be the University of Wisconsin Running Injury and Recovery Index at week 4. Secondary outcome measures include: (i) Exercise Induced Leg Pain Questionnaire—British Version, (ii) global rating of change scale, (iii) worst pain experienced during a run, (iv) weekly run volume, (v) reactive strength index score, (vi) single leg hop test, (vii) soleus single leg maximum voluntary isometric contraction, (viii) gastrocnemius single leg maximum voluntary isometric contraction, (ix) single leg plantar flexor endurance test, (x) running step length, and (xi) running step rate. Data will be analysed using the intention‐to‐treat principle. Discussion This randomised controlled trial will evaluate if reducing running step length provides additional benefit to best standard care in the management of runners with MTSS over an 8‐week period. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12624000230550.

Abstract Background Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). Methods COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. Conclusions This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. Trial registration This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081

Abstract This study aimed to compare health-related quality of life (HRQoL) in people with and without plantar heel pain (PHP). This was a cross-sectional observational study that compared 50 adult participants with PHP to 25 participants without PHP who were matched for age, sex and body mass index (BMI). HRQoL measures included a generic measure, the Short Form 36 version 2 (SF-36v2), and foot-specific measures, including 100 mm visual analogue scales (VASs) for pain, the Foot Health Status Questionnaire (FHSQ), and the Foot Function Index-Revised (FFI-R). Comparisons in HRQoL between the two groups were conducted using linear regression, with additional adjustment for the comorbidity, osteoarthritis, which was found to be substantially different between the two groups. For generic HRQoL, participants with PHP scored worse in the SF-36v2 physical component summary score (p

Abstract Background Ankle osteoarthritis (OA) is a debilitating health condition that is increasing in prevalence. Currently, there are no evidence-based guidelines for managing ankle OA. One of the current challenges to establishing guidelines is the lack of a widely agreed-upon set of outcome measures that are consistently used in ankle OA research. Without a set of agreed-upon outcome measures, it is difficult to synthesise clinical trial outcomes through meta-analysis—an essential element of evidence-informed practice. In order to develop an appropriate set of outcome measures for ankle OA, it is important first to develop a core domain set. In this protocol, we describe the methodological approach that we will use to develop such a core domain set for ankle OA. Methods We established an international steering committee to guide the development of a core domain set for ankle OA. The core domain set development will follow a multi-staged approach consisting of three phases, involving participation by patients and clinicians/healthcare professionals. In phase 1, a list of candidate domains will be gleaned from (a) a scoping review of outcome measures used in ankle OA research, (b) qualitative interviews with individuals with ankle OA, and (c) qualitative interviews with healthcare professionals with expertise in ankle OA. In phase 2, the steering committee will review and generate a list of candidate domains from those gleaned in phase 1. In phase 3, this list of candidate domains will be considered in a Delphi process to reach a consensus on a core domain set. We anticipated this will involve 3 rounds of surveys. Conclusion This protocol describes the methods that will be used to develop a core domain set of health-related aspects for ankle OA. Importantly, it will include both healthcare professional and patient involvement. This is a prerequisite step to developing a core outcome set for ankle OA that should be reported in all clinical trials for ankle OA. The findings will be widely disseminated across peer-refereed publication(s) and national and international conferences, as well as via relevant professional societies, patient support group organisations, and social media platforms. Project registration This project is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database on 17 March 2021. https://www.comet-initiative.org/Studies/Details/1837 .

Abstract Background Foot and lower limb health complications are common among patients undergoing dialysis; but a summary of prevention and management evidence is not available. The aim of this scoping review was to summarise study characteristics and the nature of results regarding strategies to prevent and manage peripheral arterial disease (PAD), foot ulceration, amputation, associated infection and associated hospital admission in adults undergoing dialysis. Methods MEDLINE, Embase, CINAHL and AMED databases were searched for longitudinal experimental and observational studies. Eligible studies included adults undergoing dialysis (≥10 dialysis patients, with separate results or ≥ 75% of the cohort). Any interventions relating to PAD, foot ulceration, amputation, associated infection, and associated hospital admission were included. Results The review included 212 studies, of which 199 were observational (94%) and 13 were experimental (6%). Sixteen studies (8%) addressed the prevention of foot and lower limb health complications, 43 (20%) addressed management, and 153 (72%) addressed both. The main intervention type in each study was surgery (n = 159, 75%), care from one or more health professionals (n = 13, 6%), screening by a health professional (n = 10, 5%), medication (n = 9, 4%) and rehabilitation (n = 5, 2%). No studies were identified where exercise, offloading or education were the main intervention. Results for PAD were reported in 137 (65%) studies, foot ulceration in 54 (25%), amputation in 171 (81%), infection in 7 (3%), and admission in 26 studies (12%). Results for more than one foot or lower limb outcome were reported in 141 studies (67%), with each study reporting on average two outcomes. Results varied and spanned positive, negative, and neutral outcomes following intervention. Conclusions Identified studies frequently aimed to both prevent and manage foot and lower limb health complications. A variety of interventions were identified and studies often reported results for more than one foot or lower limb health outcome. Findings from this review can be used to guide future research, with a goal to support improved patient outcomes.

Abstract Background Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aimed to determine the feasibility of conducting a parallel group randomised trial to evaluate the effectiveness of a nonsurgical intervention for reducing pain associated with hallux valgus. Methods Twenty‐eight community‐dwelling women with painful hallux valgus were randomised to receive either a multifaceted, nonsurgical intervention (footwear, foot orthoses, foot exercises, advice, and self‐management) or usual care (advice and self‐management alone). Outcome measures were obtained at baseline, 4, 8 and 12 weeks. The primary outcome was feasibility, evaluated according to demand (recruitment rate and conversion rate), acceptability, adherence, adverse events, and retention rate. Limited efficacy testing was conducted on secondary outcome measures including foot pain, foot muscle strength, general health‐related quality of life, use of cointerventions, and participants' perception of overall treatment effect. Results Between July 8, 2021, and April 22, 2022, we recruited and tested 28 participants (aged 44 to 80 years, mean 60.7, standard deviation 10.7). This period encompassed two COVID‐related stay‐at‐home orders (July 16 to July 27, and August 5 to October 21, 2021). The predetermined feasibility thresholds were met for retention rate, foot pain, mental health‐related quality of life, and use of cointerventions, partly met for acceptability, adverse events, and muscle strength, and not met for demand (recruitment rate or conversion rate), adherence, physical health‐related quality of life and perception of overall treatment effect. Conclusion In its current form, a randomised trial of footwear, foot orthoses, foot exercises, advice and self‐management for relieving pain associated with hallux valgus is not feasible, particularly due to the low adherence with the intervention. However, it is difficult to determine whether the trial would be feasible under different circumstances, particularly due to COVID‐19 stay‐at‐home orders. Future trials will need to consider improving the aesthetics of the footwear and making the exercise program less burdensome. Trial registration Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).

Abstract Background People with plantar heel pain (PHP) have reduced foot and ankle muscle function, strength and size, which is frequently treated by muscle strengthening exercises. However, there has been little investigation of what exercises are used and there is no sound evidence base to guide practice. This study aimed to develop a consensus‐driven progressive muscle strengthening program for PHP. Methods Thirty‐eight experts were invited to participate in the study over three rounds. Round 1 was an open‐ended questionnaire that provided the core characteristics of progressive strengthening programs designed for three different adult patient types with PHP (younger athletic, overweight middle‐aged, older), which were presented as vignettes. In Round 2, experts indicated their agreement to the proposed exercises and training variables. In Round 3, experts were presented with amendments to the exercises based on responses from Round 2 and indicated their agreement to those changes. Consensus was achieved when > 70% of experts agreed. Results Two experts were ineligible and 12 declined, leaving 24 (67%) who participated in Round 1. Eighteen (75%) completed all three rounds. From Round 1, progressive strengthening programs were developed for the three vignettes, which included 10 different exercises and three training variables (sets / repetitions, weight, and frequency). In Round 2, 68% (n = 17) of exercises and 96% (n = 72) of training variables reached consensus. In Round 3, only exercise changes were presented and 100% of exercises reached consensus. Conclusions This study provides three progressive strengthening programs agreed to by experts that can be used in future clinical trials to determine the effectiveness of muscle strengthening for PHP. In addition, clinicians could use the programs as part of a rehabilitation strategy with the caveat that they may change as more research is conducted.

Abstract Background Footwear has been shown to influence balance and is an important consideration in relation to the prevention of falls. However, it remains unclear as to what type of footwear is most beneficial for balance in older people: sturdy, supportive footwear, or minimalist footwear to maximise plantar sensory input. The objectives of this study were therefore to compare standing balance and walking stability in older women wearing these two footwear styles, and to investigate participants' perceptions in relation to comfort, ease of use and fit. Methods Older women (n = 20) aged 66 to 82 years (mean 73.4, SD 3.9) performed a series of laboratory tests of standing balance (eyes open and closed on floor and foam rubber mat, near tandem standing) and walking stability (treadmill, level and irregular surface) using a wearable sensor motion analysis system. Participants were tested wearing supportive footwear (incorporating design features to improve balance) and minimalist footwear. Perceptions of the footwear were documented using structured questionnaires. Results There were no statistically significant differences in balance performance between the supportive and minimalist footwear. Participants perceived the supportive footwear to be significantly more attractive to self and others, easier to put on and off but heavier compared to the minimalist footwear. Overall comfort was similar between the footwear conditions, although the supportive footwear was reported to be significantly more comfortable in the heel, arch height, heel cup, heel width and forefoot width regions. Eighteen participants (90%) reported that they felt more stable in the supportive footwear and 17 (85%) reported that they would consider wearing them to reduce their risk of falling. Conclusion Balance performance and walking stability were similar in supportive footwear designed to reduce the risk of falling and minimalist footwear, although participants preferred the supportive footwear in relation to aesthetics, ease of use, comfort and perceived stability. Prospective studies are now required to ascertain the longer‐term advantages and disadvantages of these footwear styles on comfort and stability in older people. Trial registration Australian New Zealand Clinical Trials Registry. ACTRN12622001257752p, 20/9/2022 (prospectively registered).

Abstract Background Podiatrists' earnings have an important influence on workforce dynamics. This includes the profession's ability to attract and retain workers so the population's healthcare needs can be met. This study aimed to describe financial characteristics of podiatry work and factors relating to a sense of financial security. Methods This was a cross sectional study using data from Victorian podiatrists who participated in Wave 1 of the Podiatrists in Australia: Investigating Graduate Employment (PAIGE) survey. Demographic and financial characteristics were described. The outcome measure, financial security, was collected through a self‐reported belief based on current financial situation and prospects, respondents' perception of having enough income to live on when they retire. Univariate logistic regression was used to determine associations with rural or metropolitan practice locations. Multiple ordered logistic regression was performed to explore associations between factors relating to financial security and retirement prospects. Results There were 286 Victorian podiatrist (18% of n = 1,585 Victorian podiatrists) respondents. Of these, 206 (72% of n = 286) identified as female, 169 (59% of 286) worked in the private sector and the mean (SD) age was 33.4 (9.5) years. The mean (SD) annual gross income was $79,194 ($45,651) AUD, and 243 (87% of 279) made regular superannuation contributions. Multiple ordered logistic regression analyses identified factors associated with podiatrists' perception of having adequate retirement income. These included being an owner/partner of their main workplace (adj OR = 2.70, 95% CI = 1.49–4.76), growing up in a rural location (adj OR = 2.27, 95% CI = 1.38–3.70), perceiving a moderate overall health rating (adj OR = 2.03 95% CI = 1.51–2.75), not having financial debt related to education and training (adj OR = 2.02, 95% CI = 1.24–3.32) and regular contributions to a superannuation scheme (adj OR = 4.76, 95% CI = 2.27–10.00). Conclusion This is the first known study to explore podiatrists' earnings and perceptions regarding financial security. Findings suggest modifiable ways to improve financial security of podiatrists including support and education about personal and business finances including debt management, understanding the importance of contributions to superannuation when self‐employed, and developing skills and supports for podiatrists to run their own businesses. This research is exploratory and is relevant for understanding the impact that income and financial security have on workforce dynamics.

Abstract Background Understanding the dynamics of the podiatry workforce is essential for the sustainability of the profession. This study aimed to describe the podiatry workforce characteristics and identify factors associated with rural practice location. Methods We used an exploratory descriptive design from data obtained during cross sectional study: Podiatrists in Australia: Investigating Graduate Employment through four online surveys (2017–2020). Demographic and workplace characteristics including career development were described. Univariate logistic regressions were used to determine associations with rural or metropolitan practice location. Results Data were included from 1, 135 podiatrists (21% of n = 5,429). There were 716 (69% of n = 1,042) females, 724 (65% of n = 1,118) worked in the public health service and 574 (51% of 1,129) were salaried employees. There were 706 (87% of n = 816) podiatrists with access to paid annual leave and 592 (72% of n = 816) to paid sick leave. There were 87 (32% of n = 276) podiatrists who reported 51–75% of workload involved Medicare bulk‐billed Chronic Disease Management plans, and 324 (74% of n = 436) not utilising telehealth. The majority of podiatrists (57% of n = 1,048) indicated their average consultation length was 21 ‐30 min, and patients typically waited

Abstract Objective The objectives of this study were to: (i) review and provide a narrative synthesis of three‐dimensional (3D) foot surface scanning methodological and statistical analysis protocols, and (ii) develop a set of recommendations for standardising the reporting of 3D foot scanning approaches. Methods A systematic search of the SCOPUS, ProQuest, and Web of Science databases were conducted to identify papers reporting 3D foot scanning protocols and analysis techniques. To be included, studies were required to be published in English, have more than ten participants, and involve the use of static 3D surface scans of the foot. Papers were excluded if they reported two‐dimensional footprints only, 3D scans that did not include the medial arch, dynamic scans, or derived foot data from a full body scan. Results The search yielded 78 relevant studies from 17 different countries. The available evidence showed a large variation in scanning protocols. The subcategories displaying the most variation included scanner specifications (model, type, accuracy, resolution, capture duration), scanning conditions (markers, weightbearing, number of scans), foot measurements and definitions used, and statistical analysis approaches. A 16‐item checklist was developed to improve the consistency of reporting of future 3D scanning studies. Conclusion 3D foot scanning methodological and statistical analysis protocol consistency and reporting has been lacking in the literature to date. Improved reporting of the included subcategories could assist in data pooling and facilitate collaboration between researchers. As a result, larger sample sizes and diversification of population groups could be obtained to vastly improve the quantification of foot shape and inform the development of orthotic and footwear interventions and products.

Abstract Background Maldistribution of podiatrists limits capacity to address the footcare needs of the population. Understanding factors that impact recruitment and retention of Australian podiatrists is a key solution. The primary aim of this study was to describe factors related to rural podiatry work, and overall professional retention amongst Australian podiatrists. Methods We used data collected from the most recent relevant response of a cohort of Australian podiatrists between 2017 and 2020 of four online surveys. Person and job role variables known to impact current work and retention were collected. Logistic regression models were used to determine factors associated with rural work and intent to leave direct patient care or the profession entirely. Results There were 1129 podiatrists (21% of 5429) who participated in at least one of the survey waves. Podiatrists who had a rural background (30%) were less likely to work in a metropolitan location (OR = 0.20, 95%CI = 0.11,0.37). Podiatrists who undertook a regional/rural placement during their undergraduate education (43%) were more likely to work in a metropolitan location (OR = 1.86, 95%CI = 1.38,2.51). Podiatrists who indicated they were planning to leave direct patient care within 5 years (n = 282, 26%), were less satisfied with working conditions (OR = 0.77, 95% CI = 0.66, 0.92), less satisfied with opportunities to use their abilities (OR = 0.83, 95% CI = 0.69, 0.99), perceived less personal accomplishment (OR = 0.94, 95% CI 0.86, 0.94) and less job satisfaction (OR = 0.92, 95% CI = 0.91, 0.98). Podiatrists who indicated that they were planning to leave podiatry work entirely within 5 years (n = 223, 21%), were less satisfied with opportunities to use their abilities (OR = 0.74, 95% CI = 0.62, 0.88), agreed they had a poor support network from other podiatrists (OR = 1.35, 95% CI = 1.13, 1.61), had less job satisfaction (OR = 0.89, 95% CI = 0.86, 0.94), and did not have access to paid annual leave (OR = 0.62, 95% CI = 0.38, 0.99). Conclusion Findings suggest ways to promote rural work, including selecting university students with rural backgrounds, and optimising the experience of rural placements which currently predict metropolitan practice. To retain podiatrists, it is important to ensure access to leave, professional support, and appropriate physical working conditions. Further research is required to understand why intention to leave is so high.

Abstract Background Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. Methods This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. Results Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64–100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5–0.6, 0.4 and

Abstract Foot posture and ankle joint dorsiflexion have long been proposed to be risk factors for plantar heel pain, however body mass may be a confounder when investigating these factors. The aim of this study was to determine if clinical measures of foot posture and ankle joint dorsiflexion differ in adults with and without plantar heel pain after accounting for body mass. This was a cross-sectional observational study that compared 50 participants with plantar heel pain to 25 control participants without plantar heel pain who were matched for age, sex and body mass index. Foot posture was assessed using the Foot Posture Index and the Arch Index. Ankle joint dorsiflexion was assessed with a weightbearing lunge test with the knee extended and with the knee flexed. No significant differences (P

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 Foot orthoses and corticosteroid injection are common interventions used for plantar heel pain, however few studies have investigated the variables that predict response to these interventions. Methods Baseline variables (age, weight, height, body mass index (BMI), sex, education, foot pain, foot function, fear-avoidance beliefs and feelings, foot posture, weightbearing ankle dorsiflexion, plantar fascia thickness, and treatment preference) from a randomised trial in which participants received either foot orthoses or corticosteroid injection were used to predict change in the Foot Health Status Questionnaire foot pain and foot function subscales, and first-step pain measured using a visual analogue scale. Multivariable linear regression models were generated for different dependent variables (i.e. foot pain, foot function and first-step pain), for each intervention (i.e. foot orthoses and corticosteroid injection), and at different timepoints (i.e. weeks 4 and 12). Results For foot orthoses at week 4, greater ankle dorsiflexion with the knee extended predicted reduction in foot pain (adjusted R 2 = 0.16, p = 0.034), and lower fear-avoidance beliefs and feelings predicted improvement in foot function (adjusted R 2 = 0.43, p = 0.001). At week 12, lower BMI predicted reduction in foot pain (adjusted R 2 = 0.33, p

Abstract Background Foot and ankle characteristics are associated with patellofemoral pain (PFP) and may also relate to patellofemoral osteoarthritis (PFOA). A greater understanding of these characteristics and PFOA, could help to identify effective targeted treatments. Objectives To determine whether foot and ankle characteristics are associated with knee symptoms and function in individuals with PFOA. Methods For this cross-sectional study we measured weightbearing ankle dorsiflexion range of motion, foot posture (via the Foot Posture Index [FPI]), and midfoot mobility (via the Foot Measurement Platform), and obtained patient-reported outcomes for knee symptoms and function (100 mm visual analogue scales, Anterior Knee Pain Scale [AKPS], Knee injury and Osteoarthritis Outcome Score, repeated single step-ups and double-leg sit-to-stand to knee pain onset). Pearson’s r with significance set at p

Abstract Background Patellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence-based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient-perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP. Methods This randomised, controlled, participant- and assessor-blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12–18 years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3 months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop-out rate. Secondary outcomes will evaluate knee-related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions, at 6 weeks and 3 months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between-group differences (with 95% confidence intervals) will be reported for secondary outcomes. Discussion Findings of this study will inform the feasibility of a full-scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full-scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population. Trial registration ACTRN12619000957190 .

Abstract Background Children and adolescents with Down syndrome have a distinctive foot shape (such as wide and flat feet) that often leads to difficulty with footwear fitting. 3-dimensional (3D) scanning can accurately measure the foot dimensions of individuals with Down syndrome, which may assist shoe fit. However, the reproducibility of measuring foot dimensions using 3D scans in children and adolescents with Down syndrome is unknown. The aim of this study was to determine the intra- and inter-rater reproducibility of measuring foot dimensions of children and adolescents with Down syndrome using 3D scanning. Methods 3D foot scans of 30 participants with Down syndrome aged 5 to 17 years were obtained using the FotoScan 3D scanner. Foot dimensions assessed were foot length, ball of foot length, outside ball of foot length, diagonal foot width, horizontal foot width, heel width, ball girth, instep girth, first and fifth toe height, and instep height. Additionally, the Wesjflog Index and forefoot shape were determined. Measurements were completed by two raters independently on two separate occasions, 2 weeks apart. Intra- and inter-rater reliability were assessed using intra-class coefficients (ICCs) and Gwet’s AC1 statistics with 95% confidence intervals. Agreement was determined by calculating limits of agreement (LOA) and percentage agreement. Results Eighteen participants were female and 12 were male (mean age 10.6 [3.9] years). Intra-rater reproducibility (ICCs ranged from 0.74 to 0.99, 95% LOA from − 13.7 mm to 16.3 mm) and inter-rater reproducibility (ICCs ranging from 0.73 to 0.99, 95% LOA from − 18.8 mm to 12.7 mm) was good to excellent, although some measurements (ball of foot length, outside ball of foot length, heel width and girth measurements) displayed wider LOAs indicating relatively poorer agreement. Forefoot shape displayed substantial to almost perfect reliability (Gwet’s AC1 0.68 to 0.85) and percentage agreement ranged from 73 to 87%, indicating acceptable agreement. Conclusions The measurement of specific foot dimensions of children and adolescents with Down syndrome using 3D scans is reproducible. Findings of this study may be used to support future research measuring specific foot dimensions of children and adolescents with Down syndrome using 3D foot scans.

Abstract Background Osteoarthritis of the first metatarsophalangeal joint (1st MTP joint OA) is a common and disabling condition that results in pain and limited joint range of motion. There is inconsistent evidence regarding the relationship between clinical measurement of 1st MTP joint maximum dorsiflexion and dynamic function of the joint during level walking. Therefore, the aim of this study was to examine the association between passive non-weightbearing (NWB) 1st MTP joint maximum dorsiflexion and sagittal plane kinematics in individuals with radiographically confirmed 1st MTP joint OA. Methods Forty-eight individuals with radiographically confirmed 1st MTP joint OA (24 males and 24 females; mean age 57.8 years, standard deviation 10.5) underwent clinical measurement of passive NWB 1st MTP joint maximum dorsiflexion and gait analysis during level walking using a 10-camera infrared Vicon motion analysis system. Sagittal plane kinematics of the 1st MTP, ankle, knee, and hip joints were calculated. Associations between passive NWB 1st MTP joint maximum dorsiflexion and kinematic variables were explored using Pearson’s r correlation coefficients. Results Passive NWB 1st MTP joint maximum dorsiflexion was significantly associated with maximum 1st MTPJ dorsiflexion (r = 0.486, p

Abstract Background Forefoot pads such as metatarsal domes are commonly used in clinical practice for the treatment of pressure-related forefoot pain, however evidence for their effects is inconsistent. This study aimed to evaluate the effects on plantar pressures of metatarsal domes in different positions relative to the metatarsal heads. Methods Participants in this study included 36 community-dwelling adults aged 65 or older with a history of forefoot pain. Standardised footwear was used and plantar pressures were measured using the pedar®-X in-shoe plantar pressure measurement system. Peak pressure, maximum force and contact area were analysed using an anatomically-based masking protocol that included three forefoot mask sub-areas (proximal to, beneath, and distal to the metatarsal heads). Data were collected for two different types of prefabricated metatarsal domes of different densities (Emsold metatarsal dome and Langer PPT metatarsal pad) in three different positions relative to the metatarsal heads. Seven conditions were tested in this study: (i) control (no pad) condition, (ii) Emsold metatarsal dome positioned 5 mm proximal to the metatarsal heads, (iii) Emsold metatarsal dome positioned in-line with the metatarsal heads, (iv), Emsold metatarsal dome positioned 5 mm distal to the metatarsal heads, (v) Langer PPT metatarsal pad positioned 5 mm proximal to the metatarsal heads, (vi) Langer PPT metatarsal pad positioned in-line with the metatarsal heads, and (vii) Langer PPT metatarsal pad positioned 5 mm distal to the metatarsal heads. Results When analysed with the mask that was distal to the metatarsal heads, where the plantar pressure readings were at their highest, all metatarsal dome conditions led to significant reductions in plantar pressure at the forefoot compared to the control (no pad) condition (F3.9, 135.6 = 8.125, p

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

Abstract Background Fear of falling is multifactorial in etiology and is associated with falls. It has been demonstrated that foot problems increase the risk of falls in older people. Therefore, the objective of this study was to investigate the associations of foot and ankle characteristics with fear of falling and mobility in community‐dwelling older people. Method One hundred and eighty‐seven community‐dwelling older adults (106 females) aged 62–90 years (mean 70.5 ± 5.2) from Isfahan, Iran, were recruited. Foot and ankle characteristics (including foot posture, range of motion, muscle strength, deformity, tactile sensation, pain and dynamic function), fear of falling (Fall Efficacy Scale International) and mobility (Timed Up and Go Test) were measured. Two multivariate linear regression analyses identified variables independently associated with fear of falling and mobility. Results Linear regression analysis revealed that less ankle plantarflexor muscle strength, greater pressure‐time integral, foot pain, and reduced tactile sensitivity of the ankle were significantly and independently associated with increased fear of falling. The total variance explained by the model was 59%. Less ankle plantarflexor muscle strength, greater pressure‐time integral, and slower centre of pressure velocity were significantly and independently associated with poorer mobility. The total variance explained by the model was 48%. Conclusion Several foot and ankle characteristics are associated with fear of falling and mobility in older people. Targeting these modifiable risk factors may play a role in reducing fear of falling and enhancing mobility performance in this population.

Abstract Background Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aims to determine the feasibility of conducting a fully‐powered parallel group randomised trial to evaluate the effectiveness of a multifaceted non‐surgical intervention for reducing pain associated with hallux valgus. Methods Twenty‐eight community‐dwelling women with painful hallux valgus will be randomised to receive either a multifaceted, non‐surgical intervention (footwear, foot orthoses, foot exercises, advice, and self‐management) or advice and self‐management alone. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks. The primary outcome is feasibility, which will be evaluated according to demand, acceptability, adherence, adverse events, and retention rate. Limited efficacy testing will be conducted on secondary outcome measures including foot pain (the Manchester‐Oxford Foot Questionnaire), foot muscle strength (hand‐held dynamometry), general health‐related quality of life (the Short Form‐12), use of cointerventions, and participants' perception of overall treatment effect. Biomechanical testing will be conducted at baseline to evaluate the immediate effects of the footwear/orthotic intervention on pressure beneath the foot and on the medial aspect of the first metatarsophalangeal joint and hallux. Discussion This study will determine the feasibility of conducting a fully‐powered randomised trial of footwear, foot orthoses, foot exercises, advice and self‐management for relieving pain associated with hallux valgus and provide insights into potential mechanisms of effectiveness. Trial registration Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).

Abstract Background Foot disorders may limit independence and reduce quality of life for older adults. Obesity is a risk factor for foot conditions; both mechanical load and metabolic effects may contribute to these conditions. This study determined cross‐sectional associations between inflammatory markers and foot disorders. Methods Participants were drawn from the Framingham Foot Study (2002–2008). C‐reactive protein (CRP), interleukin‐6 (IL‐6), and tumor necrosis factor alpha (TNF‐α) were each examined for associations with foot pain, forefoot pain, hindfoot pain, hallux valgus, hallux rigidus, and toe deformities (claw, hammer, or overlapping toes). Unadjusted and adjusted (age, body mass index, physical activity, smoking status) sex‐specific logistic regression was performed. Results Of 909 participants, 54% were women (mean age 65 ± 9 years), 20% had foot pain, 29% had hallux valgus, 3% had hallux rigidus, and 27% had toe deformities. In unadjusted models, higher CRP (OR [95% CI] = 1.5 [1.1, 2.0]) and IL‐6 (OR [95% CI] = 1.8 [1.2, 2.6]) were associated with foot pain among men; higher CRP was associated with foot pain (OR [95% CI] = 1.3 [1.0, 1.5]) among women. Higher CRP (OR [95% CI] = 1.9 [1.1, 3.2]) and IL‐6 (OR [95% CI] = 2.4 [1.2, 4.7]) were associated with forefoot pain in men. Higher CRP was associated with hindfoot pain ([95% CI] = 1.8 [1.2, 2.6]) in women. After adjustment, CRP ([95% CI] = 1.5 [1.1, 2.0]) and IL‐6 ([95% CI] = 1.8 [1.2, 2.6]) remained associated with foot pain in men, and IL‐6 with forefoot pain ([95% CI] = 2.9 [1.4, 6.1]) in men. No associations with structural foot disorders were observed. Conclusions Inflammation may impact foot pain. Future work assessing whether inflammation is part of the mechanism linking obesity to foot pain may identify areas for intervention and prevention.

Abstract Background Patellofemoral pain (PFP) affects one‐quarter of adolescents, yet there are few evidence‐informed recommendations to treat PFP in this population. HAPPi Kneecaps! is a randomised, controlled, participant‐ and assessor‐blind, parallel‐group feasibility trial of shoe inserts for adolescents with PFP. The aim of this qualitative study was to explore adolescents' perspectives of participating in HAPPi Kneecaps!. Methods All 36 adolescents with PFP from the HAPPi Kneecaps! study were invited to participate in semi‐structured interviews. We used a descriptive qualitative methodology underpinned by a relativist framework to investigate adolescents' perspectives on participating in the trial. Inductive thematic analysis was used to examine patterns regarding how each adolescent experienced the HAPPi Kneecaps! study within their social, cultural, and historical contexts. Results 14 out of 36 HAPPi Kneecaps! participants provided consent and participated in interviews (12 females; mean [SD] age 14.9 [2.4] years). Overall, most adolescents responded positively when discussing their experience, such as improvements in their knee pain and satisfaction with how the study was run. Major themes that were generated from the analysis and feedback were: (1) shoe inserts require little effort to use; (2) perceptions of the program were generally positive; (3) participation in the trial could be made easier; (4) warm weather matters; and (5) life happens. Conclusion Adolescents with PFP who participated in the HAPPi Kneecaps! study found that shoe inserts were easy to wear. Most adolescents experienced an improvement in their symptoms and enhanced participation in sport and exercise. Adolescents with PFP prefer an option for warmer climates (e.g. flip flops or sandals), access to online logbooks, and clinicians who are easily accessible. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000957190. Date registered: 8/07/2019.

Abstract Background Corticosteroid injection is frequently used for plantar heel pain (plantar fasciitis), although there is limited high-quality evidence to support this treatment. Therefore, this study reviewed randomised trials to estimate the effectiveness of corticosteroid injection for plantar heel pain. Methods A systematic review and meta-analysis of randomised trials that compared corticosteroid injection to any comparator. Primary outcomes were pain and function, categorised as short (0 to 6 weeks), medium (7 to 12 weeks) or longer term (13 to 52 weeks). Results A total of 47 trials (2989 participants) were included. For reducing pain in the short term, corticosteroid injection was more effective than autologous blood injection (SMD -0.56; 95% CI, − 0.86 to − 0.26) and foot orthoses (SMD -0.91; 95% CI, − 1.69 to − 0.13). There were no significant findings in the medium term. In the longer term, corticosteroid injection was less effective than dry needling (SMD 1.45; 95% CI, 0.70 to 2.19) and platelet-rich plasma injection (SMD 0.61; 95% CI, 0.16 to 1.06). Notably, corticosteroid injection was found to have similar effectiveness to placebo injection for reducing pain in the short (SMD -0.98; 95% CI, − 2.06, 0.11) and medium terms (SMD -0.86; 95% CI, − 1.90 to 0.19). For improving function, corticosteroid injection was more effective than physical therapy in the short term (SMD -0.69; 95% CI, − 1.31 to − 0.07). When trials considered to have high risk of bias were excluded, there were no significant findings. Conclusions Based on the findings of this review, corticosteroid injection is more effective than some comparators for the reduction of pain and the improvement of function in people with plantar heel pain. However, corticosteroid injection is not more effective than placebo injection for reducing pain or improving function. Further trials that are of low risk of bias will strengthen this evidence. Registration PROSPERO registration number CRD42016053216.

Abstract Background Foot orthoses have the potential to be an efficacious treatment for patellofemoral osteoarthritis (PFOA) but have not been evaluated in clinical trials in this population. This study aimed to determine the: (i) feasibility of conducting a randomised controlled trial (RCT) investigating the efficacy of foot orthoses in individuals with PFOA; and (ii) effects of foot orthoses versus flat shoe inserts on pain, function, and knee-related quality of life (QOL). Methods This 6-week, single-blinded pilot RCT randomly allocated participants with PFOA to receive foot orthoses or flat inserts. The primary outcome of feasibility was determined via the following parameters: one participant recruited per week, 20% (35 h/week) adherence to the intervention, 50% log book completion rate, and 20% (37.2 [9.8] hours/week) adherence to the intervention, 69.2% (18/26) log-book completion, and 3.8% (1/26) drop-outs. The most common adverse events were arch irritation and shoe fit issues, which were more common in the foot orthoses group (67.9% versus 32.1%). There was a trend for the foot orthoses group to report larger improvements in average and maximum pain than the flat insert group, with the mean difference for maximum knee pain severity (21.9 mm, 95% CI − 2.1 to 46.0) exceeding the minimal clinically important difference (15 mm). The estimated sample size for a full-scale RCT is 160 participants. Suggestions to improve study design include a greater number of face-to-face follow-up appointments, a larger variety of foot orthoses to reduce rates of adverse events, and increasing follow-up time to determine long-term efficacy. Conclusion This study supports the feasibility of a full-scale RCT to determine the efficacy of foot orthoses versus flat inserts in individuals with PFOA. Trial registration The trial protocol was retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number: 12616001287426).

Abstract Background The objectives of this study were to estimate the population prevalence and distribution of plantar heel pain in mid-to-older age groups, examine associations with selected health status and lifestyle factors, and report the frequency of healthcare use. Methods Adults aged ≥50 years registered with four general practices were mailed a health survey (n = 5109 responders). Plantar heel pain in the last month was defined by self-reported shading on a foot manikin, and was defined as disabling if at least one of the function items of the Manchester Foot Pain and Disability Index were also reported. Population prevalence estimates and associations between plantar heel pain and demographic characteristics, health status measures and lifestyle factors were estimated using multiple imputation and weighted logistic regression. Healthcare professional consultation was summarised as the 12-month period prevalence of foot pain-related consultation. Results The population prevalence of plantar heel pain was 9.6% (95% CI: 8.8, 10.5) and 7.9% (7.1, 8.7) for disabling plantar heel pain. Occurrence was slightly higher in females, comparable across age-groups, and significantly higher in those with intermediate/routine and manual occupations. Plantar heel pain was associated with physical and mental impairment, more anxiety and depression, being overweight, a low previous use of high-heeled footwear, and lower levels of physical activity and participation. The 12-month period prevalence of foot pain-related consultation with a general practitioner, physiotherapist or podiatrist/chiropodist was 43.0, 15.1 and 32.8%, respectively. Conclusions Plantar heel pain is a common, disabling symptom among adults aged 50 years and over. Observed patterns of association indicate that in addition to focused foot-specific management, primary care interventions should also target more general physical and psychological factors that could potentially act as barriers to treatment adherence and recovery.

Abstract Background Mid-portion Achilles tendinopathy is a common musculoskeletal condition characterised by degeneration of the Achilles tendon, which causes pain and disability. Multiple non-surgical treatments have been advocated for this condition including calf muscle eccentric exercise and in-shoe heel lifts. Although adherence is challenging, there is evidence to suggest that calf muscle eccentric exercise is effective in decreasing pain and improving function in people with Achilles tendinopathy. Heel lifts reduce ankle joint dorsiflexion and Achilles tendon strain, however their efficacy in the management of Achilles tendinopathy is unclear. This article describes the design of a parallel-group randomised trial comparing the efficacy of heel lifts to calf muscle eccentric exercise for Achilles tendinopathy. Methods Ninety-two participants with Achilles tendinopathy will be randomised to one of two groups: (i) a heel lift group that will receive pre-fabricated 12 mm in-shoe heel lifts (Clearly Adjustable®), or (ii) an exercise group that will be advised to carry out a calf muscle eccentric exercise program (twice a day, 7 days a week, for 12 weeks). Outcome measures will be obtained at baseline, 2, 6 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment – Achilles (VISA–A) questionnaire. Secondary outcome measures will include thickness and integrity of the Achilles tendon (using ultrasound tissue characterisation [UTC]), participant perception of treatment effect on pain and function (using the 7-point Patient Global Impression of Change scale), severity of pain at the Achilles tendon (using a 100 mm visual analogue scale) in the previous week, health status (using the EuroQol-5D-5L™ questionnaire), physical activity levels (using the 7-day Recall Physical Activity Questionnaire) and calf muscle function (using the standing heel rise test). Data will be analysed using the intention to treat principle. Discussion The HEALTHY trial (Heel lifts versus calf muscle eccentric Exercise for AchiLles TendinopatHY) is the first randomised trial to compare the efficacy of heel lifts to calf muscle eccentric exercise in reducing pain and improving function in people with Achilles tendinopathy. A pragmatically designed trial was developed to ensure that if the interventions are found to be effective, the findings can be readily implemented in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12617001225303. Registered on August 22nd, 2017.

Abstract Background Gout frequently affects the foot yet relatively little is known about the effects of gout on foot structure, pain and functional ability. This study aimed to describe the impact of gout in a UK primary care population. Methods A cross-sectional study was nested within an observational cohort study of adults aged ≥50 years with foot pain. Participants with gout were identified through their primary care medical records and each matched on age (±2 years) and gender to four participants without gout. Differences in person-level variables (SF-12 Physical Component Score, Manchester Foot Pain and Disability Index and Short Physical Performance Battery) between gout and non-gout participants were determined using regression models. Differences in foot-level variables (pain regions, skin lesions, deformities, foot posture, and non-weightbearing range of motion) were determined using multi-level regression models. All models were adjusted for body mass index. Means and probabilities with 95% confidence intervals were calculated. Results Twenty-six participants with gout were compared to 102 participants without gout (77% male; mean age 66 years, standard deviation 11). Subtalar joint inversion and eversion and 1st metatarsophalangeal joint (MTPJ) dorsiflexion range of motion were significantly lower in the gout participants compared to the non-gout participants. Gout participants were more likely to have mallet toes and less likely to have claw toes compared to non-gout participants. There were no statistically significant differences in person-level variables, foot posture, ankle dorsiflexion range of motion, hallux valgus, pain regions, or skin lesions. Conclusions Non-weightbearing range of motion at the subtalar joint and 1st MTPJ was reduced in people with gout. Patients with gout who present with chronic foot problems should therefore undergo appropriate clinical assessment of foot structure.

Abstract Background On the 19th of January, 2020, the Chief Medical Officer of Australia issued a statement about a novel coronavirus, or SARS‐CoV‐2. Since this date, there have been variable jurisdictional responses, including lockdowns, and restrictions on podiatry practice. This study aimed to describe impacts of the SARS‐CoV‐2 pandemic on the podiatry profession in Australia. Methods This was a cross sectional study of Australian podiatrists using demographic data collected between 2017 and 2020, and pandemic‐related question responses collected between 30th March and 31st August, 2020. Data were collected online and participants described their work settings, patient funding types, business decisions and impacts, and information sources used to guide practice decisions during this time‐period. Inductive thematic analysis was used to analyse open‐ended questions about their practice impact of SARS‐CoV‐2. Results There were 732 survey responses, with 465 Australian podiatrists or podiatric surgeons providing responses describing pandemic impact. From these responses, 223 (49% of 453) podiatrists reported no supply issues, or having adequate supplies for the foreseeable future with personal protective equipment (PPE) or consumables to support effective infection prevention and control. The most frequent responses about employment, or hours of work, impact were reported in the various categories of “business as usual” (n = 312, 67%). Participants described most frequently using the local state and territory Department of Health websites (n = 347, 75%), and the Australian Podiatry Association (n = 334, 72%) to make decisions about their business. Overarching themes which resounded through open‐ended comments was that working through the pandemic was likened to a marathon, and not a sprint. Themes were: (i) commitment to do this, (ii) it's all in the plan, but not everything goes to plan, (iii) my support team must be part of getting through it, (iv) road blocks happen, and (v) nothing is easy, what's next? Conclusion Podiatrists in Australia reported variable pandemic impact on their business decisions, PPE stores, and their valued sources of information. Podiatrists also described their “marathon” journey through the pandemic to date, with quotes describing their challenges and highlights. Describing these experiences should provide key learnings for future workforce challenges, should further restrictions come into place.

Abstract Background Patellofemoral pain (PFP) affects one‐third of adolescents and can persist into adulthood, negatively impacting health and quality of life. Foot orthoses are a recommended treatment for adults with PFP, but have not been evaluated in adolescents. The primary objective was to determine the feasibility of conducting a full‐scale randomised controlled trial (RCT) evaluating effects of contoured, prefabricated foot orthoses on knee pain severity and patient‐perceived global change, compared to flat insoles. The secondary objective was to describe outcomes on a range of patient‐reported outcome measures. Methods We recruited adolescents aged 12–18 years with PFP of ≥2 months duration into a double‐blind, randomised, parallel‐group feasibility trial. Participants were randomised to receive prefabricated contoured foot orthoses or flat shoe insoles, and followed for 3 months. Participants and outcome assessors were blinded to group allocation. Primary outcomes were feasibility of a full‐scale RCT (number of eligible/enrolled volunteers; recruitment rate; adherence with the intervention and logbook completion; adverse effects; success of blinding; drop‐out rate), and credibility and expectancy of interventions. Secondary outcomes were patient‐reported measures of pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co‐interventions. Results 36 out of 279 (12.9%) volunteers (27 female, mean (SD) age 15 (2) years, body mass 60 (13) kg) were eligible and enrolled, at a recruitment rate of 1.2 participants/week. 17 participants were randomised to receive foot orthoses, and 19 to flat insoles. 15 participants returned logbooks; 7/15 (47%) adhered to the intervention. No serious adverse events were reported. 28% (10/36, 4 pandemic‐related) of participants dropped out before 3 months. Blinding was successful. Both groups found the inserts to be credible. Conclusions Based on a priori criteria for feasibility, findings suggest that a full‐scale RCT comparing contoured foot orthoses to flat insoles in adolescents with PFP would not be feasible using the current protocol. Prior to conducting a full‐scale RCT, feasibility issues should be addressed, with protocol modifications to facilitate participant retention, logbook completion and shoe insert wear. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000957190. Date registered: 8/07/2019.

Abstract Objective To provide a narrative synthesis of the research literature pertaining to footwear comfort, including definitions, measurement scales, footwear design features, and physiological and psychological factors. Methods A systematic search was conducted which yielded 101 manuscripts. The most relevant manuscripts were selected based on the predetermined subheadings of the review (definitions, measurement scales, footwear design features, and physiological and psychological factors). A narrative synthesis of the findings of the included studies was undertaken. Results The available evidence is highly fragmented and incorporates a wide range of study designs, participants, and assessment approaches, making it challenging to draw strong conclusions or implications for clinical practice. However, it can be broadly concluded that (i) simple visual analog scales may provide a reliable overall assessment of comfort, (ii) well‐fitted, lightweight shoes with soft midsoles and curved rocker‐soles are generally perceived to be most comfortable, and (iii) the influence of sole flexibility, shoe microclimate and insoles is less clear and likely to be more specific to the population, setting and task being performed. Conclusion Footwear comfort is a complex and multifaceted concept that is influenced not only by structural and functional aspects of shoe design, but also task requirements and anatomical and physiological differences between individuals. Further research is required to delineate the contribution of specific shoe features more clearly, and to better understand the interaction between footwear features and individual physiological attributes.

Abstract Journal of Foot and Ankle Research (JFAR) was launched in July 2008 as the official research publication of the Society of Chiropodists and Podiatrists (UK) and the Australasian Podiatry Council, replacing both the British Journal of Podiatry and the Australasian Journal of Podiatric Medicine. This editorial celebrates the 10 year anniversary of the journal.

Abstract Background Correct footwear fitting is acknowledged as being vitally important, as incorrectly fitted footwear has been linked to foot pathology. The aim of this narrative review was to determine the prevalence of incorrectly fitted footwear and to examine the association between incorrectly fitted footwear, foot pain and foot disorders. Methods A database search of Ovid MEDLINE and CINAHL yielded 1,681 citations for title and abstract review. Eighteen articles were included. Findings were summarised under the categories of (i) children, (ii) adults, (ii) older people, (iii) people with diabetes and (iii) occupation- or activity-specific footwear. Differences in footwear fitting between sexes were also explored. Results Between 63 and 72% of participants were wearing shoes that did not accommodate either width or length dimensions of their feet. There was also evidence that incorrect footwear fitting was associated with foot pain and foot disorders such as lesser toe deformity, corns and calluses. Specific participant groups, such as children with Down syndrome and older people and people with diabetes were more likely to wear shoes that were too narrow (between 46 and 81%). Conclusion A large proportion of the population wear incorrectly sized footwear, which is associated with foot pain and foot disorders. Greater emphasis should be placed on both footwear fitting education and the provision of an appropriately large selection of shoes that can accommodate the variation in foot morphology among the population, particularly in relation to foot width.

Abstract Background The area beneath the metatarsal heads is a common location of foot pain, which is often associated with high plantar pressures. Current plantar pressure assessment protocols focus mainly on the gross area of the forefoot with minimal attention paid to specific areas such as the metatarsal heads. The aim of this study was to develop and assess a new anatomically-based masking protocol that is clinically relevant to measure forefoot plantar pressure during shod conditions based on the anatomical positions of the metatarsal heads. Methods Initially, we developed a masking protocol to measure forefoot plantar pressure during shod conditions based on the anatomical positions of the metatarsal heads. This new masking protocol divided the forefoot into three sub-areas (proximal, beneath, and distal to the metatarsal heads) as determined by the position of each metatarsal head. Following development of the new masking protocol, we compared the new protocol against a traditional protocol, which defines the forefoot as between 51 and 81% of the foot length. To compare the two masking protocols, we tested two experimental conditions: (i) a control condition (i.e. no metatarsal pad), and (ii) a metatarsal pad condition. We then compared plantar pressure differences between the two experimental conditions for the two masking protocols. Participants for this component of the study included 36 community dwelling older adults (mean age 75.6 years ±5.4) with a history of forefoot pain. Forefoot plantar pressure data were measured while walking using the pedar®-X in-shoe system. Peak pressure, maximum force and contact area at the time of peak pressure were determined and results were compared between the two masking protocols. Results The traditional masking protocol showed that the metatarsal pad significantly decreased peak pressure and increased contact area in the forefoot area (i.e. within the entire mask area), but maximum force was not significantly different between the two conditions. In contrast, the newly developed anatomically-based masking protocol indicated that the metatarsal pad decreased peak plantar pressures distal to and beneath the metatarsal heads by increasing force and contact area proximal to the metatarsal heads. Conclusions An anatomically-based masking protocol that is clinically relevant was developed to assess forefoot plantar pressure during shod conditions based on the anatomical positions of metatarsal heads. We propose that the new forefoot masking protocol will provide greater interpretability of forefoot plantar pressure data, which will aid clinicians and researchers for diagnostic, prognostic and therapeutic purposes.

Abstract Background Age-related changes in midfoot mobility have the potential to influence success with foot orthoses intervention in people with patellofemoral pain (PFP). The aim of this study was to determine whether older people with PFP demonstrate less foot mobility than younger adults with PFP. Methods One hundred ninety four participants (113 (58%) women, age 32 ± 7 years, BMI 25 ± 4.9 kg/m2) with PFP (≥ 6 weeks duration) were included, with foot mobility quantified using reliable and valid methods. K-means cluster analysis classified participants into three homogenous groups based on age. After cluster formation, univariate analyses of co-variance (covariates: sex, weight) were used to compare midfoot height mobility, midfoot width mobility, and foot mobility magnitude between age groups (significance level 0.05). Results Cluster analysis revealed three distinct age groups: 18–29 years (n = 70); 30–39 years (n = 101); and 40–50 years (n = 23). There was a significant main effect for age for midfoot height mobility (p 0.05). Conclusion Individuals with PFP aged 40–50 years have less foot mobility than younger adults with PFP. These findings may have implications for evaluation and treatment of older individuals with PFP.

Abstract Background The aim of this study was to compare centre of pressure (COP) characteristics between healthy adults with normal, planus or cavus feet who were allocated to groups based on reliable foot posture measurement techniques. Methods Ninety-two healthy adult participants (aged 18 to 45) were recruited and classified as either normal (n = 35), pes planus (n = 31) or pes cavus (n = 26) based on Foot Posture Index, Arch Index and normalised navicular height truncated measurements. Barefoot walking trials were conducted using an emed®-x 400 plantar pressure system (Novel GmbH, Munich, Germany). Average, maximum, minimum and range (difference between maximum and minimum) values were calculated for COP velocity and lateral-medial force index during loading response, midstance, terminal stance and pre-swing phases of stance. The COP excursion index was also calculated. One-way analyses of variance were used to compare the three foot posture groups. Results The cavus foot exhibited the slowest average and minimum COP velocity during terminal stance, but this pattern was reversed during pre-swing, when the cavus foot exhibited the fastest maximum COP velocity. The planus foot exhibited the smallest lateral medial force index range during terminal stance. There were no differences between the groups for COP excursion index. Conclusion These findings indicate that there are differences in COP characteristics between foot postures, which may represent different mechanisms for generating force to facilitate forward progression of the body during the propulsive phases of gait.

Abstract Background The aim of this paper was to create an updated Australian guideline on footwear for people with diabetes. Methods We reviewed new footwear publications, (inter)national guidelines, and consensus expert opinion alongside the 2013 Australian footwear guideline to formulate updated recommendations. Result We recommend health professionals managing people with diabetes should: (1) Advise people with diabetes to wear footwear that fits, protects and accommodates the shape of their feet. (2) Advise people with diabetes to always wear socks within their footwear, in order to reduce shear and friction. (3) Educate people with diabetes, their relatives and caregivers on the importance of wearing appropriate footwear to prevent foot ulceration. (4) Instruct people with diabetes at intermediate- or high-risk of foot ulceration to obtain footwear from an appropriately trained professional to ensure it fits, protects and accommodates the shape of their feet. (5) Motivate people with diabetes at intermediate- or high-risk of foot ulceration to wear their footwear at all times, both indoors and outdoors. (6) Motivate people with diabetes at intermediate- or high-risk of foot ulceration (or their relatives and caregivers) to check their footwear, each time before wearing, to ensure that there are no foreign objects in, or penetrating, the footwear; and check their feet, each time their footwear is removed, to ensure there are no signs of abnormal pressure, trauma or ulceration. (7) For people with a foot deformity or pre-ulcerative lesion, consider prescribing medical grade footwear, which may include custom-made in-shoe orthoses or insoles. (8) For people with a healed plantar foot ulcer, prescribe medical grade footwear with custom-made in-shoe orthoses or insoles with a demonstrated plantar pressure relieving effect at high-risk areas. (9) Review prescribed footwear every three months to ensure it still fits adequately, protects, and supports the foot. (10) For people with a plantar diabetic foot ulcer, footwear is not specifically recommended for treatment; prescribe appropriate offloading devices to heal these ulcers. Conclusions This guideline contains 10 key recommendations to guide health professionals in selecting the most appropriate footwear to meet the specific foot risk needs of an individual with diabetes.

Abstract Background Footwear has the potential to influence balance in either a detrimental or beneficial manner, and is therefore an important consideration in relation to falls prevention. The objective of this study was to evaluate balance ability and gait patterns in older women while wearing prototype footwear and insoles designed to improve balance. Methods Older women (n = 30) aged 65 – 83 years (mean 74.4, SD 5.6) performed a series of laboratory tests of balance ability (postural sway on a foam rubber mat, limits of stability and tandem walking, measured with the Neurocom® Balance Master) and gait patterns (walking speed, cadence, step length and step width at preferred speed, measured with the GAITRite® walkway) while wearing (i) flexible footwear (Dunlop Volley™), (ii) their own footwear, and (iii) prototype footwear and insoles designed to improve dynamic balance. Perceptions of the footwear were also documented using a structured questionnaire. Results There was no difference in postural sway, limits of stability or gait patterns between the footwear conditions. However, when performing the tandem walking test, there was a significant reduction in step width and end sway when wearing the prototype footwear compared to both the flexible footwear and participants’ own footwear. Participants perceived their own footwear to be more attractive, comfortable, well-fitted and easier to put on and off compared to the prototype footwear. Despite this, most participants (n = 18, 60%) reported that they would consider wearing the prototype footwear to reduce their risk of falling. Conclusion The prototype footwear and insoles used in this study improve balance when performing a tandem walk test, as evidenced by a narrower step width and decreased sway at completion of the task. However, further development of the design is required to make the footwear acceptable to older women from the perspective of aesthetics and comfort. Trial registration Australian New Zealand Clinical Trials Registry. ACTRN12617001128381 , 01/08/2017 (retrospectively registered).

Abstract Background Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Methods Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. Results 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses ‘all or most of the time’. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. Conclusions A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised controlled trial of the intervention. Although not powered to determine effectiveness, these preliminary data provide justification for a larger trial, incorporating a full process evaluation, to determine whether this intervention can significantly reduce falls in this high-risk population. Trial registration ClinicalTrials.gov identifier: NCT02178527 ; Date of registration: 17 June 2014.

Abstract Background There is a well-recognised relationship between body weight, plantar pressures and foot pain, but the temporal association between these factors is unknown. The aim of this study was to investigate the relationships between increasing weight, plantar pressures and foot pain over a two-year period. Methods Fifty-one participants (33 women and 18 men) completed the two-year longitudinal cohort study. The sample had a mean (standard deviation (SD)) age of 52.6 (8.5) years. At baseline and follow-up, participants completed the Manchester Foot Pain and Disability Index questionnaire, and underwent anthropometric measures, including body weight, body mass index, and dynamic plantar pressures. Within-group analyses examined differences in body weight, foot pain and plantar pressures between baseline and follow up, and multivariate regression analysis examined associations between change in body weight, foot pain and plantar pressure. Path analysis assessed the total impact of both the direct and indirect effects of change in body weight on plantar pressure and pain variables. Results Mean (SD) body weight increased from 80.3 (19.3), to 82.3 (20.6) kg, p = 0.016 from baseline to follow up. The change in body weight ranged from −16.1 to 12.7 kg. The heel was the only site to exhibit increased peak plantar pressures between baseline and follow up. After adjustment for age, gender and change in contact time (where appropriate), there were significant associations between: (i) change in body weight and changes in midfoot plantar pressure (B = 4.648, p = 0.038) and functional limitation (B = 0.409, p = 0.010), (ii) plantar pressure change in the heel and both functional limitation (B = 4.054, p = 0.013) and pain intensity (B = 1.831, p = 0.006), (iii) plantar pressure change in the midfoot and both functional limitation (B = 4.505, p = 0.018) and pain intensity (B = 1.913, p = 0.015). Path analysis indicated that the effect of increasing body weight on foot-related functional limitation and foot pain intensity may be mediated by increased plantar pressure in the midfoot. Conclusions These findings suggest that as body weight and plantar pressure increase, foot pain increases, and that the midfoot may be the most vulnerable site for pressure-related pain.

Abstract Background Foot orthoses are widely used in the prevention and treatment of foot disorders. The aim of this study was to describe characteristics of custom-made foot orthosis prescriptions from a Australian podiatric orthotic laboratory. Methods One thousand consecutive foot orthosis prescription forms were obtained from a commercial prescription foot orthosis laboratory located in Melbourne, Victoria, Australia (Footwork Podiatric Laboratory). Each item from the prescription form was documented in relation to orthosis type, cast correction, arch fill technique, cast modifications, shell material, shell modifications and cover material. Cluster analysis and discriminant function analysis were applied to identify patterns in the prescription data. Results Prescriptions were obtained from 178 clinical practices across Australia and Hong Kong, with patients ranging in age from 5 to 92 years. Three broad categories (‘clusters’) were observed that were indicative of increasing ‘control’ of rearfoot pronation. A combination of five variables (rearfoot cast correction, cover shape, orthosis type, forefoot cast correction and plantar fascial accommodation) was able to identify these clusters with an accuracy of 70%. Significant differences between clusters were observed in relation to age and sex of the patient and the geographic location of the prescribing clinician. Conclusion Foot orthosis prescriptions are complex, but can be broadly classified into three categories. Selection of these prescription subtypes appears to be influenced by both patient factors (age and sex) and clinician factors (clinic location).

Abstract Background Osteoarthritis of the first metatarsophalangeal joint (1st MTPJ OA) is a common and disabling condition commonly managed with footwear and orthotic interventions. The objective of this study was to identify factors associated with a successful treatment response in people with 1st MTPJ OA provided with prefabricated orthoses or rocker-sole footwear as part of a randomised clinical trial. Methods People with 1st MTPJ OA (n = 88) who participated in a randomised trial were allocated to receive prefabricated foot orthoses (n = 47) or rocker-sole footwear (n = 41) and completed a baseline questionnaire including information on demographics, anthropometrics, general health, pain characteristics (including the Foot Health Status Questionnaire [FHSQ] and Foot Function Index [FFI]) and perceptions of the interventions, and a clinical assessment of foot posture, range of motion, radiographic severity and in-shoe plantar pressures. Adherence was documented using diaries. At 12 weeks, participants documented their perception of improvement on a 15-point scale. Those reporting at least moderate improvement on this scale were classified as ‘responders’. Results There were 29 responders (62%) in the orthoses group and 16 responders (39%) in the rocker-sole group. In the orthoses group, responders had greater baseline pain severity while walking, a higher FFI difficulty score, and wore their orthoses more frequently. In the rocker-sole group, responders had a higher FFI stiffness score and greater radiographic severity. However, the accuracy of these variables in identifying responders in each group was modest (62 and 53%, respectively). Conclusion The response to prefabricated orthoses or rocker-sole footwear in people with 1st MTPJ OA is related to measures of increased pain and disease severity. However, the overall classification accuracy associated with these factors is not sufficient for identifying individuals who are most likely to benefit from these interventions. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12613001245785

Abstract Background This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA). Methods Ninety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model. Discussion This study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts. Trial registration Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482 . Registered on 28 April 2016.