Association of Bone Shape and Alignment Analyzed Using Statistical Shape Modeling With Severity of First Metatarsophalangeal Joint Osteoarthritis.

OBJECTIVE: We aimed to explore the relationship between bone shape and radiographic severity in individuals with first metatarsophalangeal joint osteoarthritis (first MTP joint OA). METHODS: Weightbearing lateral and dorsoplantar radiographs were obtained for the symptomatic foot of 185 participants (105 females, aged 22 to 85 years) with clinically diagnosed first MTP joint OA. Participants were classified into none/mild, moderate, or severe categories using a standardized atlas. An 80-point model for lateral radiographs and 77-point model for dorsoplantar radiographs was used to define independent modes of variation using statistical shape modeling software. Odds ratios adjusted for confounders were calculated using ordinal regression to determine the association between radiographic severity and mode scores. RESULTS: After assessment and grading of radiographs, 35 participants (18.9%) were included in the none/mild first MTP joint OA severity category, 69 (37.2%) in the moderate severity category, and 81 (43.7%) in the severe category. For lateral-view radiographs, 16 modes of variation were included, which collectively represented 83.2% of total shape variance. Of these, four modes were associated with radiographic severity. For dorsoplantar-view radiographs, 15 modes of variation were included, representing 82.6% of total shape variance. Of these, six modes were associated with radiographic severity. CONCLUSIONS: Variations in the shape and alignment of the medial cuneiform, first metatarsal, and proximal and distal phalanx of the hallux are significantly associated with radiographic severity of first MTP joint OA. Prospective studies are required to determine whether bone shape characteristics are associated with the development and/or progression of this condition.

Categorization and recommendations for outcome measures for lower limb absence by an expert panel.

BACKGROUND: Understanding the psychometric strengths and limitations of outcome measures for use with people with lower limb absence (LLA) is important for selecting measures suited to evaluating patient outcomes, answering clinical and research questions, and informing health care policy. The aim of this project was to review the current psychometric evidence on outcome measures in people with LLA to determine which measures should be included in a stakeholder consensus process. METHODS: An expert panel was assembled, and a 3-stage review process was used to categorize outcome measures identified in a systematic literature review into 3 distinct categories (recommended for measures with better than adequate psychometric properties; recommended with qualification; and unable to recommend). Panelists were asked to individually categorize measures based on results of a systematic review of identified measures' psychometric properties. Each measure's final categorization was based on ≥70% agreement by all panelists. RESULTS: No outcome measure attained the ≥70% consensus threshold needed to achieve a rating of "recommend." Hence, panelists suggested combining "recommend" and "recommend with qualifications" into a single category of "recommend with qualifications." Using this approach, consensus was reached for 59 of 60 measures. Consensus could not be reached on 1 outcome measure (socket comfort score). Thirty-six outcome measures were categorized as "unable to recommend" based on available evidence; however, 23 (12 patient-reported measures and 11 performance-based measures) demonstrated adequate psychometric properties in LLA samples and were thus rated as "recommend with qualification" by the expert panel. The panel of experts were able to recommend 23 measures for inclusion in the subsequent stakeholder review. A key strength of this process was bringing together international researchers with extensive experience in developing and/or using LLA outcome measures who could assist in identifying psychometrically sound measures to include in a subsequent stakeholder consensus process. CONCLUSION: The above categorizations represent the current state of psychometric evidence on outcome measures for people with LLA and hence may change over time as additional research becomes available. The results will be used to achieve wider consensus from clinicians, health policymakers, health clinic managers, researchers, and end users (i.e., individuals with LLA) on outcome measures for the International Society of Prosthetics and Orthotics lower limb Consensus Outcome Measures for Prosthetic and Amputation ServiceS.

Psychometric properties of outcome measures for lower-limb absence: A protocol for a systematic review.

BACKGROUND: Outcome measures are an important part of clinical practice to assist with the care of individuals with lower-limb absence (LLA). They aid with the devising and evaluation of rehabilitation plans, and guide decisions regarding the provision and funding of prosthetic services worldwide. To date, no outcome measure has been identified as a gold standard for use in individuals with LLA. Furthermore, the large number of outcome measures available has created uncertainty regarding outcome measures that are most appropriate for individuals with LLA. OBJECTIVE: To critically appraise the existing literature related to the psychometric properties of outcome measures for use in individuals with LLA and provide evidence as to which outcome measures may be most appropriate for this clinical population. STUDY DESIGN: This is a systematic review protocol. METHODS: CINAHL, Embase, MEDLINE (PubMed), and PsycINFO databases will be searched using a combination of Medical Subject Headings terms and keywords. Search terms that define the population (people with LLA or amputation), intervention (outcome measures), and outcome (psychometric properties) will be used to identify studies. The reference lists of included studies will be hand-search to identify other pertinent articles, with a further search conducted through Google Scholar to ensure that all studies not yet indexed through MEDLINE are captured. Full-text peer-reviewed journal studies published in English will be included, with no date limit set. Included studies will be appraised using the 2018 and 2020 COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklists. Data extraction and study appraisal will be completed by two authors, with a third author serving as an adjudicator. Quantitative synthesis will be used to summarize characteristics of the included studies, with kappa statistics used to determine agreement between authors for study inclusion and the application of COSMIN. Qualitative synthesis will be conducted to report on both quality of the included studies and psychometric properties of the included outcome measures. CONCLUSION: This protocol was designed to identify, appraise, and summarize patient-reported and performance-based outcome measures that have been psychometrically tested in people with LLA. Results from this review will be used to guide a consensus process on outcome measure use for people with LLA.Systematic review registration: PROSPERO registry number: CRD42020217820.

Recommendations from the ISPO lower-limb COMPASS: Patient-reported and performance-based outcome measures.

BACKGROUND: Outcome measures (patient-reported and performance-based) are used widely but not uniformly within the clinical setting for individuals with lower-limb absence (LLA). The need for more detailed information by funding bodies, service planners and providers, and researchers requires the systematic and routine use of outcome measures. Currently, there is no consensus on which outcome measure(s) should be used for individuals with LLA. The aim of the International Society of Prosthetics and Orthotics (ISPO) lower-limb Consensus Outcome Measures for Prosthetic and Amputation Services (COMPASS) was to produce a recommended list of outcome measures to be actively promoted for routine use within clinical practice before and after an episode of care. METHODS: Between May and June 2021, 46 users, clinicians, researchers, managers, and policymakers working in the field of LLA and prosthetic users met virtually. Consensus participants were first asked to complete an online survey with questions based on the results from a systematic review and the outcomes from an expert panel. A modified Delphi technique was used to determine outcome measures for use in routine clinical practice. This paper discusses the ISPO lower-limb COMPASS process from which recommendations were made. RESULTS: The ISPO lower-limb COMPASS resulted in the following 6 recommendations: (1) Amputee Mobility Predictor, Timed Up and Go, Two-Minute Walk Test, Prosthetic Evaluation Questionnaire-Residual Limb Health, Prosthetic Evaluation Questionnaire-Utility, and Trinity Amputation and Prosthesis Experience Scales-Revised, which make up the ISPO lower-limb COMPASS ; (2) Comprehensive High-Level Activity Mobility Predictor and Six-Minute Walk Test are 2 additional outcome measures recommended for higher-activity-level individuals with LLA, which make up the COMPASS+ ; (3) Patient-Specific Function Scale makes up the COMPASS Adjunct ; (4) a generic health-related quality of life outcome measure such as the European Quality of Life-5D-5L or Patient-Reported Outcomes Measurement Information System-29 item can be used to supplement the COMPASS; (5) outcome measures suited to low- and middle-income countries need to be developed with a focus on activities such as sitting cross-legged, kneeling, squatting, and other culturally important mobility-related activities; and (6) translation, validation, and open sharing of translated outcome measures included in the COMPASS, COMPASS+, and COMPASS Adjunct occurs. CONCLUSION: The above recommendations represent the current status of knowledge on outcome measures for LLA based on research and international consensus and hence, will change over time. This work has been developed for clinicians and researchers to improve knowledge on outcome measures to guide clinical decision-making and future research initiatives.

Characterisation of first metatarsophalangeal joint osteoarthritis using magnetic resonance imaging.

INTRODUCTION/OBJECTIVES: First metatarsophalangeal joint (MTP) joint osteoarthritis (OA) is prevalent, although the pathology of this condition is poorly understood. This study aimed to determine if there were differences in magnetic resonance imaging (MRI) characteristics of the first MTP joint between individuals with and without first MTP joint OA. METHOD: This cross-sectional study compared 22 participants with first MTP joint OA to 22 control participants without first MTP joint OA (matched for age, sex, and body mass index). Participants underwent MRI of their first MTP joint and osteophytes, bone marrow lesions, subchondral cysts, effusion-synovitis, joint space narrowing, and cartilage loss were documented using an atlas of first MTP joint OA. Associations of MRI characteristics with the presence of first MTP joint OA were then determined. RESULTS: The presence of first MTP joint OA was associated with increased severity of osteophytes (dorsal metatarsal head, plantar metatarsal head, and dorsal proximal phalanx), bone marrow lesions (metatarsal head and proximal phalanx), cysts of the metatarsal head, effusion-synovitis (dorsal aspect), joint space narrowing (metatarsal-proximal phalanx; metatarsal-sesamoids), and cartilage loss. In contrast, there were no statistically significant associations for bone marrow lesions of the sesamoids, cysts of the proximal phalanx, or effusion-synovitis (plantar aspect). CONCLUSIONS: Osteophytes, bone marrow lesions, subchondral cysts, effusion-synovitis, joint space narrowing, and cartilage loss are characteristic MRI features of first MTP joint OA. First MTP joint OA is a disease of multiple joint tissues and this has implications for the assessment and management of this condition. Key Points • First metatarsophalangeal joint osteoarthritis is a disease of multiple joint tissues. • Osteophytes, bone marrow lesions, subchondral cysts, effusion-synovitis, joint space narrowing, and cartilage loss are characteristic MRI features of first metatarsophalangeal joint osteoarthritis. • These findings have implications for the assessment and management of this condition.

Structural Characteristics Associated With Radiographic Severity of First Metatarsophalangeal Joint Osteoarthritis.

OBJECTIVE: To determine whether foot structure varies according to the presence and radiographic severity of first metatarsophalangeal (MTP) joint osteoarthritis (OA). METHODS: Weight-bearing dorsiplantar and lateral radiographs were obtained for the symptomatic foot of 185 participants (105 women, ages 22-85 years) with clinically diagnosed first MTP joint OA. A validated atlas was used to classify participants as having radiographic first MTP joint OA and to stratify into 3 categories of severity (none/mild, moderate, severe). Bone length and width and angular measures of the forefoot and medial arch were performed on radiographs, and differences between categories were compared using univariate general linear models, adjusting for confounders. RESULTS: A total of 150 participants were categorized as having radiographic first MTP joint OA, and participants were further stratified into none/mild (n = 35), moderate (n = 69), or severe (n = 81) OA categories. Participants with radiographically defined first MTP joint OA displayed a greater hallux abductus interphalangeal angle. Greater radiographic severity of first MTP joint OA was associated with a larger hallux abductus interphalangeal angle, a wider first metatarsal and proximal phalanx, and a smaller intermetatarsal angle. No differences in medial arch measurements were observed between the categories. CONCLUSION: First ray alignment and morphology differed according to the presence and severity of first MTP joint OA. Prospective studies are required to determine whether the observed differences are a cause or consequence of OA.

Associations of foot and ankle characteristics with knee symptoms and function in individuals with patellofemoral osteoarthritis.

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 < 0.05 was used to determine the association between foot and ankle charateristics, with knee symptoms and function, adjusting for age. RESULTS: 188 participants (126 [67%] women, mean [SD] age of 59.9 [7.1] years, BMI 29.3 [5.6] kg/m2) with symptomatic PFOA were included in this study. Lower weightbearing ankle dorsiflexion range of motion had a small significant association with higher average knee pain (partial r = - 0.272, p < 0.001) and maximum knee pain during stair ambulation (partial r = - 0.164, p = 0.028), and lower scores on the AKPS (indicative of greater disability; partial r = 0.151, p = 0.042). Higher FPI scores (indicating a more pronated foot posture) and greater midfoot mobility (foot mobility magnitude) were significantly associated with fewer repeated single step-ups (partial r = - 0.181, p = 0.023 and partial r = - 0.197, p = 0.009, respectively) and double-leg sit-to-stands (partial r = - 0.202, p = 0.022 and partial r = - 0.169, p = 0.045, respectively) to knee pain onset, although the magnitude of these relationships was small. The amount of variance in knee pain and disability explained by the foot and ankle characteristics was small (R2-squared 2 to 8%). CONCLUSIONS: Lower weightbearing ankle dorsiflexion range of motion, a more pronated foot posture, and greater midfoot mobility demonstrated small associations with worse knee pain and greater disability in individuals with PFOA. Given the small magnitude of these relationships, it is unlikely that interventions aimed solely at addressing foot and ankle mobility will have substantial effects on knee symptoms and function in this population. TRIAL REGISTRATION: The RCT was prospectively registered on 15 March 2017 with the Australia and New Zealand Clinical Trials Registry ( ANZCTRN12617000385347 ).

Can radiographic patellofemoral osteoarthritis be diagnosed using clinical assessments?

INTRODUCTION: The aim of this study was to determine whether participant characteristics and clinical assessments could identify radiographic osteoarthritis (OA) in individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA). METHODS: Participant characteristics and clinical assessments were obtained from 179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial. Anteroposterior, lateral, and skyline X-rays were taken of the symptomatic knee. The presence of radiographic PFOA was defined as "no or early PFOA" (Kellgren and Lawrence [KL] grade ≤1 in the PF compartment) or "definite PFOA" (KL grade ≥2). Diagnostic test statistics were applied to ascertain which participant characteristics and clinical assessments could identify the presence of definite radiographic PFOA. RESULTS: A total of 118 participants (66%) had definite radiographic PFOA. Univariate analysis identified that older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m2 ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21) were associated with the presence of definite radiographic PFOA. Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%. CONCLUSION: In individuals over 50 years of age with a clinical diagnosis of PFOA, higher BMI, longer pain duration, and fewer repeated single step-ups to pain onset increased the likelihood of radiographic PFOA. However, overall diagnostic accuracy was modest, suggesting that radiographic PFOA cannot be confidently identified using these tests.

Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint.

OBJECTIVE: The present study was undertaken to assess the comparative responsiveness of outcome measures used for the assessment of pain and function in individuals with osteoarthritis (OA) of the first metatarsophalangeal (MTP) joint. METHODS: Eighty-eight patients (mean ± SD age 57.2 ± 10.2 years) with OA of the first MTP joint who participated in a randomized trial completed the Foot Health Status Questionnaire (FHSQ), the Foot Function Index Revised Short Form (FFI-RS), and 100-mm visual analog scales (VAS) of pain and stiffness at baseline and 12 weeks. Responsiveness of the subscales for each outcome measure was determined using paired t-tests, Cohen's d coefficient, the standardized response mean (SRM), and the Guyatt index (GI). Sample size estimations were calculated based on minimal important differences (MIDs). RESULTS: All outcome measures were sensitive to change and demonstrated at least medium effect sizes. Three outcome measures exhibited large or very large effect sizes for Cohen's d coefficient, the SRM, and the GI: the FHSQ pain subscale (d = 1.03; SRM 1.10, GI score 1.30), the FFI-RS pain subscale (d = 1.09; SRM 1.05, GI score 1.73), and the 100-mm VAS of pain severity while walking (d = 1.22; SRM 1.07, GI score 1.78). Sample size calculations indicated that between 20 and 33 participants per group would be required to detect MIDs using these measures. CONCLUSION: The FHSQ pain subscale, FFI-RS pain subscale, and the 100-mm VAS of pain severity while walking are the most responsive outcome measures for the assessment of pain and function in individuals with OA of the first MTP joint. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials.

Development and Reproducibility of a First Metatarsophalangeal Joint Osteoarthritis Magnetic Resonance Imaging Scoring System.

OBJECTIVE: To develop a magnetic resonance imaging (MRI) atlas for the assessment of osteoarthritis (OA) of the first metatarsophalangeal (MTP) joint, and to assess its intra- and interexaminer reproducibility. METHODS: MRI (proton density with and without fat suppression) was performed on the first MTP joint of 60 participants (30 participants with first MTP joint OA and 30 participants without first MTP joint OA). Characteristic MRI features of OA were then used to develop an MRI atlas of first MTP joint OA. The atlas assessed osteophytes (dorsal metatarsal head, plantar metatarsal head, dorsal proximal phalanx), bone marrow lesions (metatarsal head, proximal phalanx, sesamoids), cysts (metatarsal head, proximal phalanx), effusion-synovitis (dorsal, plantar), joint space narrowing (metatarsal-proximal phalanx, metatarsal sesamoids), and cartilage loss. To assess the reproducibility of the atlas, 2 examiners independently rated the MRIs of 30 participants on 2 occasions. Intra- and interexaminer reproducibility were determined using percentage agreement and Gwet's AC1. RESULTS: Observations using the atlas demonstrated fair-to-perfect intraexaminer reproducibility (percentage agreement from 67% to 100%, and Gwet's AC1 from 0.38 to 1.00) and fair-to-almost-perfect interexaminer reproducibility (percentage agreement from 67% to 98%, and Gwet's AC1 from 0.40 to 0.96). CONCLUSION: An MRI scoring system for the assessment of OA of the first MTP joint has been developed. The atlas demonstrates excellent intra- and interexaminer reproducibility. The atlas has the potential to allow for a better understanding of the cause(s) of pain in first MTP joint OA.

Immediate effects of foot orthoses on lower limb biomechanics, pain, and confidence in individuals with patellofemoral osteoarthritis.

BACKGROUND: Foot orthoses are a recommended treatment for patellofemoral (PF) pain and a number of lower limb osteoarthritic (OA) conditions. However, their mechanism of effect is poorly understood. RESEARCH QUESTION: To compare the immediate effects of foot orthoses and flat inserts on lower limb biomechanics, knee pain and confidence in individuals with PFOA. METHODS: Twenty-one participants (14 females; mean ± SD age 58 ± 8 years) with PFOA underwent three-dimensional motion analysis during level-walking, stair ascent, and stair descent under three footwear conditions: (i) their own shoes; (ii) prefabricated foot orthoses; and (iii) flat shoe inserts. Participants reported their average levels of knee pain and confidence after each task. Data were analysed with repeated-measures analysis of variance (ANOVA), effect sizes (partial eta squared), and Bonferroni post-hoc tests. RESULTS: During level-walking, there was a significant main effect of foot orthoses on peak ankle dorsiflexion angle (F2 = 0.773, p < 0.001, ƞ2 = 0.773) and peak ankle external dorsiflexion moment (F2 = 0.356, p = 0.046, ƞ2 = 0.356). Foot orthoses decreased the peak ankle dorsiflexion angle compared to the flat insert and shoe conditions, and decreased the peak ankle external dorsiflexion moment relative to flat inserts. During stair descent, there was a significant main effect of foot orthoses on peak ankle external dorsiflexion moment (F2 = 0.823, p = 0.006, ƞ2 = 0.738), with a trend towards lower peak dorsiflexion moment for foot orthoses compared to the flat insert and shoe conditions. No significant main effects were observed during stair ascent. No other lower limb biomechanical changes were observed across all three conditions. Knee pain and confidence scores were not significantly different across the three conditions. SIGNIFICANCE: Prefabricated foot orthoses altered sagittal plane biomechanics of the ankle during level-walking and stair descent in individuals with PFOA. Further research is required to determine whether these changes are clinically beneficial.

The efficacy of foot orthoses in individuals with patellofemoral osteoarthritis: a randomised feasibility trial.

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% drop-out, with results reported using descriptive statistics. Secondary outcomes included average and maximum pain severity (100 mm visual analogue scale), Anterior Knee Pain Scale, and Knee injury and Osteoarthritis Outcome Score, analysed using analysis of covariance. RESULTS: Twenty-six participants (16 women; mean (SD) age of 60 (8) years) with PFOA were recruited. All feasibility parameters were exceeded, with three participants recruited per week, > 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).

The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis.

INTRODUCTION: Patellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity. METHODS AND ANALYSIS: The FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses. ETHICS AND DISSEMINATION: Ethical approval has been granted by La Trobe University's Human Ethics Committee and The University of Queensland's Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources. TRIAL REGISTRATION NUMBER: ANZCTRN12617000385347; Pre-results.

Effects of heel lifts on lower limb biomechanics and muscle function: A systematic review.

BACKGROUND: Heel lifts, placed inside footwear are recommended for the management of numerous musculoskeletal conditions. Despite the potential therapeutic benefit of heel lifts, the mechanism(s) by which they exert their effects is unclear. The aim of this systematic review was to synthesise reported findings and summarise the effects of heel lifts on lower limb biomechanics and muscle function. RESEARCH QUESTION: Do heel lifts affect lower limb biomechanics and muscle function during walking and running? METHODS: Electronic databases (MEDLINE, EMBASE, CINAHL, SPORTDiscus, AMED) were searched from inception to April 2018. Studies were included if they (i) included participants without a limb length discrepancy or neurological condition, (ii) evaluated the effect of bilateral heel lifts that were removable (attached to the participants' foot (barefoot) or inserted inside footwear) or an existing feature of a shoe, and (iii) assessed lower limb biomechanics or muscle function during walking or running in asymptomatic or symptomatic participants. RESULTS: A total of 23 studies (377 participants) were included. Study quality, assessed using a Modified Quality Index, ranged from 5 to 13 out of 15. A large number of biomechanical parameters were assessed, but few effects were statistically significant. The differences that were significant and had a large effect size are described below. In asymptomatic participants, heel lifts of 10 mm decreased duration of swing phase (standardised mean difference [SMD] = -1.3) and heel lifts of at least 5 cm decreased velocity (SMD = -0.93) during walking. In asymptomatic participants, heel lifts of 15 mm decreased maximum ankle dorsiflexion angle (SMD = -1.5) and heel lifts of 12 and 18 mm decreased gastrocnemius muscle tendon unit length (SMD = -0.96) during running. In participants with restricted ankle joint dorsiflexion, heel lifts of 6 and 9 mm increased medial gastrocnemius electromyography amplitude (SMD between 0.68 and 0.98) during walking. In participants with haemophilia, heel lifts of 9 mm increased ankle joint maximum range of motion (SMD = 1.6) during walking. SIGNIFICANCE: Heel lifts affect specific lower limb biomechanical and muscle function parameters during walking and running. The clinical relevance and potential therapeutic benefits of these effects needs further investigation.

Centre of pressure characteristics during walking in individuals with and without first metatarsophalangeal joint osteoarthritis.

OBJECTIVE: The objective of this study was to compare centre of pressure characteristics during walking in individuals with and without first metatarsophalangeal joint osteoarthritis (1st MTPJ OA), in order to provide insights into alterations in foot function associated with this condition. METHODS: Twenty people with 1st MTPJ OA and 20 asymptomatic controls matched for age, sex and body mass index underwent gait analysis using the emed®-x400 plantar pressure system (Novel GmbH, Germany). Average and maximum centre of pressure velocity and lateral-medial force index during loading, midstance, terminal stance and preswing were compared between the groups. RESULTS: During the preswing phase of gait, maximum centre of pressure velocity was significantly slower in individuals with 1st MTPJ OA (0.78 ±â€¯0.19 vs 1.13 ±â€¯0.36 m/sec; p = 0.003), and both average and maximum lateral-medial force indices were significantly higher in individuals with 1st MTPJ OA (0.98 ±â€¯0.14 vs 0.82 ±â€¯0.13; p < 0.001 and 1.37 ±â€¯0.29 vs 1.15 ±â€¯0.15; p = 0.008, respectively). Non-weightbearing 1st MTPJ dorsiflexion range of motion was significantly associated with maximum centre of pressure velocity (r = 0.54, p < 0.001) and average lateral-medial force index (r = -0.44, p = 0.004) during preswing. CONCLUSIONS: Individuals with 1st MTPJ OA exhibit significant differences in centre of pressure characteristics during propulsion, possibly due to decreased range of available 1st MTPJ dorsiflexion.

Age-related differences in foot mobility in individuals with patellofemoral pain.

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 < 0.001) and foot mobility magnitude (p = 0.006). Post-hoc analyses revealed that midfoot height mobility differed across all three groups (moderate to large effect sizes), and that foot mobility magnitude was significantly less in those aged 40-50 years compared to those aged 18-25 years (moderate effect size). There were no significant main effects for age for midfoot width 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.

Foot orthoses for plantar heel pain: a systematic review and meta-analysis.

OBJECTIVE: To investigate the effectiveness of foot orthoses for pain and function in adults with plantar heel pain. DESIGN: Systematic review and meta-analysis. The primary outcome was pain or function categorised by duration of follow-up as short (0 to 6 weeks), medium (7 to 12 weeks) or longer term (13 to 52 weeks). DATA SOURCES: Medline, CINAHL, SPORTDiscus, Embase and the Cochrane Library from inception to June 2017. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies must have used a randomised parallel-group design and evaluated foot orthoses for plantar heel pain. At least one outcome measure for pain or function must have been reported. RESULTS: A total of 19 trials (1660 participants) were included. In the short term, there was very low-quality evidence that foot orthoses do not reduce pain or improve function. In the medium term, there was moderate-quality evidence that foot orthoses were more effective than sham foot orthoses at reducing pain (standardised mean difference -0.27 (-0.48 to -0.06)). There was no improvement in function in the medium term. In the longer term, there was very low-quality evidence that foot orthoses do not reduce pain or improve function. A comparison of customised and prefabricated foot orthoses showed no difference at any time point. CONCLUSION: There is moderate-quality evidence that foot orthoses are effective at reducing pain in the medium term, however it is uncertain whether this is a clinically important change.

Predictors of response to prefabricated foot orthoses or rocker-sole footwear in individuals with first metatarsophalangeal joint osteoarthritis.

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.

Biomechanical Effects of Prefabricated Foot Orthoses and Rocker-Sole Footwear in Individuals With First Metatarsophalangeal Joint Osteoarthritis.

OBJECTIVE: To evaluate the effects of prefabricated foot orthoses and rocker-sole footwear on spatiotemporal parameters, hip and knee kinematics, and plantar pressures in people with first metatarsophalangeal (MTP) joint osteoarthritis (OA). METHODS: A total of 102 people with first MTP joint OA were randomly allocated to receive prefabricated foot orthoses or rocker-sole footwear. The immediate biomechanical effects of the interventions (compared to usual footwear) were examined using a wearable sensor motion analysis system and an in-shoe plantar pressure measurement system. RESULTS: Spatiotemporal/kinematic and plantar pressure data were available from 88 and 87 participants, respectively. The orthoses had minimal effect on spatiotemporal or kinematic parameters, while the rocker-sole footwear resulted in reduced cadence, percentage of the gait cycle spent in stance phase, and sagittal plane hip range of motion. The orthoses increased peak pressure under the midfoot and lesser toes. Both interventions significantly reduced peak pressure under the first MTP joint, and the rocker-sole shoes also reduced peak pressure under the second through fifth MTP joints and heel. When the effects of the orthoses and rocker-sole shoes were directly compared, there was no difference in peak pressure under the hallux, first MTP joint, or heel; however, the rocker-sole shoes exhibited lower peak pressure under the lesser toes, second through fifth MTP joints, and midfoot. CONCLUSION: Prefabricated foot orthoses and rocker-sole footwear are effective at reducing peak pressure under the first MTP joint in people with first MTP joint OA, but achieve this through different mechanisms. Further research is required to determine whether these biomechanical changes result in improvements in symptoms.

Effectiveness of Foot Orthoses Versus Rocker-Sole Footwear for First Metatarsophalangeal Joint Osteoarthritis: Randomized Trial.

OBJECTIVE: To compare the effectiveness of prefabricated foot orthoses to rocker-sole footwear in reducing foot pain in people with first metatarsophalangeal (MTP) joint osteoarthritis (OA). METHODS: Participants (n = 102) with first MTP joint OA were randomly allocated to receive individualized, prefabricated foot orthoses or rocker-sole footwear. The primary outcome measure was the pain subscale on the Foot Health Status Questionnaire (FHSQ) at 12 weeks. Secondary outcome measures included the function, footwear, and general foot health subscales of the FHSQ; the Foot Function Index; severity of pain and stiffness at the first MTP joint; perception of global improvement; general health status; use of rescue medication and co-interventions to relieve pain; physical activity; and the frequency of self-reported adverse events. RESULTS: The FHSQ pain subscale scores improved in both groups, but no statistically significant difference between the groups was observed (adjusted mean difference 2.05 points, 95% confidence interval [95% CI] -3.61, 7.71; P = 0.477). However, the footwear group exhibited lower adherence (mean ± SD total hours worn 287 ± 193 versus 448 ± 234; P < 0.001), were less likely to report global improvement in symptoms (39% versus 62%; relative risk [RR] 0.63, 95% CI 0.41, 0.99; P = 0.043), and were more likely to experience adverse events (39% versus 16%; RR 2.47, 95% CI 1.12, 5.44; P = 0.024) compared to the orthoses group. CONCLUSION: Prefabricated foot orthoses and rocker-sole footwear are similarly effective at reducing foot pain in people with first MTP joint OA. However, prefabricated foot orthoses may be the intervention of choice due to greater adherence and fewer associated adverse events.