Non-surgical interventions for treating osteoarthritis of the big toe joint.

BACKGROUND: Osteoarthritis (OA) affecting the first metatarsophalangeal joint (hallux rigidus) is common and painful. Several non-surgical treatments have been proposed; however, few have been adequately evaluated. Since the original 2010 review, several studies have been published necessitating this update. OBJECTIVES: To determine the benefits and harms of non-surgical treatments for big toe OA. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was February 2023. SELECTION CRITERIA: We included randomised trials that compared any type of non-surgical treatment versus placebo (or sham), no treatment (such as wait-and-see) or other treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. The major outcomes were pain, function, quality of life, radiographic joint structure, adverse events and withdrawals due to adverse events. The primary time point was 12 weeks. We used GRADE to assess the certainty of evidence. MAIN RESULTS: This update includes six trials (547 participants). The mean age of participants ranged from 32 to 62 years. Trial durations ranged from 4 to 52 weeks. Treatments were compared in single trials as follows: arch-contouring foot orthoses versus sham inserts; shoe-stiffening inserts versus sham inserts; intra-articular injection of hyaluronic acid versus saline (placebo) injection; arch-contouring foot orthoses versus rocker-sole footwear; peloid therapy versus paraffin therapy; and sesamoid mobilisation, flexor hallucis longus strengthening and gait training plus physical therapy versus physical therapy alone. Certainty of the evidence was limited by the risk of bias and imprecision. Meta-analysis was not performed due to the heterogeneity of interventions. We reported numerical data for the 12-week time point for the three trials that used a placebo/sham control group. Arch-contouring foot orthoses versus sham inserts One trial (88 participants) showed that arch-contouring foot orthoses probably lead to little or no difference in pain, function, or quality of life compared to sham inserts (moderate certainty). Mean pain (0-10 scale, 0 no pain) with sham inserts was 3.9 points compared to 3.5 points with arch-contouring foot orthoses; a difference of 0.4 points better (95% (CI) 0.5 worse to 1.3 better). Mean function (0-100 scale, 100 best function) with sham inserts was 73.3 points compared to 65.5 points with arch-contouring foot orthoses; a difference of 7.8 points worse (95% CI 17.8 worse to 2.2 better). Mean quality of life (-0.04-100 scale, 100 best score) with sham inserts was 0.8 points compared to 0.8 points with arch-contouring foot orthoses group (95% CI 0.1 worse to 0.1 better). Arch-contouring foot orthoses may show little or no difference in adverse events and withdrawal due to adverse events compared to sham inserts (low certainty). Adverse events (mostly foot pain) were reported in 6 out of 41 people with sham inserts and 4 out of 47 people with arch-contouring foot orthoses (RR 0.58, 95% CI 0.18 to 1.92). Withdrawals due to adverse events were reported in 0 out of 41 people with sham inserts and 1 out of 47 people with arch-contouring foot orthoses (Peto OR 6.58, 95% CI 0.13 to 331). Shoe-stiffening inserts versus sham inserts One trial (100 participants) showed that shoe-stiffening inserts probably lead to little or no difference in pain, function, or quality of life when compared to sham inserts (moderate certainty). Mean pain (0-100 scale, 0 no pain) with sham inserts was 63.8 points compared to 70.1 points with shoe-stiffening inserts; a difference of 6.3 points better (95% CI 0.5 worse to 13.1 better). Mean function (0-100 scale, 100 best function) with sham inserts was 81.0 points compared to 84.9 points with shoe-stiffening inserts; a difference of 3.9 points better (95% CI 3.3 worse to 11.1 better). Mean quality of life (0-100 scale, 100 best score) with sham inserts was 53.2 points compared to 53.3 points with shoe-stiffening inserts; a difference of 0.1 points better (95% CI 3.7 worse to 3.9 better). Shoe-stiffening inserts may show little or no difference in adverse events and withdrawal due to adverse events, compared to sham inserts (low certainty). Adverse events (mostly foot pain, blisters, and spine/hip pain) were reported in 31 out of 51 people with sham inserts and 29 out of 49 people with shoe-stiffening inserts (RR 0.94, 95% CI 0.42 to 2.08). Withdrawals due to adverse events were reported in 1 out of 51 people with sham inserts and 2 out of 49 people with shoe-stiffening inserts (Peto OR 2.08, 95% CI 0.19 to 22.23). Hyaluronic acid versus placebo One trial (151 participants) showed that a single intra-articular injection of hyaluronic acid probably leads to little or no difference in pain or function compared to placebo (moderate certainty). Mean pain (0-100 scale, 0 no pain) with placebo was 72.5 points compared to 68.2 points with hyaluronic acid; a difference of 4.3 points better (95% CI 2.1 worse to 10.7 better). Mean function (0-100 scale, 100 best function) was 83.4 points with placebo compared to 85.0 points with hyaluronic acid; a difference of 1.6 points better (95% CI 4.6 worse to 7.8 better). Hyaluronic acid may provide little or no difference in quality of life (0-100 scale, 100 best score) which was 79.9 points with placebo compared to 82.9 points with hyaluronic acid; a difference of 3.0 better (95% CI 1.4 worse to 7.4 better; low certainty). There may be fewer adverse events with hyaluronic acid compared to placebo. Adverse events (mostly pain at the injection site) were reported in 43 out of 76 people with placebo compared with 27 out of 75 people with hyaluronic acid (RR 0.64, 95% CI 0.44 to 0.91; low certainty). No participants withdrew from either group due to adverse events. The effects on radiographic joint structure were not reported in any study. AUTHORS' CONCLUSIONS: The existing evidence regarding the benefits and harms of non-surgical treatments for big toe OA is limited. There is moderate-certainty evidence, based upon three single placebo/sham-controlled trials, that there are no clinically important benefits of arch-contouring foot orthoses, shoe-stiffening inserts, or a single intra-articular injection of hyaluronic acid. Further placebo-controlled trials are needed to evaluate the effectiveness of non-surgical treatments for big toe OA.

Footwear and Falls in Long-Term Residential Aged Care Facilities: An Analysis of Video Capture Data.

INTRODUCTION: Several footwear characteristics have been shown to affect balance and gait patterns and may therefore influence the risk of falling in older adults. However, attributing a link between footwear and falls is inherently difficult as it often relies on self-report which may be inaccurate. METHODS: Archival video recordings of falls that occurred in two long-term residential aged care facilities were initially screened to determine whether the footwear worn at the time (barefoot, socks, slippers/sandals, or shoes) could be documented. These falls were then independently evaluated by three additional assessors and a meeting was held to obtain consensus in relation to whether the footwear could have potentially contributed to the fall, and what mechanism may have been responsible. Cross-tabulations were performed in relation to footwear type and fall characteristics (proposed mechanism and fall direction). RESULTS: There were 300 falls experienced by 118 older adults aged 58 years-98 years (mean age 82.8 years, SD 7.6). Of these falls, footwear could be ascertained in 224 (75%). After the consensus meeting, the proportion of falls considered to be potentially related to footwear was 40 (18%). The likelihood of footwear contributing to the fall was highest when participants were wearing socks (14/19 falls; 74% of all footwear-related falls), followed by being barefoot (2/6 falls; 33%), wearing slippers/sandals (17/100 falls; 17%), and wearing shoes (7/99 falls, 7%). CONCLUSION: Footwear could be a potential contributor to a substantial number of falls in residential aged care. Wearing socks would appear to place an older person at risk of future falls and should therefore be avoided in this population.

Footwear, Orthoses, and Insoles and Their Effects on Balance in Older Adults: A Scoping Review.

BACKGROUND: Footwear, orthoses, and insoles have been shown to influence balance in older adults; however, it remains unclear which features, singular or in combination, are considered optimal. The aim of this scoping review was to identify and synthesise the current evidence regarding how footwear, orthoses, and insoles influence balance in older adults. Four electronic databases (MEDLINE, CINAHL, Embase, and AMED) were searched from inception to October 2023. Key terms such as "shoe*," "orthoses," "postural balance" and "older people" were employed in the search strategy. Studies meeting the following criteria were included: (i) participants had a minimum age ≥60 years, and were free of any neurological, musculoskeletal, and cardiovascular diseases; (ii) an active intervention consisting of footwear, foot orthoses, or insoles was evaluated; and (iii) at least one objective outcome measure of balance was reported. SUMMARY: A total of 56 studies from 17 different countries were included. Three study designs were utilised (cross-sectional study, n = 44; randomised parallel group, n = 6; cohort study n = 6). The duration of studies varied considerably, with 41 studies evaluating immediate effects, 14 evaluating effects from 3 days to 12 weeks, and 1 study having a duration of 6 months. Seventeen different interventions were evaluated, including/consisting of textured insoles (n = 12), heel elevation (n = 8), non-specific standardised footwear and changes in sole thickness or hardness (n = 7 each), sole geometry or rocker soles, contoured or custom insoles and high collar height (n = 6 each), insole thickness or hardness and vibrating insoles (n = 5 each), outsole tread (n = 4), minimalist footwear and slippers (n = 3 each), balance-enhancing shoes, footwear fit, socks, and ankle-foot orthoses (n = 2 each), and eversion insoles, heel cups, and unstable footwear (n = 1 each). Twenty-three different outcomes were assessed, and postural sway was the most common (n = 20), followed by temporo-spatial gait parameters (n = 17). There was uncertainty regarding intervention effectiveness. Overall, features such as secure fixation, a textured insole, a medium-to-hard density midsole and a higher ankle collar, in isolation, were able to positively impact balance. Conversely, footwear with an elevated heel height and the use of socks and slippers impaired balance. KEY MESSAGES: There is a substantial body of literature exploring the effects of footwear, orthoses, and insoles on balance in older adults. However, considerable uncertainty exists regarding the efficacy of these interventions due to variability in methodological approaches. Further high-quality research is necessary to determine whether a singular intervention or a combination of interventions is most effective for enhancing balance in older adults.

Efficacy of non-surgical interventions for midfoot osteoarthritis: a systematic review.

This systematic review aims to investigate the efficacy of non-surgical interventions for midfoot osteoarthritis (OA). Key databases and trial registries were searched from inception to 23 February 2023. All trials investigating non-surgical interventions for midfoot OA were included. Quality assessment was performed using the National Institutes of Health Quality Assessment Tool. Outcomes were pain, function, health-related quality of life, and adverse events. Effects (mean differences, standardised mean differences, risk ratios) were calculated where possible for the short (0 to 12 weeks), medium (> 12 to 52 weeks), and long (> 52 weeks) term. Six trials (231 participants) were included (one feasibility trial and five case series) - all were judged to be of poor methodological quality. Two trials reported arch contouring foot orthoses to exert no-to-large effects on pain in the short and medium term, and small-to-very-large effects on function in the short and medium term. Two trials reported shoe stiffening inserts to exert medium-to-huge effects on pain in the short term, and small effects on function in the short term. Two trials of image-guided intra-articular corticosteroid injections reported favourable effects on pain in the short term, small effects on pain and function in the medium term, and minimal long term effects. Two trials reported minor adverse events, and none reported health-related quality of life outcomes. The current evidence suggests that arch contouring foot orthoses, shoe stiffening inserts and corticosteroid injections may be effective for midfoot OA. Rigorous randomised trials are required to evaluate the efficacy of non-surgical interventions for midfoot OA.

Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (HEALTHY): a randomised trial.

OBJECTIVES: To compare the efficacy of in-shoe heel lifts to calf muscle eccentric exercise in reducing pain and improving function in mid-portion Achilles tendinopathy. METHODS: This was a parallel-group randomised superiority trial at a single centre (La Trobe University Health Sciences Clinic, Discipline of Podiatry, Melbourne, Victoria, Australia). One hundred participants (52 women and 48 men, mean age 45.9, SD 9.4 years) with clinically diagnosed and ultrasonographically confirmed mid-portion Achilles tendinopathy were randomly allocated to either a (1) heel lifts (n=50) or (2) eccentric exercise (n=50) group. The primary outcome measure was the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire at 12 weeks. Differences between groups were analysed using intention to treat with analysis of covariance. RESULTS: There was 80% follow-up of participants (n=40 per group) at 12 weeks. The mean VISA-A score improved by 26.0 points (95% CI 19.6 to 32.4) in the heel lifts group and by 17.4 points (95% CI 9.5 to 25.3) in the eccentric exercise group. On average, there was a between-group difference in favour of the heel lifts for the VISA-A (adjusted mean difference 9.6, 95% CI 1.8 to 17.4, p=0.016), which approximated, but did not meet our predetermined minimum important difference of 10 points. CONCLUSION: In adults with mid-portion Achilles tendinopathy, heel lifts were more effective than calf muscle eccentric exercise in reducing pain and improving function at 12 weeks. However, there is uncertainty in the estimate of effect for this outcome and patients may not experience a clinically worthwhile difference between interventions. TRIAL REGISTRATION NUMBER: ACTRN12617001225303.

Foot orthoses for first metatarsophalangeal joint osteoarthritis: study protocol for the FORT randomised controlled trial.

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.

Corticosteroid injection for plantar heel pain: a systematic review and meta-analysis.

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 .

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.

Effectiveness of foot orthoses for the prevention of lower limb overuse injuries in naval recruits: a randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of prefabricated foot orthoses for the prevention of lower limb overuse injuries in naval recruits. METHODS: This study was a participant-blinded and assessor-blinded, parallel-group randomised controlled trial. Three-hundred and six participants aged 17-50 years who undertook 11 weeks of initial defence training at the Royal Australian Navy Recruit School (Cerberus, Australia) were randomised to a control group (flat insoles, n=153) or an intervention group (contoured, prefabricated foot orthoses, n=153). The combined incidence of medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy and plantar fasciitis/plantar heel pain during the 11-week training period were compared using incidence rate ratios (IRR). Data were analysed using the intention-to-treat principle. RESULTS: Sixty-seven injuries (21.9%) were recorded. The control and intervention group sustained 40 (26.1%) and 27 (17.6%) injuries, respectively (IRR 0.66, 95% CI 0.39 to 1.11, p=0.098). This corresponds to a 34% reduction in risk of developing medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy or plantar fasciitis/plantar heel for the intervention group compared with the control group. Participants in the prefabricated orthoses group were more likely to report at least one adverse event (20.3% vs 12.4%; relative risk (RR) 1.63, 95% CI 0.96 to 2.76; p=0.068; number needed to harm 13, 95% CI 6 to 253). The most common adverse events were foot blisters (n=20, 6.6%), arch pain (n=10, 3.3%) and shin pain (n=8, 2.6%). CONCLUSION: Prefabricated foot orthoses may be beneficial for reducing the incidence of lower limb injury in naval recruits undertaking defence training. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry: ACTRN12615000024549.

Effects of Indoor Footwear on Balance and Gait Patterns in Community-Dwelling Older Women.

BACKGROUND: Footwear worn indoors is generally less supportive than outdoor footwear and may increase the risk of falls. OBJECTIVE: To evaluate balance ability and gait patterns in older women while wearing different styles of indoor footwear: a backless slipper and an enclosed slipper designed to optimise 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, limits of stability, and tandem walking, measured with the NeuroCom® Balance Master) and gait patterns (walking speed, cadence, and step length, measured with the GAITRite® walkway) while wearing (1) socks, (2) backless slippers with a soft sole, and (3) enclosed slippers with a firm sole and Velcro® fastening. Perceptions of the footwear were also documented using a structured questionnaire. RESULTS: Significant overall effects of footwear were observed for postural sway, the limits of stability test (directional control), the tandem walk test (step width and end sway), and temporospatial gait patterns (walking speed, cadence, and step length). No footwear effects were observed for maximum excursion when performing the limits of stability test or for speed when performing the tandem walk test. Post hoc tests indicated that performances were best while wearing the enclosed slippers, intermediate with socks, and worst with backless slippers. The enclosed slippers were perceived to be more attractive, comfortable, and well fitted, but heavier than the backless slippers. Most participants (n = 23; 77%) reported that they would consider wearing the enclosed slippers to reduce their risk of falling. CONCLUSION: Indoor footwear with an enclosed heel, Velcro® fastening, and a firm sole optimises balance and gait compared to backless slippers, and is therefore recommended to reduce the risk of falling.

Preliminary evaluation of prototype footwear and insoles to optimise balance and gait in older people.

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).

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.

Effectiveness of foot orthoses and shock-absorbing insoles for the prevention of injury: a systematic review and meta-analysis.

OBJECTIVE: To investigate the evidence relating to the effectiveness of foot orthoses and shock-absorbing insoles for the prevention of musculoskeletal injury. DESIGN: Systematic review and meta-analysis. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Clinical trials evaluating the effectiveness of foot orthoses and shock-absorbing insoles for the prevention of injury. DATA SOURCES: Cochrane Library, CINAHL, EMBASE, MEDLINE and SPORTDiscus from their inception up to the first week of June 2016. RESULTS: 11 trials that had evaluated foot orthoses and 7 trials that had evaluated shock-absorbing insoles were included. The median Physiotherapy Evidence Database (PEDro) score for trials that had evaluated foot orthoses and shock-absorbing insoles was 5 (range 3-8/10) and 3 (range 1-7/10), respectively. Meta-analysis found that foot orthoses were effective for preventing overall injuries (risk ratio (RR) 0.72, 95% CI 0.55 to 0.94) and stress fractures (RR 0.59, 95% CI 0.45 to 0.76), but not soft-tissue injuries (RR 0.79, 95% CI 0.55 to 1.14). In contrast, shock-absorbing insoles were not effective for preventing overall injuries (RR 0.92, 95% CI 0.73 to 1.16), stress fractures (RR 1.15, 95% CI 0.57 to 2.32) or soft-tissue injuries (RR 0.92, 95% CI 0.74 to 1.15). CONCLUSIONS: Foot orthoses were found to be effective for preventing overall injuries and stress fractures but not soft-tissue injuries, while shock-absorbing insoles were not found to be effective for preventing any injury. However, further well-designed trials will assist the accuracy and precision of the estimates of risk reduction as the quality of the included trials varied greatly.

Effectiveness of customised foot orthoses for Achilles tendinopathy: a randomised controlled trial.

AIM: To evaluate the effectiveness of customised foot orthoses in chronic mid-portion Achilles tendinopathy. METHODS: This was a participant-blinded, parallel-group randomised controlled trial at a single centre (La Trobe University, Melbourne, Australia). One hundred and forty participants aged 18-55 years with mid-portion Achilles tendinopathy were randomised to receive eccentric calf muscle exercises with either customised foot orthoses (intervention group) or sham foot orthoses (control group). Allocation to intervention was concealed. The Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire was completed at baseline, then at 1, 3, 6 and 12 months, with 3 months being the primary end point. Differences between groups were analysed using intention to treat with analysis of covariance. RESULTS: After randomisation into the customised foot orthoses group (n=67) or sham foot orthoses group (n=73), there was 70.7% follow-up of participants at 3 months. There were no significant differences between groups at any time point. At 3 months, the mean (SD) VISA-A score was 82.1 (16.3) and 79.2 (20.0) points for the customised and sham foot orthosis groups, respectively (adjusted mean difference (95% CI)=2.6 (-2.9 to 8.0), p=0.353). There were no clinically meaningful differences between groups in any of the secondary outcome measures. CONCLUSIONS: Customised foot orthoses, prescribed according to the protocol in this study, are no more effective than sham foot orthoses for reducing symptoms and improving function in people with mid-portion Achilles tendinopathy undergoing an eccentric calf muscle exercise programme. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry: number ACTRN12609000829213.

Comparison of the responsiveness of the foot health status questionnaire and the Manchester foot pain and disability index in older people.

BACKGROUND: In recent years, several questionnaires have been developed for the assessment of foot health and its impact on quality of life. In order for these tools to be useful outcome measures in clinical trials, their ability to detect change over time (responsiveness) needs to be determined. Therefore, the aim of this study was to assess the responsiveness of two commonly-used questionnaires in older people with foot pain. METHODS: Participants (n = 59; 24 women and 35 men, mean age [SD] 82.3 [7.8] years) allocated to the intervention arm of a randomised controlled trial assessing the effectiveness of extra-depth footwear compared to usual care completed the Foot Health Status Questionnaire (FHSQ) and Manchester Foot Pain and Disability Index (MFPDI) at baseline and 16 weeks. Responsiveness of the FHSQ subscales (pain, function, footwear and general foot health) and MFPDI subscales (pain, functional limitation and concern about appearance) was determined using (i) paired t-tests, (ii) Cohen's d, (iii) the standardised response mean (SRM), and (iv) the Guyatt index. RESULTS: Overall, the FHSQ pain subscale exhibited the highest responsiveness, as evidenced by a highly significant paired t-test (p <0.001), Cohen's d = 0.63 (medium effect size), SRM = 0.50 (medium effect size) and Guyatt index = 1.70 (huge effect size). The next most responsive measure was the FHSQ function subscale, as evidenced by a borderline paired t-test (p = 0.050), Cohen's d = 0.37 (small effect size), SRM = 0.26 (small effect size) and GI = 1.22 (very large effect size). The FHSQ footwear, FHSQ general foot health and MFPDI pain, functional limitation and concern about appearance subscales demonstrated lower responsiveness, with negligible to medium effect sizes. CONCLUSION: The FHSQ pain and function subscales were most responsive to change in older people with foot pain receiving a footwear intervention. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials of foot disorders.

Rocker-sole footwear versus prefabricated foot orthoses for the treatment of pain associated with first metatarsophalangeal joint osteoarthritis: study protocol for a randomised trial.

BACKGROUND: Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain, stiffness and impaired ambulation. Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition, but their effectiveness has not been rigorously evaluated. This article describes the design of a randomised trial comparing the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis. METHODS: Eighty people with first metatarsophalangeal joint osteoarthritis will be randomly allocated to receive either a pair of rocker-sole shoes (MBT® Matwa, Masai Barefoot Technology, Switzerland) or a pair of individualised, prefabricated foot orthoses (Vasyli Customs, Vasyli Medical™, Queensland, Australia). At baseline, the biomechanical effects of the interventions will be examined using a wireless wearable sensor motion analysis system (LEGSys™, BioSensics, Boston, MA, USA) and an in-shoe plantar pressure system (Pedar®, Novel GmbH, Munich, Germany). The primary outcome measure will be the pain subscale of the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8 and 12 weeks. Secondary outcome measures will include the function, footwear and general foot health subscales of the FHSQ, severity of pain and stiffness at the first metatarsophalangeal joint (measured using 100 mm visual analog scales), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 questionnaire), use of rescue medication and co-interventions to relieve pain, the frequency and type of 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. DISCUSSION: This study is the first randomised trial to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with osteoarthritis of the first metatarsophalangeal joint, and only the third randomised trial ever conducted for this condition. The study has been pragmatically designed to ensure that the findings can be implemented into clinical practice if the interventions are found to be effective, and the baseline biomechanical analysis will provide useful insights into their mechanism of action. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613001245785.

Assessing calf exercise fidelity among people with Achilles tendinopathy using videos recorded via Zoom®: an observational study.

PURPOSE: Exercise fidelity is a fundamental aspect of exercise prescription by physiotherapists. Assessing exercise fidelity via telehealth (videoconference) is potentially useful but its reproducibility has not been assessed. The objective was to evaluate agreement (reproducibility) of video rating of calf exercise fidelity within (over four weeks) and between telehealth raters and compared with live rating. METHODS: Nineteen videos of participants with AT undertaking calf exercises were rated by physiotherapists in person (live) and by watching pre-recorded videos (replicating telehealth). Three forms of agreement were assessed: (i) between live assessment and recorded video (telehealth) assessment; (ii) between telehealth raters (inter-rater); (iii) agreement within telehealth raters over four weeks (intra-rater). RESULTS: There was weak to almost perfect agreement (Kappa = 0.65 to 1.00, rater 1, Kappa = 0.57 to 1.00, rater 2) between the telehealth and live raters. There was moderate to almost perfect agreement (Kappa = 0.65 to 1.00) when assessing intra-rater reliability, aside from one of the six criteria (quality of movement). CONCLUSION: Assessing calf exercise fidelity via videos recorded on Zoom® appears to demonstrate weak or greater agreement versus live rating and over time. Inter-rater agreement was lower, suggesting that the criteria developed may be better suited to use by individual raters over time.Implications for rehabilitationTelehealth assessment (when compared with live, in person assessment) shows a moderate or greater agreement for the majority of assessment criteria when assessing calf exercise fidelity.The calf exercise fidelity criteria developed can be used as an adjunct to assessment and management of people with Achilles Tendinopathy.Intra-rater assessment was shown to be moderately or more consistent over a four-week period when assessing calf exercise fidelity.

Structural Foot Characteristics in People With Midfoot Osteoarthritis: Cross-Sectional Findings From the Clinical Assessment Study of the Foot.

OBJECTIVE: This study compared radiographic measures of foot structure between people with and without symptomatic radiographic midfoot osteoarthritis (OA). METHODS: This was a cross-sectional study of adults aged 50 years and older registered with four UK general practices who reported foot pain in the past year. Bilateral weightbearing dorsoplantar and lateral radiographs were obtained. Symptomatic radiographic midfoot OA was defined as midfoot pain in the last 4 weeks, combined with radiographic OA in one or more midfoot joints (first cuneometatarsal, second cuneometatarsal, navicular-first cuneiform, and talonavicular). Midfoot OA cases were matched 1:1 for sex and age to controls with a 5-year age tolerance. Eleven radiographic measures were extracted and compared between the groups using independent sample t-tests and effect sizes (Cohen's d). RESULTS: We identified 63 midfoot OA cases (mean ± SD age was 66.8 ± 8.0 years, with 32 male and 31 female participants) and matched these to 63 controls (mean ± SD age was 65.9 ± 7.8 years). There were no differences in metatarsal lengths between the groups. However, those with midfoot OA had a higher calcaneal-first metatarsal angle (d = 0.43, small effect size, P = 0.018) and lower calcaneal inclination angle (d = 0.46, small effect size, P = 0.011) compared with controls. CONCLUSIONS: People with midfoot OA have a flatter foot posture compared with controls. Although caution is required when inferring causation from cross-sectional data, these findings are consistent with a pathomechanical pathway linking foot structure to the development of midfoot OA. Prospective studies are required to determine the temporal relationships between foot structure, function, and the development of this common and disabling condition.

Where is Your Pain? Achilles Tendinopathy Pain Location on Loading Is Different to Palpation, Imaging and Recall Location.

OBJECTIVE: To describe and compare pain maps reported during Achilles tendon loading exercises with recall pain location, in people with pain on palpation in their Achilles tendon and tendon pathology on imaging. DESIGN: Cross-sectional analysis of baseline RCT. METHOD: Participants were recruited from a larger Achilles tendinopathy clinical trial. Inclusion criteria were at least 2-month self-reported history of Achilles tendinopathy, midtendon palpation pain, and pathology on ultrasound tissue characterization. Participants were asked to identify their Achilles tendon pain location on a pain map with 8 prespecified locations while at rest prior to loading (recall pain), and subsequently during tendon loading exercises (loading pain). Participants could select multiple locations or select "other" if the locations did not represent their pain. RESULTS: Ninety-three participants were included (93% of participants from a clinical trial). The locations of pain on loading were diverse; all 8 pain locations (and an "other" option) were represented within this sample. Twenty-five percent of participants did not report pain with loading (n = 23 of 93). Of the 70 participants with loading pain, recall pain location differed to loading pain location in 40% (n = 28 of 70) of the participants. CONCLUSION: Palpation pain location, recall pain location, or location of pathology on imaging were not valid proxies for load-related pain in the Achilles tendon. How different pain locations respond to treatment is unknown. Some pathologies (eg, plantaris) have clear pain locations (eg, medial tendon), and assessing pain location may assist differential diagnosis. J Orthop Sports Phys Ther 2024;54(1):1-9. Epub 7 December 2023. doi:10.2519/jospt.2023.12131.