Development and validation of a new questionnaire for the assessment of patients with diabetic foot disease: The Diabetic Foot Questionnaire (DiaFootQ).

BACKGROUND: The epidemiology data and global burden of diabetic foot disease underscores the need for effective prevention strategies, which requires an early diagnosis. Patient-reported outcome measures are instruments based on a simple format, which favours their application. Currently, there is an absence of instruments with a broad enough scope to capture the diverse aspects involved in diabetic foot disease. OBJECTIVES: To develop a questionnaire for the assessment of patients with diabetic foot disease and carry out an analysis of its validity and reliability. METHODS: The study was developed in two stages. Stage 1: the Delphi Panel was composed of 22 experts. The questionnaire is made up of 25 questions selected, after three rounds, from an initial sample of 68 questions. Stage 2: A validation study was performed. With a sample of 273 subjects, an exploratory factor analysis and an analysis of internal consistency, items response, and validity were carried out using the Diabetes Quality of Life, SF-12v2, Foot Function Index and EuroQol EQ5D questionnaires. Measurements of error and sensitivity to change were also analyzed. RESULTS: A 25-item questionnaire (DiaFootQ) was developed. It comprised two dimensions: 1) lifestyle and function; and 2) footwear and foot self-care. Sample (n=273) mean age was 69.77 years (±11.08). The internal consistency of DiafootQ was α=0.916, and item response values were ICC=0.862-0.998. External validity correlation levels ranged from r=0.386 to r=0.888. CONCLUSION: DiaFootQ was developed. Integrating the main aspects involved in diabetic foot disease could help to detect more accurately the risk or severity of these patients. DiaFootQ is a well-structured, valid, and reliable tool whose use should be promoted in clinical and research settings.

Preventing Diabetic Foot Re-Ulceration Through an Innovative Pressure and Temperature Monitoring Clinical Device.

This study compared the outcome of an innovative in-shoe pressure and temperature measuring device as an adjunct to standard clinical care for diabetic foot versus standard clinical care alone. It included 88 participants with Type 2 diabetes mellitus with a history of one or more plantar foot ulceration who were already using prescription orthoses. These were randomly divided into the control group (n = 44, standard care only) and the experimental group (n = 44, standard care plus the innovative device). Both groups were monitored for re-ulceration for one year. Overall, the control group exhibited a higher number of re-ulcerations (n = 14) with 2 amputations in comparison with the experimental group (only 2 ulcerations and no amputations) at the end of the study. In conclusion, this innovative in-shoe pressure and temperature measuring device appears to reduce re-ulcerations by offering objective data for clinical decision making in the management of the diabetic high-risk foot.

Diabetic Foot Screening Guidelines and the Role of Artificial Intelligence: Time to Turn the Tide!

Despite medical and technological advancements, foot amputations continue to rise. Thus, the effort of diabetic foot management should be toward prevention and early diagnosis. Healthcare professionals need to be trained, equipped, and supported with adequate resources to be able to identify and deliver appropriate foot care. Every effort should be made to minimize the impact of complications and to ensure prompt access to care for everyone. Artificial intelligence and smart technology could provide a significant opportunity to improve efficiency in diabetes care, which may reduce diabetic foot complications. The possible potential of the new technologies which are emerging together with their current developing applications for diabetic foot care are suggested. A call for immediate change in diabetes foot screening guidelines is imperative to save limbs and lives.

The Traffic Light System: A user-friendly alternative for gait data representation.

BACKGROUND: Instrumented gait analysis is an established procedure in biomechanical assessment, requiring specially-trained analysts to interpret the complex graphical output generated. RESEARCH QUESTION: Does a new method of visual representation of lower limb kinematic gait analysis data provide a reliable and valid method of interpretation of biomechanical data for healthcare professionals? METHODS: An innovative system based on the Traffic Lights System (TLS) was developed. Simulated abnormal gait was captured using a 16-camera optoelectronic motion capture system, and the results were presented in both the Traditional Graphical System (TGS) format and the new TLS. An online form was filled by health professionals who attempted to interpret normal and abnormal motion in the joints presented in the 2 output formats. RESULTS: Out of 26 raters, 18 preferred the new system because of its user-friendliness and its ease of interpretation. 2 raters preferred the TGS, with one of these raters clarifying that the preference is due to colour blindness. For intra-rater reliability, 2 trained raters provided a second response for the TGS (Cronbach's Alpha ranging between 0.733 and 0.918), whilst the TLS resulted in Cronbach's Alpha between 0.817 and 1.00 amongst 3 untrained raters. The Fleiss Multi-rater Kappa Test demonstrated low inter-rater reliability amongst raters in the TGS, whereas the overall Fleiss Multi-rater Kappa values of the TLS surpassed the TGS in all 3 studies. SIGNIFICANCE: This study showed that whilst trained health professionals have high intra-rater reliability in interpreting traditional gait analysis results, those professionals inexperienced in the system, do not always comprehend the complex graphs generated by the system when presenting gait analysis data. When these graphs are transformed into coloured outputs representing the extent of the movement, the TLS has demonstrated high validity and high intra- and inter-rater reliability, significantly exceeding those of the TGS, especially in untrained health professionals.

Digital Foot Technology in Ulcer Prevention and Reulceration: A Clinical Perspective.

BACKGROUND: Studies have shown that personal and economic reasons determine whether clinicians use diagnostic technology in their routine clinical biomechanical practice. This study aimed to identify the biomechanical management plan of local clinicians in relation to management of the diabetic high-risk foot and to investigate whether diagnostic technology is being used to determine the effectiveness of dispensed prescription orthoses in view of ulcer prevention. METHODS: A mixed-methodologic approach was adopted in this study. A retrospective quantitative study was also conducted to access records of patients attending the biomechanics clinic at a local health biomechanics clinic. Outcomes of interest included the number and percentage of patients attending the biomechanics clinic, source of referral to this clinic, age and gender of patients, clinical diagnosis, management plan, and referral pathway. Following a phenomenologic approach, four experienced clinicians working in the private, primary, and tertiary health sectors were interviewed. Thematic analysis was used to analyze and interpret data. RESULTS: Only low-risk patients living with diabetes mellitus were referred for a comprehensive biomechanical examination; the majority were referred by podiatrists. There was no record of diabetic high-risk patients being referred for a detailed biomechanical assessment within the health service. This study also confirmed that, because of the expenses and laborious work involved when using diagnostic technology to assess foot pressures, interviewed clinicians based their treatment plan and tested the efficiency of dispensed offloading devices on the basis of clinical experience and visual observation only. CONCLUSIONS: Waiting for signs of ulceration can be too late for the high-risk foot. A change in clinical practice is recommended where the integration of diagnostic technology, together with standard care, in view of ulcer prevention is warranted.

Considerations for a Sustainable Podiatric Telemedicine Service.

Presently telemedicine in podiatry is in its nascent development phase. Current exploratory work indicates that a comprehensive set of guidelines regarding telemedicine in podiatry is necessary. Stakeholders have put forward multiple factors to be considered while developing guidelines to devise a sustainable service.

Effective and clinically relevant optimisation of cushioning stiffness to maximise the offloading capacity of diabetic footwear.

INTRODUCTION: Optimising the cushioning stiffness of diabetic footwear/orthoses can significantly enhance their offloading capacity. This study explores whether optimum cushioning stiffness can be predicted using simple demographic and anthropometric parameters. METHODS: Sixty-nine adults with diabetes and loss of protective sensation in their feet were recruited for this cross-sectional observational study. In-shoe plantar pressure was measured using Pedar® for a neutral diabetic shoe (baseline) and after adding cushioning footbeds of varying stiffness. The cushioning stiffness that achieved maximum offloading was identified for each participant. The link between optimum cushioning stiffness and plantar loading or demographic/anthropometric parameters was assessed using multinomial regression. RESULTS: People with higher baseline plantar loading required stiffer cushioning materials for maximum offloading. Using sex, age, weight, height, and shoe-size as covariates correctly predicted the cushioning stiffness that minimised peak pressure across the entire foot, or specifically in the metatarsal heads, midfoot and heel regions in 70%, 72%, 83% and 66% of participants respectively. CONCLUSIONS: Increased plantar loading is associated with the need for stiffer cushioning materials for maximum offloading. Patient-specific optimum cushioning stiffness can be predicted using five simple demographic/anthropometric parameters. These results open the way for methods to optimise cushioning stiffness as part of clinical practice.

Innovative single-sensor, in-shoe pressure and temperature monitoring device: A static laboratory validation study.

BACKGROUND: To perform laboratory static validation of pressures from an innovative, single-sensor pressure and temperature monitoring device for the early detection of complications in the high-risk foot. RESEARCH QUESTION: Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature as accurately as the reference standard? METHODS: A pressure generating rig, the Tekscan™ Equilibration 'bladder calibrator', was used to produce a known force, against the gold standard, FScan™ in-shoe pressure mapping system by Tekscan™ and a newly developed prototype. The F-scan® system was used to record the pressure readings and establish a baseline for the readings recorded utilising the prototype. A total of 20 pressure values were recorded with 100 samples each. RESULTS: Exploratory data analysis was conducted to gain insights and analyse the prototype's behaviour at different pressure points. Pre-processing and data cleaning were also performed to remove any anomalies. Support Vector Regressor with a polynomial kernel and Grid-Search algorithm was used to fit the recorded data curve. The best combination of parameters had a Mean Squared Error of 2.59 and a Root Mean Squared Error of 1.61. A simple linear equation was used to convert raw readings to pressure values. SIGNIFICANCE: The results of this study conclude that the pressure measurements taken with the prototype are congruent to the gold standard, F-scan® in-shoe system. This confirms that the prototype is a valid device that can be used safely as a low-cost alternative to current costly commercial in-shoe pressure mapping devices.

The Kinematics of Fixed-Seat Rowing: A Structured Synthesis.

Olympic-style sliding-seat rowing is a sport that has been extensively researched, with studies investigating aspects related to the physiology, biomechanics, kinematics, and the performance of rowers. In contrast, studies on the more classic form of fixed-seat rowing are sparse. The aim of this study is to address this lacuna by analysing for the first time the specific kinematics of fixed-seat rowing as practised by able-bodied athletes, thus (i) documenting how this technique is performed in a manner that is replicable by others and (ii) showing how this technique compares and contrasts with the more standard sliding-seat technique. Fixed-seat rowing was replicated in a biomechanics laboratory where experienced fixed-seat rowers, marked with reflective markers following the modified Helen-Hayes model, were asked to row in a manner that mimics rowing on a fixed-seat boat. The findings from this study, complimented with data gathered through the observation of athletes rowing on water, were compared to sliding-seat ergometer rowing and other control experiments. The results show that, in fixed-seat rowing, there is more forward and backward thoracic movement than in sliding-seat rowing (75-77° vs. 44-52°, p < 0.0005). Tilting of the upper body stems was noted to result from rotations around the pelvis, as in sliding-seat rowing, rather than from spinal movements. The results also confirmed knee flexion in fixed-seat rowing with a range of motion of 30-35°. This is less pronounced than in standard-seat rowing, but not insignificant. These findings provide a biomechanical explanation as to why fixed-seat rowers do not have an increased risk of back injuries when compared with their sliding-seat counterparts. They also provide athletes, coaches, and related personnel with precise and detailed information of how fixed-seat rowing is performed so that they may formulate better and more specific evidence-based training programs to meliorate technique and performance.

Mental Health Status and Quality of Life in Lower-Limb Amputees With Diabetes.

AIM: To compare mental health status and quality of life in lower-limb amputees versus nonamputees among participants with diabetes mellitus. METHODS: We included 38 participants with prior minor amputation (group 1) and 38 participants without amputation /history of amputation (group 2). These were interviewed twice using 2 questionnaires to screen for mental health status and quality of life (Self Reporting Questionnaire 20-SRQ20 and EQ-5D-5L). Interviews were carried out 1 week and 6 months after amputation. RESULTS: The mean SRQ20 score for group 1 at 1 week postamputation was 8.50 (diagnostic of a mental health disorder), while it was 1.34 for group 2. At 6 months, mean SRQ20 for group 1 decreased to 5.42, indicating a decrease in psychological distress. A significant difference in the mean values for each dimension of the EQ-5D-5L between groups 1 and 2 indicated that amputees had a poorer quality of life at 1 week and at 6 months. CONCLUSION: Mental health and quality of life are negatively affected at 1 week after minor lower-limb amputation in diabetes. At 6 months, some improvement in mental health distress was seen, indicating that these individuals had adapted to the disability.

Diabetic Amputations in 2023 are Still More Frightening Than Death-Act Now Before it is Too Late.

Despite huge medical and technological advances to date for the diagnosis, monitoring, and management of diabetic foot complications, their prevalence is still alarmingly high. Patients' quality of life may be severely compromised. Patients may fear amputations more than death. An effort to minimize the impact of these complications and to ensure prompt access to care for everyone is still required. Urgent therapeutic measures should become possible when needed. Improved physician training in and management of peripheral arterial disease are also vital. We need to act now before it is too late. This will definitely be one of the greatest challenges for 2023 and the years to come.

Effectiveness of Iontophoresis in Treating Plantar Hyperhidrosis.

BACKGROUND: The purpose of this study was to evaluate the effectiveness of tap water iontophoresis as a treatment for plantar hyperhidrosis. METHODS: Thirty participants living with idiopathic plantar hyperhidrosis and consented to undergo treatment using iontophoresis were recruited. The Hyperhidrosis Disease Severity Score was used to evaluate the severity of the condition before and after treatment. RESULTS: Tap water iontophoresis was found to be effective in the treatment of plantar hyperhidrosis in the study group (P = .005). CONCLUSIONS: Treatment with iontophoresis led to the reduction of disease severity and improvement of quality of life, and it is a safe, easy-to-use method with minimal side effects. This technique should be considered before the use of systemic or aggressive surgical interventions, which could have potentially more severe side effects.

On the Kinematics of the Forward-Facing Venetian-Style Rowing Technique.

This work presents a qualitative and quantitative pilot study which explores the kinematics of Venetian style forward-facing standing rowing as practised by able-bodied competitive athletes. The technique, made famous by the gondoliers, was replicated in a biomechanics laboratory by a cohort of four experienced rowers who compete in this style at National Level events in Malta. Athletes were marked with reflective markers following the modified Helen Hayes model and asked to row in a manner which mimics their on-water practise and recorded using a Vicon optoelectronic motion capture system. Data collected were compared to its equivalent using a standard sliding-seat ergometer as well as data collated from observations of athletes rowing on water, thus permitting the documentation of the manner of how this technique is performed. It was shown that this rowing style is characterised by rather asymmetric and complex kinematics, particularly upper-body movements which provides the athlete with a total-body workout involving all major muscle groups working either isometrically, to provide stability, or actively.

A scoping review of foot and ankle telemedicine guidelines.

Background and Aims: The COVID-19 pandemic accelerated the adoption of telemedicine in general. Its use has been widely adopted in the healthcare sector, but relatively little research has been conducted on the use of telemedicine for podiatry. This review aimed to explore and compare existing guidelines on telemedicine related to foot and ankle pathologies within a primary care setting. Methods: The preferred reporting guidelines for the extension of scoping reviews were used in this review, and a set of inclusion and exclusion criteria were developed and implemented. This study made use of both databases and gray literature searches. Between 2012 and 2022, these databases were searched using various subject headings and free-text terms for the keywords "telemedicine" "foot health" and "guidelines" with appropriate Boolean operators. Results: The search yielded 356 articles, which were reduced to 283 after removing duplicates. Six more records were discovered through a Google and Google Scholar search and one through an article reference search. Six articles and three institutional practice guidelines were selected for synthesis after screening. The findings were classified according to the level of evidence and research quality, the function of telemedicine and the communication used, the research outcomes sought, and the type of recommendations and guidelines made available. Conclusion: This review highlights the lack of podiatric telemedicine guidelines for foot and ankle pathologies. Although foot and ankle guidelines for orthopedic and musculoskeletal virtual consultations have been mentioned, they do not cover the full range of potential case scenarios that fall within the remit of podiatric consultations in a primary care setting. This review suggests the development of foot and ankle telemedicine guidelines with recommendations on how they can better provide accessible care to their patients, making foot and ankle care management not only a hand-on-one but also reachable virtually, where applicable.

Innovative single-sensor, in-shoe pressure and temperature monitoring device: A dynamic laboratory validation study.

BACKGROUND: Available technology to detect the 2 primary predictors of ulceration is not being used as it is deemed as costly and time-consuming. Thus, the aim of this study was to determine dynamic laboratory validation, of an innovative, single-sensor in-shoe device that can read peak pressure and temperature simultaneously. RESEARCH QUESTION: Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature of healthy participants, as accurately as the reference standard? METHODS: Five healthy adult participants were recruited. The prototype was validated against the gold standard FScan™ in-shoe system for pressures and the Flir® T630sc thermographic camera for temperatures. Participants were asked to walk at a comfortable pace on an electric treadmill for 13 min. The prototype and the FScan in-shoe sensors™ were superimposed inside the shoe of the participant, with the prototype on top, to ensure direct contact with the area of interest. Two thermographic images were captured using the Flir® T630sc thermographic camera, before and after the walk. During the trials, the participants wore 100 % cotton socks and their own sports shoes and pressures were recorded at 50 readings a second. RESULTS: The raw readings of pressure were passed to the regressor, which returned the estimated kPa value. Several evaluations metrics were used to evaluate the performance of the modal. The prototype gave equal results to that of the gold standard, the FScan™ in-shoe system. With regards to temperature measurements, both devices gave similar readings. SIGNIFICANCE: This innovative single-sensor, in-shoe pressure and temperature monitoring device showed similar measurements of pressure to the FScan™ system and temperature measurements were equivalent to the Flir® T630sc thermographic camera. The authors are confident that the innovative, low cost, single-sensor, in-shoe pressure and temperature monitoring device can be used as an alternative to the costly available commercial devices that measure pressure and temperature separately to detect early signs of complications in the high-risk foot.

Validity and reliability of the English version of the Diabetic Foot Self-Care Questionnaire: a cross-cultural adaptation.

Introduction: The objective of this study was to carry out the cross-cultural adaptation and validation of the Diabetic Foot Self-Care Questionnaire into the English language, broadening the applicability of this patient-reported outcome measure and improving the monitoring of patients with diabetic foot disease. Methods: The validation study into English was conducted in two phases: cross-cultural adaptation and psychometric validation study. Short Form-12 Version 2, EuroQoL-5D and Foot Function Index were used to analyze the criterion validity. Item response, internal consistency, standard error of measurement, minimal detectable change and construct validity were calculated in the validation phase. Results: An English version of the questionnaire (DFSQ-UMA-En) was successfully obtained. A total of n = 193 participants were tested to confirm the validity and reliability of the questionnaire. Internal consistency values ranged from very good to excellent (Cronbach's α =0.889-0.981), and reliability was excellent (ICC = 0.854-0.959). Standard error measurement value was =2.543. Criterion validity ranged from r = 0.429 to r = 0.844. For construct validity, Kaiser-Meyer-Olkin test was =0.752. Conclusion: DFSQ-UMA-En is a valid and reliable tool with good readability and comprehension features. This questionnaire addresses foot self-care behaviors in patients with diabetic foot disease, standing out as essential for early diagnosis and prevention strategies in clinical and research settings.

A Biomechanical Investigation of Children with Type 1 Diabetes Mellitus: Are Children's Feet a Precursor to Adulthood Foot Complications?

BACKGROUND: There is limited evidence on the biomechanical effects of type 1 diabetes mellitus (T1DM) on children's feet. This study aimed to determine whether children living with T1DM aged 10 to 16 years have altered foot structure and gait parameters compared with same-aged children without medical conditions. METHODS: A nonexperimental, case-control study was conducted. Thirty-four healthy children and children living with T1DM were recruited. Participants underwent a clinical biomechanical examination followed by instrumented gait analysis using the Oxford Foot Model to investigate foot segment motion. RESULTS: Children with T1DM demonstrated more dermatologic lesions and structural foot abnormalities, including claw toes (33.3%), hammertoes (22.2%), and hallux abducto valgus (11.1%), than their healthy counterparts. Gait analysis results indicate a significant difference between the two groups at the hindfoot-to-tibia angle at heel strike and toe-off, suggesting limited ankle joint motion. CONCLUSIONS: Children with T1DM demonstrated a higher frequency of structural foot pathologies than did healthy children possibly associated with limited ankle sagittal plane movement. Screening is warranted to identify and manage these conditions early to reduce their risk of more significant foot problems associated with DM in adulthood.

The Impact of Diabetes in Intermittent Claudication: A Prospective Cohort Study.

The aim of this study was to determine the lower-limb outcome in patients with intermittent claudication (IC) and to identify predictors for deterioration. This study employed a prospective observational cohort single-centre design. One hundred fifty patients with IC attending a vascular surgery unit for the first time were recruited. Lower limb perfusion was assessed utilising ankle brachial index (ABI) measures, toe-brachial index (TBI) measures, Doppler waveform analysis and the walking impairment questionnaire. Follow-up was conducted after 1 year and 2 years following recruitment to assess haemodynamic parameters, symptom severity and outcome. Recruited participants had a mean age of 69.7 (±9.3) years, BMI 27.8(±4.2) and 79.3% were men. Significant haemodynamic decline (decline in ABPI by ≥0.15 and/or decline in TBPI by ≥0.1) occurred in 50.6% of the cohort within 2 years of whom 23.3% developed chronic limb threatening ischaemia (CLTI) with rest pain and/or tissue loss. Baseline ABPI, ABPI ≤ 0.5, TBPI ≤ 0.39, infrapopliteal artery (IPA) disease and high Haemoglobin A1c were identified as significant predictors for deterioration to CLI. (P < .05, binomial logistic regression). Patients with IC are at a high risk of developing CLTI within 2 years. Risk of lower limb adverse events is tripled in patients with IPA disease, low ankle and toe pressures and poorly controlled diabetes. Early identification of those at high risk for early deterioration may justify a paradigm shift in the management of this subgroup.

Conservative Approach in the Management of Lesser Toe Deformities in Older Adults.

BACKGROUND: Toe deformities are common foot abnormalities in older adults, contributing to functional disability, loss of balance, falls, and pressure lesions. The aim of this study was to evaluate the effectiveness of the custom-made molded silicone toe prop in distributing apical and metatarsophalangeal joint peak plantar pressures and force-time integral in toe deformities, including hammertoes and claw toes, and to observe any difference in pressures between flexible and rigid toe deformities. METHODS: A prospective quasi-experimental pretest/posttest study was conducted including 20 "healthy" older adults with a hammer or claw toe at the second digit. Ten subjects presented with a flexible toe and 10 subjects presented with a rigid toe. A molded silicone toe prop was devised for each participant. Dynamic plantar pressure measurements were taken/recorded before applying the toe prop and after the toe prop was placed under the toe. RESULTS: Significant differences in mean peak plantar pressure and pressure-time integral were observed at the apex of the second toe in both the flexible and rigid toe deformity when using a molded silicone toe prop. At the metatarsophalangeal joint, pressures were significantly reduced in the rigid toe deformity but not in the flexible toe deformity. CONCLUSIONS: Silicone molded toe props were found to be effective in reducing peak pressure and pressure-time integral on the apex of the second digit in participants with both flexible and rigid claw or hammertoe deformity. Lesser toe deformities may be the cause of several foot complications, including pain on walking, corns, difficulty in wearing footwear, possible ulcerations caused by increased pressure at the apices of the toes, and other comorbidities, that could possibly lead to falls in older adults and thus need to be addressed appropriately.

The Management of Metatarsalgia in Rheumatoid Arthritis Using Simple Insoles: An Effective Concurrent Treatment to Drug Therapy.

BACKGROUND: Metatarsalgia is a common affliction in rheumatoid arthritis (RA), often requiring aggressive pharmacologic treatment that carries associated adverse effects. The aim of this study was to investigate whether simple insoles would have a beneficial effect on forefoot pain, disability, and functional limitation in participants with RA experiencing forefoot pain. METHOD: A prospective, quasi-experimental, pretest-posttest trial was performed at a rheumatology outpatient clinic. Participants were supplied with a simple insole comprising a valgus pad and a plantar metatarsal pad and covered with a cushioning material. The Foot Function Index (FFI) was self-administered before and 3 months after insole use. RESULTS: Reductions in forefoot pain (from 56.78 to 42.97) and total (from 41.64 to 33.54) FFI scores were noted. Statistical significance for this reduction was achieved following the t test (P = .002 and P = .0085, respectively). However, although reductions in mean disability and activity limitation scores were recorded (from 50 to 44.85 and from 18 to 14.57, respectively), these did not reach significance (P = .151 and P = .092, respectively) Conclusions: Simple insoles have been shown to be effective in reducing total and forefoot pain FFI scores in patients with RA experiencing metatarsalgia. This treatment offers advantages because these devices can be fabricated simply and cheaply, thus initiating the patient on an effective orthosis therapy immediately in the clinic without having to wait for prolonged periods until custom orthotic devices can be supplied.