Dataset Information

Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Rheumatoid arthritis (RA) involves changes to foot structure and function, and there is an association between RA and foot pain. This pain affects those patient's physical activity and experience of daily living. While there is clinical evidence for the value of foot orthoses (FO) on foot pain, there is a wide range of FO available and there is little evidence on the relative benefits of one orthoses type over another, especially in terms of their impact on physical activity and associated well-being. The aim of this study is to compare physical activity, general and foot health and foot health experiences in people with RA when wearing three different types of FO. METHODS AND ANALYSIS:A randomised controlled trial with three arms will compare the effects of (1) custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses. The primary outcome is physical activity measured using a GENEActiv bracelet. Secondary outcomes will be pain, function and disability and associated foot and general health evaluated using existing questionnaires. Semistructured interviews will identify patients' experiences of the orthoses and living with RA. ETHICS AND DISSEMINATION:The study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee (SPAR-001). The results will be disseminated regardless of the magnitude or direction of effect. TRIAL REGISTRATION NUMBER:NCT03170947; Pre-results.

SUBMITTER: Ramos-Petersen L

PROVIDER: S-EPMC7371219 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial.

Ramos-Petersen Laura L Nester Christoper J CJ Gijon-Nogueron Gabriel G Ortega-Avila Ana Belen AB

BMJ open 20200719 7

<h4>Introduction</h4>Rheumatoid arthritis (RA) involves changes to foot structure and function, and there is an association between RA and foot pain. This pain affects those patient's physical activity and experience of daily living. While there is clinical evidence for the value of foot orthoses (FO) on foot pain, there is a wide range of FO available and there is little evidence on the relative benefits of one orthoses type over another, especially in terms of their impact on physical activity ...[more]

PMID: 32690521

Similar Datasets

Project description:BackgroundGuidelines recommend foot orthoses for people with both early (<?2?years) and established rheumatoid arthritis (RA). While prefabricated foot orthoses are cheaper and can exhibit comparable effects to customised devices, the available evidence for their effectiveness is inconsistent. Little is known about what types of foot orthoses clinicians prescribe. This study describes the foot orthoses prescription habits of podiatrists for people with rheumatoid arthritis.MethodsOne hundred and eighty-three podiatrists from the United Kingdom (UK) (n?=?88), Australia (n?=?68) and New Zealand (n?=?27) completed a self-administered, online survey regarding the types of foot orthoses prescribed in clinical practice for people with RA. This study forms part of a wider international survey exploring foot orthosis prescription habits.ResultsUK respondents were more likely to prescribe prefabricated orthoses for early RA (n?=?47, 53%) and customised orthoses for established RA (n?=?47, 53%). Respondents in Australia were more likely to prescribe customised orthoses for both early (n?=?32, 47%) and established (n?=?46, 68%) RA, whilst respondents in New Zealand were more likely to prescribe prefabricated orthoses for both early (n?=?16, 59%) and established (n?=?10, 37%) disease.Irrespective of disease stage, the use of foam impression boxes was more prevalent in the UK and New Zealand when capturing a model of the feet prior to manufacturing customised orthoses. In contrast, electronic scanning and plaster of Paris were more common in Australia. Computer aided manufacture was utilised more frequently among respondents in Australia than in the UK and New Zealand. Respondents in all three countries specified more flexible shell materials for established RA, compared to early disease. Cushioning top covers (e.g. PORON® or polyurethane) were most frequently specified in all countries for both disease stages.ConclusionsConsiderable variation was seen in the self-reported foot orthoses prescription habits of respondents for people with RA. Variation between countries and disease stage was seen in type of orthoses, specific brands, manufacturing methods, and materials prescribed. The results allow podiatrists and broader health service providers to compare their practice against reported national and international patterns.

Project description:BackgroundFoot orthoses (FOs) are prescribed as an important conservative treatment option in patients with foot problems related to rheumatoid arthritis. However, a broad variation in FOs is used, both in clinical practice and in research. To date, there is no overview on the outcomes of the treatment with different kinds of FOs in patients with rheumatoid arthritis and a specific foot problem. The objectives of the present study were to summarize the comparative effectiveness of FOs in the treatment of various foot problems in patients with rheumatoid arthritis, on the primary outcomes foot function and foot pain, and the secondary outcomes physical functioning, health related quality of life, compliance, adverse events, the costs of FOs and patient satisfaction.MethodsStudies comparing different kinds of FOs, with a presumed therapeutic effect, in the treatment of foot problems related to rheumatoid arthritis were included. A literature search was conducted in The Cochrane Central Registry for Controlled Trials (CENTRAL), PubMed, EMBASE and PEDro up to May 18th, 2018. Data was meta-analyzed, when this was not possible qualitative data analysis was performed.ResultsTen studies were identified, with a total number of 235 patients. These studies made a comparison between different materials used (soft versus semi-rigid), types of FOs (custom-made versus ready-made; total-contact versus non-total contact), or modifications applied (metatarsal bars versus domes). Also, different techniques to construct custom-made FOs were compared (standard custom-molding techniques versus more sophisticated techniques). A medium effect for (immediate) reduction of forefoot plantar pressure was found in favor of treatment with soft FOs compared to semi-rigid FOs (SMD 0.60, 95% CI 0.07-1.14; P = 0.03; 28 participants). Other comparisons between FOs resulted in non-significant effects or inconclusive evidence for one kind of FOs over the other.ConclusionsFoot orthoses made of soft materials may lead to more (immediate) forefoot plantar pressure reduction compared to foot orthoses constructed of semi-rigid materials. Definitive high quality RCTs, with adequate sample sizes and long-term follow-up, are needed to investigate the comparative (cost-) effectiveness of different kinds of foot orthoses for the treatment of foot problems related to rheumatoid arthritis.

Project description:BackgroundAchilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy.MethodsOne hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam) or an experimental group (customised foot orthoses made from semi-rigid polypropylene). Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire - Version two). Data will be collected at baseline, then at 1, 3, 6 and 12 months. Data will be analysed using the intention to treat principle.DiscussionThis study is the first randomised trial to evaluate the long-term efficacy of customised foot orthoses for the treatment of Achilles tendinopathy. The study has been pragmatically designed to ensure that the study findings are generalisable to clinical practice.Trial registrationAustralian New Zealand Clinical Trials Registry Number: ACTRN12609000829213.

Project description:BackgroundFoot problems in people with rheumatoid arthritis (RA) are highly prevalent and have a substantial impact on quality of life. Healthcare professionals from various professions can be involved in the management of these foot problems. There is currently no consensus on optimal management. Therefore, the aim of the present study was to develop multidisciplinary recommendations for the management of foot problems in people with RA in the Netherlands.MethodsThe recommendations were based on research evidence and consensus among experts, following published strategies for the development of practice recommendations. The expert group was composed of 2 patients and 22 experienced professionals (rheumatologists, rehabilitation physicians, orthopaedic surgeons, specialized nurses, podiatrists, orthopaedic shoe technicians, pedicurists, and researchers) in the Netherlands. For each developed recommendation i) the level of evidence was determined, and ii) the level of agreement (among the expert group) was set by an anonymous voting procedure using a numeric rating scale. The mean and range of the level of agreement for each recommendation was calculated. A recommendation was approved when ?70% of the expert group voted an NRS-agreement ?7.ResultsIn total, 41 recommendations were developed. Two recommendations concerned a framework for diagnosis and treatment. Thirty-nine recommendations on foot care were developed: seven on diagnosis (including check-ups of feet and shoes and diagnostic imaging), 27 on treatment (including corticosteroid injections, foot surgery, therapeutic shoes, foot orthoses, exercise therapy, toe-orthoses and toenail-braces, treatment of toenails and skin), four on communication, and one on organisation of RA-related footcare. All recommendations were approved by the expert group. The percentage score of NRS-agreement ?7 ranged from 80 to 100%.ConclusionsThese are the first published multidisciplinary recommendations specific to the management of foot problems in people with RA. Multidisciplinary recommendations can provide guidance in timely referrals and access to adequate footcare. More research is needed to strengthen the evidence on diagnosis and treatment of RA-related foot problems. These national recommendations may be a first step towards developing international multidisciplinary recommendations for the management of foot problems in RA.

Project description:ObjectiveTo compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.DesignProspective, single blind, randomised clinical trial.SettingSingle centre trial within a community setting in Brisbane, Australia.Participants179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks' duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.InterventionsSix weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.Main outcome measuresGlobal improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.ResultsFoot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66, 99% confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.ConclusionWhile foot orthoses are superior to flat inserts according to participants' overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.Trial registrationAustralian Clinical Trials Registry ACTRN012605000463673 and ClinicalTrials.gov NCT00118521.

Project description:IntroductionPatellofemoral (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 analysisThe 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 disseminationEthical 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 numberANZCTRN12617000385347; Pre-results.

Dataset Information

Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial.

Publications

Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets