Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Collins NJ

PROVIDER: S-EPMC6500302 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Collins Natalie J NJ Tan Jade M JM Menz Hylton B HB Russell Trevor G TG Smith Anne J AJ Vicenzino Bill B Munteanu Shannon E SE Hinman Rana S RS Haines Terry P TP Hart Harvi F HF Patterson Brooke E BE Cleary Gearoid G Donnar Joel W JW Maclachlan Liam R LR Crossley Kay M KM

BMJ open 20190420 4

<h4>Introduction</h4>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 effi ...[more]

PMID: 31005917

Similar Datasets

Project description:BackgroundPatellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence-based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient-perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP.MethodsThis randomised, controlled, participant- and assessor-blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12-18 years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3 months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop-out rate. Secondary outcomes will evaluate knee-related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions, at 6 weeks and 3 months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between-group differences (with 95% confidence intervals) will be reported for secondary outcomes.DiscussionFindings of this study will inform the feasibility of a full-scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full-scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population.Trial registrationACTRN12619000957190 .

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:BackgroundPatellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy.Methods/designA randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18-40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.DiscussionThe randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions.Trial registrationAustralian Clinical Trials Registry ACTRN012605000463673ClinicalTrials.gov NCT00118521.

Project description:BackgroundElevated patellofemoral joint stress has been associated with patellofemoral osteoarthritis (PFOA). Changes in lower limb kinematics, such as excessive femoral adduction and internal rotation and excessive rearfoot eversion during the stance phase of functional activities, may increase patellofemoral stress. There is a lack of studies that assess the effects of interventions for controlling femur and subtalar joint movements during functional activities on self-reported measures in individuals with PFOA. Thus, the primary aim of the study is to determine the immediate effects of the hip strap and foot orthoses during level-ground walking and the single-leg squat test on self-reported outcomes. The secondary aim is to investigate whether the hip strap and foot orthoses result in the kinematic changes that these devices are purported to cause.MethodsTwenty-nine individuals with PFOA aged 50 years or older will take part in the study. The main outcome is pain intensity. The secondary outcomes are other self-reported measures (global rating of change, acceptable state of symptoms, ease of performance, and confidence) and lower limb kinematics (peak femoral adduction and internal rotation, and peak rearfoot eversion). These outcomes will be assessed during functional tasks performed under three conditions: (i) control condition, (ii) hip strap intervention, and (iii) foot orthoses intervention. To investigate whether these interventions result in the lower limb kinematic changes that they are purported to cause, three-dimensional kinematics of the femur and rearfoot will be captured during each task. Linear mixed models with two fixed factors will be used to test associations between the interventions (control, hip strap, and foot orthoses) and conditions (level-ground walking and single-leg squat test) as well as interactions between the interventions and conditions.DiscussionTo the best of the authors' knowledge, this is the first study to evaluate the immediate effects of the hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with PFOA. The findings of this study will enable future trials to investigate the effects of these interventions in rehabilitation programmes.Trial registrationClinicalTrials.gov NCT04332900 . Registered on 3 April 2020.

Project description:IntroductionThe aim of this randomised feasibility trial is to determine the feasibility of conducting an adequately powered randomised controlled trial (RCT) investigating the efficacy of prefabricated contoured foot orthoses in people with hip osteoarthritis (OA). The secondary aims of the trial are to compare the effect of prefabricated contoured foot orthoses to a flat shoe insert comparator on outcomes of hip-related pain, physical activity and quality of life. We hypothesise that the demand, implementation, acceptability and practicality of foot orthoses as a treatment option for people with hip OA will be deemed feasible, informing the development of an adequately powered RCT to evaluate the efficacy and long term outcomes.Methods and analysisWe will recruit 28 people with hip OA who will be randomised to receive either prefabricated contoured foot orthoses or flat shoe inserts to use for a 6-week period. Both groups will receive standardised education on hip OA and physical activity. The study's primary outcome is the feasibility domains of demand, implementation, acceptability and practicality. The secondary outcomes include the change in Hip Osteoarthritis Outcome Score-12, Patient Health Questionnaire-9, Brief Fear of Movement Scale for OA, Physical activity accelerometry and the Physical Activity Questionnaire-short form. Descriptive statistics will be used to describe feasibility outcomes with limited efficacy analysis used for the secondary outcomes. Linear mixed models will be used to analyse between-group differences at 6 weeks, with baseline values used as covariates, treatment allocation as a fixed factor and participant as a random factor.Ethics and disseminationThis trial has been approved by the La Trobe University Human Research Ethics Committee (HEC20427), St. Vincent's Hospital Melbourne, Human Research Ethics Committee (HREC 266/20) and Northern Health Research Governance (NH-2021-292862). The results will be disseminated via a peer-reviewed journal and presented at international conferences.Trial registration numberNCT05138380.

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets