Evaluating the Clinical Effectiveness and Cost-effectiveness of Foot Orthoses in the Treatment of Plantar Heel Pain

2004 ◽  
Vol 94 (3) ◽  
pp. 229-238 ◽  
Author(s):  
Keith Rome ◽  
Joanne Gray ◽  
Fiona Stewart ◽  
Stephen Charles Hannant ◽  
Des Callaghan ◽  
...  

This study evaluated the clinical effectiveness and cost-effectiveness of two different types of foot orthoses used to treat plantar heel pain. Forty-eight patients were randomly assigned to receive either a functional or an accommodative orthosis. General (EuroQol) and specific (Foot Health Status Questionnaire) health-status measures were used. Data were also collected using economic questionnaires relating to National Health Service costs for podia-try, other health-service costs, and patient costs. Data were measured at baseline and at 4- and 8-week intervals. Thirty-five patients completed the study. The results demonstrated a significant decrease in foot pain and a significant increase in foot function with the functional foot orthoses over the 8-week trial. The accommodative foot orthoses demonstrated a significant reduction in foot pain only at 4 weeks. The cost-effectiveness analysis demonstrated that functional orthoses, although initially more expensive, result in a better quality of life. Use of functional orthoses resulted in an increased cost of £17.99 ($32.74) per patient, leading to an incremental cost per quality-adjusted life year of £1,650 ($3,003) for functional orthoses. (J Am Podiatr Med Assoc 94(3): 229–238, 2004)

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Glen A. Whittaker ◽  
Karl B. Landorf ◽  
Shannon E. Munteanu ◽  
Hylton B. Menz

Abstract Background Foot orthoses and corticosteroid injection are common interventions used for plantar heel pain, however few studies have investigated the variables that predict response to these interventions. Methods Baseline variables (age, weight, height, body mass index (BMI), sex, education, foot pain, foot function, fear-avoidance beliefs and feelings, foot posture, weightbearing ankle dorsiflexion, plantar fascia thickness, and treatment preference) from a randomised trial in which participants received either foot orthoses or corticosteroid injection were used to predict change in the Foot Health Status Questionnaire foot pain and foot function subscales, and first-step pain measured using a visual analogue scale. Multivariable linear regression models were generated for different dependent variables (i.e. foot pain, foot function and first-step pain), for each intervention (i.e. foot orthoses and corticosteroid injection), and at different timepoints (i.e. weeks 4 and 12). Results For foot orthoses at week 4, greater ankle dorsiflexion with the knee extended predicted reduction in foot pain (adjusted R2 = 0.16, p = 0.034), and lower fear-avoidance beliefs and feelings predicted improvement in foot function (adjusted R2 = 0.43, p = 0.001). At week 12, lower BMI predicted reduction in foot pain (adjusted R2 = 0.33, p < 0.001), improvement in foot function (adjusted R2 = 0.37, p < 0.001) and reduction in first-step pain (adjusted R2 0.19, p = 0.011). For corticosteroid injection at week 4, there were no significant predictors for change in foot pain or foot function. At week 12, less weightbearing hours predicted reduction in foot pain (adjusted R2 = 0.25, p = 0.004) and lower baseline foot pain predicted improvement in foot function (adjusted R2 = 0.38, p < 0.001). Conclusions People with plantar heel pain who use foot orthoses experience reduced foot pain if they have greater ankle dorsiflexion and lower BMI, while they experience improved foot function if they have lower fear-avoidance beliefs and lower BMI. People who receive a corticosteroid injection experience reduced foot pain if they weightbear for fewer hours, while they experience improved foot function if they have less baseline foot pain.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Linda S. Chesterton ◽  
Martin J. Thomas ◽  
Gordon Hendry ◽  
Ying Chen ◽  
David Goddin ◽  
...  

Abstract Background Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. Methods This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. Results Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64–100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5–0.6, 0.4 and < 0.3, respectively. Conclusions We demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. Trial registration number ISRCTN 12160508. Prospectively registered 5th July 2016.


Pain Medicine ◽  
2019 ◽  
Vol 21 (5) ◽  
pp. 1032-1038 ◽  
Author(s):  
Ricardo Ortega-Santiago ◽  
Marta Ríos-León ◽  
Patricia Martín-Casas ◽  
César Fernández-de-las-Peñas ◽  
Gustavo Plaza-Manzano

Abstract Objective Pain experienced by patients with plantar heel pain has been associated with fascia thickness. It is possible that referred muscle pain may also be related to symptoms experienced by these patients. Our aim was to systematically investigate if the referred pain elicited by trigger points in the leg and foot musculature reproduces the symptoms in individuals with plantar heel pain and to determine the association of trigger points (TrPs) with pain and related disability. Methods A case–control study was conducted. Thirty-five individuals with unilateral chronic plantar heel pain and 35 matched comparable healthy controls participated. An assessor blinded to the subject’s condition explored TrPs in the flexor hallucis brevis, adductor hallucis, quadratus plantae, and internal gastrocnemius. Pain and related disability were assessed with a numerical pain rating scale (0–10), the Foot Function Index, and the Foot Health Status Questionnaire. Results The number of TrPs for each patient with plantar heel pain was 4 ± 3 (2.5 ± 2 active TrPs, 1.5 ± 1.8 latent TrPs). Healthy controls only had latent TrPs (mean = 1 ± 1). Active TrPs in the quadratus plantae (N = 20, 62.5%), and flexor hallucis brevis (N = 19, 59%) were the most prevalent in patients with plantar heel pain. A greater number of active, but not latent, TrPs was associated with higher foot pain variables (0.413 &lt; rs &lt; 0.561, P &lt; 0.01), higher impact of foot pain (0.350 &lt; rs &lt; 0.473, P &lt; 0.05) and worse related disability (–0.447 &lt; rs &lt; –0.35456, P &lt; 0.05). Conclusions The referred pain elicited by active TrPs in the foot muscles reproduced the symptoms in patients with plantar heel pain. A greater number of active TrPs was associated with higher pain and related disability in patients with plantar heel pain.


Author(s):  
Francisco Javier Domínguez-Muñoz ◽  
Miguel Angel Garcia-Gordillo ◽  
Rodrigo Anibal Diaz-Torres ◽  
Miguel Ángel Hernandez-Mocholi ◽  
Santos Villafaina ◽  
...  

Background and objectives: Type 2 Diabetes Mellitus (T2DM) is a chronic disease characterized by hyperglycemia. T2DM affects millions of people, and has a lot of complications such as impaired sensation in the feet. Moreover, it is important to know the health of the feet of people with T2DM. The aim of this study is to know the preliminary values of the Foot Health Status Questionnaire (FHSQ) in people with T2DM. Materials and Methods: A total of 87 patients with T2DM with an average age of 65.56 years, divided in 54 men and 33 women, participated in this cross-sectional study. The main outcome was the health of the foot as measured by the FHSQ questionnaire. This questionnaire collects data on eight dimensions: Foot Pain, Foot Function, Shoe, General Foot Health, General Health, Physical Activity, Social Capacity, and Vigor. Results: Patients with T2DM have lower values in Foot Pain; median values in General Foot Health and high values in Foot Function, Shoe, Physical Activity and Social Capacity. Some of these dimensions are affected by age, diabetes control, Body Mass Index (BMI), and years of diagnosis. Females with T2DM have more problems than males in the Shoe, General Foot Health, Physical Activity and Vigor dimensions. Conclusions: this research gives us preliminary values of the FHSQ in Spanish patients with T2DM and divided by gender, age, diabetes control, BMI, and years of diagnosis in people with T2DM.


2018 ◽  
Vol 52 (16) ◽  
pp. 1040-1046 ◽  
Author(s):  
Nadine Rasenberg ◽  
Henrik Riel ◽  
Michael S Rathleff ◽  
Sita M A Bierma-Zeinstra ◽  
Marienke van Middelkoop

BackgroundPlantar heel pain (PHP) is common. Foot orthoses are often applied as treatment for PHP, even though there is little evidence to support this.ObjectiveTo investigate the effects of different orthoses on pain, function and self-reported recovery in patients with PHP and compare them with other conservative interventions.DesignSystematic review and meta-analysis.Data sourcesA systematic literature search was conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL and Google Scholar up to January 2017.Eligibility criteria for selecting studiesRandomised controlled trials comparing foot orthoses with a control (defined as no intervention, sham or other type of conservative treatment) reporting on pain, function or self-reported recovery in patients with PHP.ResultsTwenty studies investigating eight different types of foot orthoses were included in the review. Most studies were of high quality. Pooled data from six studies showed no difference between prefabricated orthoses and sham orthoses for pain at short term (mean difference (MD) of 0.26 (95% CI −0.09 to 0.60)). No difference was found between sham orthoses and custom orthoses for pain at short term (MD 0.22 (95% CI −0.05 to 0.50)), nor was there a difference between prefabricated orthoses and custom orthoses for pain at short term (MD 0.03 (95% CI −0.15 to 0.22)). For the majority of other interventions, no significant differences were found.ConclusionsFoot orthoses are not superior for improving pain and function compared with sham or other conservative treatment in patients with PHP.PROSPERO registration numberCRD42015029659.


2019 ◽  
Vol 7 (22) ◽  
pp. 1-104 ◽  
Author(s):  
Matthew Maddocks ◽  
Lisa Jane Brighton ◽  
Morag Farquhar ◽  
Sara Booth ◽  
Sophie Miller ◽  
...  

Background Breathlessness is a common and distressing symptom of many advanced diseases, affecting around 2 million people in the UK. Breathlessness increases with disease progression and often becomes chronic or refractory. Breathlessness-triggered services that integrate holistic assessment and specialist palliative care input as part of a multiprofessional approach have been developed for this group, offering tailored interventions to support self-management and reduce distress. Objectives The aim was to synthesise evidence on holistic breathlessness services for people with advanced disease and chronic or refractory breathlessness. The objectives were to describe the structure, organisation and delivery of services, determine clinical effectiveness, cost-effectiveness and acceptability, identify predictors of treatment response, and elicit stakeholders’ evidence-based priorities for clinical practice, policy and research. Design The mixed-methods evidence synthesis comprised three components: (1) a systematic review to determine the clinical effectiveness, cost-effectiveness and acceptability of holistic breathlessness services; (2) a secondary analysis of pooled individual data from three trials to determine predictors of clinical response; and (3) a transparent expert consultation (TEC), comprising a stakeholder workshop and an online consensus survey, to identify stakeholders’ priorities. Results Thirty-seven papers reporting on 18 holistic breathlessness services were included in the systematic review. Most studies enrolled people with thoracic cancer, were delivered over 4–6 weeks, and included breathing training, relaxation techniques and psychological support. Meta-analysis demonstrated significant reductions in the Numeric Rating Scale (NRS) distress due to breathlessness, significant reductions in the Hospital Anxiety and Depressions Scale (HADS) depression scores, and non-significant reductions in the Chronic Respiratory Disease Questionnaire (CRQ) mastery and HADS anxiety, favouring the intervention. Recipients valued education, self-management interventions, and expertise of the staff in breathlessness and person-centred care. Evidence for cost-effectiveness was limited and inconclusive. The responder analysis (n = 259) revealed baseline CRQ mastery and NRS distress to be strong predictors of the response to breathlessness services assessed by these same measures, and no significant influence from baseline breathlessness intensity, patient diagnosis, lung function, health status, anxiety or depression. The TEC elicited 34 priorities from stakeholders. Seven priorities received high agreement and consensus, reflecting stakeholders’ (n = 74) views that services should be person-centred and multiprofessional, share their breathlessness management skills with others, and recognise the roles and support needs of informal carers. Limitations The evidence synthesis draws predominantly from UK services and may not be generalisable to other settings. Some meta-analyses were restricted by reporting biases and statistical heterogeneity. Conclusions Despite heterogeneity in composition and delivery, holistic breathlessness services are highly valued by recipients and can lead to significant improvements in the distress caused by breathlessness and depression. Outcomes of improved mastery and reduced distress caused by breathlessness are not influenced by patient diagnosis, lung function or health status. Stakeholders highlighted the need for improved access to person-centred, multiprofessional breathlessness services and support for informal carers. Future work Our research suggests that key therapeutic components of holistic breathlessness services be considered in clinical practice and models of delivery and educational strategies to address stakeholders’ priorities tested. Study registration This study is registered as PROSPERO CRD42017057508. Funding The National Institute for Health Research (NIHR) Health Services and Delivery programme. Matthew Maddocks, Wei Gao and Irene J Higginson are supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London; Matthew Maddocks is supported by a NIHR Career Development Fellowship (CDF-2017-009), William D-C Man is supported by the NIHR CLAHRC Northwest London and Irene J Higginson holds a NIHR Emeritus Senior Investigator Award.


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