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      Effectiveness of Foot Orthoses Versus Rocker‐Sole Footwear for First Metatarsophalangeal Joint Osteoarthritis: Randomized Trial

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          Abstract

          Objective

          To compare the effectiveness of prefabricated foot orthoses to rocker‐sole footwear in reducing foot pain in people with first metatarsophalangeal (MTP) joint osteoarthritis (OA).

          Methods

          Participants (n = 102) with first MTP joint OA were randomly allocated to receive individualized, prefabricated foot orthoses or rocker‐sole footwear. The primary outcome measure was the pain subscale on the Foot Health Status Questionnaire (FHSQ) at 12 weeks. Secondary outcome measures included the function, footwear, and general foot health subscales of the FHSQ; the Foot Function Index; severity of pain and stiffness at the first MTP joint; perception of global improvement; general health status; use of rescue medication and co‐interventions to relieve pain; physical activity; and the frequency of self‐reported adverse events.

          Results

          The FHSQ pain subscale scores improved in both groups, but no statistically significant difference between the groups was observed (adjusted mean difference 2.05 points, 95% confidence interval [95% CI] −3.61, 7.71; P = 0.477). However, the footwear group exhibited lower adherence (mean ± SD total hours worn 287 ± 193 versus 448 ± 234; P < 0.001), were less likely to report global improvement in symptoms (39% versus 62%; relative risk [RR] 0.63, 95% CI 0.41, 0.99; P = 0.043), and were more likely to experience adverse events (39% versus 16%; RR 2.47, 95% CI 1.12, 5.44; P = 0.024) compared to the orthoses group.

          Conclusion

          Prefabricated foot orthoses and rocker‐sole footwear are similarly effective at reducing foot pain in people with first MTP joint OA. However, prefabricated foot orthoses may be the intervention of choice due to greater adherence and fewer associated adverse events.

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          Most cited references33

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          Statistics notes: Analysing controlled trials with baseline and follow up measurements.

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            Analysis of serial measurements in medical research.

            In medical research data are often collected serially on subjects. The statistical analysis of such data is often inadequate in two ways: it may fail to settle clinically relevant questions and it may be statistically invalid. A commonly used method which compares groups at a series of time points, possibly with t tests, is flawed on both counts. There may, however, be a remedy, which takes the form of a two stage method that uses summary measures. In the first stage a suitable summary of the response in an individual, such as a rate of change or an area under a curve, is identified and calculated for each subject. In the second stage these summary measures are analysed by simple statistical techniques as though they were raw data. The method is statistically valid and likely to be more relevant to the study questions. If this method is borne in mind when the experiment is being planned it should promote studies with enough subjects and sufficient observations at critical times to enable useful conclusions to be drawn. Use of summary measures to analyse serial measurements, though not new, is potentially a useful and simple tool in medical research.
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              Normative values for the Foot Posture Index

              Background The Foot Posture Index (FPI) is a validated method for quantifying standing foot posture, and is being used in a variety of clinical settings. There have however, been no normative data available to date for comparison and reference. This study aimed to establish normative FPI reference values. Methods Studies reporting FPI data were identified by searching online databases. Nine authors contributed anonymised versions of their original datasets comprising 1648 individual observations. The datasets included information relating to centre, age, gender, pathology (if relevant), FPI scores and body mass index (BMI) where available. FPI total scores were transformed to interval logit scores as per the Rasch model and normal ranges were defined. Comparisons between groups employed t-tests or ANOVA models as appropriate and data were explored descriptively and graphically. Results The main analysis based on a normal healthy population (n = 619) confirmed that a slightly pronated foot posture is the normal position at rest (mean back transformed FPI raw score = +4). A 'U' shaped relationship existed for age, with minors and older adults exhibiting significantly higher FPI scores than the general adult population (F = 51.07, p < 0.001). There was no difference between the FPI scores of males and females (2.3 versus 2.5; t = -1.44, p = 0.149). No relationship was found between the FPI and BMI. Systematic differences from the adult normals were confirmed in patients with neurogenic and idiopathic cavus (F = 216.981, p < 0.001), indicating some sensitivity of the instrument to detect a posturally pathological population. Conclusion A set of population norms for children, adults and older people have been derived from a large sample. Foot posture is related to age and the presence of pathology, but not influenced by gender or BMI. The normative values identified may assist in classifying foot type for the purpose of research and clinical decision making.
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                Author and article information

                Journal
                Arthritis Care Res (Hoboken)
                Arthritis Care Res (Hoboken)
                10.1002/(ISSN)2151-4658
                ACR
                Arthritis Care & Research
                John Wiley and Sons Inc. (Hoboken )
                2151-464X
                2151-4658
                27 April 2016
                May 2016
                : 68
                : 5 ( doiID: 10.1002/acr.v68.5 )
                : 581-589
                Affiliations
                [ 1 ]La Trobe University, Bundoora VictoriaAustralia
                [ 2 ]La Trobe University, Bundoora, Victoria, Australia, and Victoria University Melbourne VictoriaAustralia
                [ 3 ]Keele University StaffordshireUK
                Author notes
                [*] [* ]Address correspondence to Hylton B. Menz, PhD, School of Allied Health, College of Science, Health and Engineering, La Trobe University, Bundoora, Victoria 3086, Australia. E‐mail: h.menz@ 123456latrobe.edu.au .
                Article
                ACR22750
                10.1002/acr.22750
                5074253
                26638878
                3858a9a8-eca9-4dd0-bd33-0a4cf587ffb8
                © 2016 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 28 July 2015
                : 17 September 2015
                : 22 September 2015
                Page count
                Pages: 9
                Funding
                Funded by: National Health and Medical Research Council
                Award ID: 1049085
                Funded by: National Health and Medical Research Council, and he is a National Health and Medical Research Council Senior Research Fellow
                Award ID: 1020925
                Categories
                Osteoarthritis
                Osteoarthritis
                Custom metadata
                2.0
                acr22750
                May 2016
                Converter:WILEY_ML3GV2_TO_NLMPMC version:4.9.5 mode:remove_FC converted:21.10.2016

                Rheumatology
                Rheumatology

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