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Journal Article•DOI•

Effectiveness of Off-the-Shelf, Extra-Depth Footwear in Reducing Foot Pain in Older People: A Randomized Controlled Trial

Hylton B. Menz1, Maria Auhl1, Sonja Ristevski1, Nicoletta Frescos1, Shannon E. Munteanu1 •
La Trobe University1
01 Apr 2015-Journals of Gerontology Series A-biological Sciences and Medical Sciences (Oxford University Press)-Vol. 70, Iss: 4, pp 511-517
TL;DR: Off-the-shelf, extra-depth footwear significantly reduces foot pain, improves foot function and is associated with the development of fewer keratotic lesions in older people.
Abstract: BACKGROUND Foot pain is highly prevalent in older people and in many cases is associated with inappropriate footwear. This study evaluated the effectiveness of off-the-shelf, extra-depth footwear in reducing foot pain. METHODS Community-dwelling older people with disabling foot pain (72 men and 48 women aged 65 to 96 years; mean age 82 [SD 8]) were randomly allocated to an intervention group (n = 59) or control group (n = 61). The intervention group was provided with off-the-shelf, extra-depth footwear. Participants in the control group received their footwear at the completion of the study. Both groups continued to receive usual podiatry care for the study period. The primary outcome measure was the Foot Health Status Questionnaire (FHSQ), measured at baseline and 16 weeks. RESULTS There was a significant improvement in the FHSQ pain domain (ANCOVA-adjusted mean difference 11.5 points, 95% confidence interval 4.2 to 18.8, p = .002) and FHSQ function domain (10.0 points, 0.9 to 19.1, p = .032) in the intervention group compared to the control group. The intervention group also developed fewer keratotic lesions (mean difference -1.4, -2.5 to -0.2, p = .021), were less likely to report the use of co-interventions (relative risk [RR] 0.74, 0.56 to 0.98, p = .026) and were more likely to report that their foot pain had moderately or markedly improved during the study (RR = 7.93, 2.51 to 25.00, p < .001; number needed to treat = 3, 2 to 5). CONCLUSIONS Off-the-shelf, extra-depth footwear significantly reduces foot pain, improves foot function and is associated with the development of fewer keratotic lesions in older people.

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Citations
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Journal Article•DOI•
Chronic foot pain in older people

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Hylton B. Menz1•
La Trobe University1
01 Sep 2016-Maturitas
TL;DR: The available evidence indicates that although foot pain is common and disabling in older people, conservative interventions such as routine foot care, footwear advice and foot orthoses are effective at reducing foot pain and may also assist in maintaining mobility and independence in this age group.

46 citations

Cites background from "Effectiveness of Off-the-Shelf, Ext..."

  • ...Indeed, a recent randomised trial has shown that the use of appropriate footwear is effective at reducing foot pain in older people [75]....

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Journal Article•DOI•
The relationship between foot and ankle symptoms and risk of developing knee osteoarthritis: data from the osteoarthritis initiative

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Kade L. Paterson1, Jessica Kasza2, David J. Hunter3, David J. Hunter4, Rana S Hinman1, Hylton B. Menz5, George Peat6, Kim L Bennell1 •
University of Melbourne1, Monash University2, Royal North Shore Hospital3, University of Sydney4, La Trobe University5, Arthritis Research UK6
01 May 2017-Osteoarthritis and Cartilage
TL;DR: In individuals at-risk of knee OA, the presence of contralateral foot/ankle symptoms in particular increases risk of developing both knee symptoms and symptomatic radiographic knee Oa.

30 citations

Journal Article•DOI•
Medical-grade footwear: the impact of fit and comfort

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Bessie Hurst1, Helen Branthwaite1, Andrew Greenhalgh1, Nachiappan Chockalingam1•
Staffordshire University1
05 Jan 2017-Journal of Foot and Ankle Research
TL;DR: The test shoe provided greater comfort and reduced the amount of pressure on the forefoot and the medical-grade footwear is a viable alternative to custom made prescription footwear and is more suitable than a regular everyday shoe when treating digital lesions associated with pressure.
Abstract: Pressure-related skin lesions on the digits are a significant cause of discomfort. Most foot pain related to ill-fitting shoes occurs in the forefoot and digital areas. Pain has been associated with poor shoe fit, reduced toe box volume, as well as contour and shape of the shoe Off-the-shelf medical-grade footwear is designed as an intervention for chronic lesions on the digits. These shoes are designed with a flexible neoprene fabric upper that is thought to reduce pressure on the forefoot and reduce discomfort associated with ill-fitting shoes. The aim of this study was to investigate the effect of an off-the-shelf, medical-grade shoe on dorsal digital pressure and perceived comfort when compared to participant’s own preferred shoe. Thirty participants (18 females, 12 males) scored their perceived comfort whilst wearing each footwear style using a visual analog comfort scale. Dorsal digital and interdigital pressures were measured in using the WalkinSense® in-shoe pressure system. Sensors were placed on predetermined anatomical landmarks on the digits. Participants were randomly assigned the test shoe and their own shoe. Once wearing the shoe, the participants walked across a 6 m walkway and pressure data from each sensor was collected and processed to obtain peak pressure, time to peak pressure and contact time. Participants scored the test shoe with higher comfort points than their own footwear. Overall peak pressure, pressure time integral and contact time decreased, whilst the time taken to reach peak pressure increased across all anatomical landmarks whilst wearing the test shoe. Statistically significant changes were observed for all of the measured variables relating to pressure on the medial border of the first metatarsophalangeal joint. The test shoe provided greater comfort and reduced the amount of pressure on the forefoot. The medical-grade footwear therefore, is a viable alternative to custom made prescription footwear and is more suitable than a regular everyday shoe when treating digital lesions associated with pressure.

27 citations

Cites background from "Effectiveness of Off-the-Shelf, Ext..."

  • ...Although improved styling and newer materials used within the off-the-shelf medical-grade footwear (M-GF) has helped to increase compliance in wearing the shoe [21], there is still a lack of empirical data to support the use of these shoes for pressure reduction on the dorsum of the foot....

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Journal Article•DOI•
Comparison of the responsiveness of the foot health status questionnaire and the Manchester foot pain and disability index in older people.

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Hylton B. Menz1, Maria Auhl1, Sonja Ristevski1, Nicoletta Frescos1, Shannon E. Munteanu1 •
La Trobe University1
25 Oct 2014-Health and Quality of Life Outcomes
TL;DR: The FHSQ pain and function subscales were most responsive to change in older people with foot pain receiving a footwear intervention, and provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials of foot disorders.
Abstract: In recent years, several questionnaires have been developed for the assessment of foot health and its impact on quality of life. In order for these tools to be useful outcome measures in clinical trials, their ability to detect change over time (responsiveness) needs to be determined. Therefore, the aim of this study was to assess the responsiveness of two commonly-used questionnaires in older people with foot pain. Participants (n = 59; 24 women and 35 men, mean age [SD] 82.3 [7.8] years) allocated to the intervention arm of a randomised controlled trial assessing the effectiveness of extra-depth footwear compared to usual care completed the Foot Health Status Questionnaire (FHSQ) and Manchester Foot Pain and Disability Index (MFPDI) at baseline and 16 weeks. Responsiveness of the FHSQ subscales (pain, function, footwear and general foot health) and MFPDI subscales (pain, functional limitation and concern about appearance) was determined using (i) paired t-tests, (ii) Cohen's d, (iii) the standardised response mean (SRM), and (iv) the Guyatt index. Overall, the FHSQ pain subscale exhibited the highest responsiveness, as evidenced by a highly significant paired t-test (p <0.001), Cohen's d = 0.63 (medium effect size), SRM = 0.50 (medium effect size) and Guyatt index = 1.70 (huge effect size). The next most responsive measure was the FHSQ function subscale, as evidenced by a borderline paired t-test (p = 0.050), Cohen's d = 0.37 (small effect size), SRM = 0.26 (small effect size) and GI = 1.22 (very large effect size). The FHSQ footwear, FHSQ general foot health and MFPDI pain, functional limitation and concern about appearance subscales demonstrated lower responsiveness, with negligible to medium effect sizes. The FHSQ pain and function subscales were most responsive to change in older people with foot pain receiving a footwear intervention. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials of foot disorders.

24 citations

Journal Article•DOI•
Podiatry interventions to prevent falls in older people: a systematic review and meta-analysis

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Gavin Wylie1, Claire Torrens2, Pauline Campbell3, Helen Frost4, Adam L. Gordon5, Hylton B. Menz6, Dawn A. Skelton3, Francis Sullivan7, Miles D. Witham1, Jacqui Morris1 •
University of Dundee1, University of Stirling2, Glasgow Caledonian University3, Edinburgh Napier University4, University of Nottingham5, La Trobe University6, University of St Andrews7
01 May 2019-Age and Ageing
TL;DR: In this article, a systematic review examined podiatry interventions for falls prevention delivered in the community and in care homes in older adults (aged 60+) and found that the effectiveness of these interventions to prevent falls in older people is unknown.
Abstract: Background foot problems are independent risk factors for falls in older people. Podiatrists diagnose and treat a wide range of problems affecting the feet, ankles and lower limbs. However, the effectiveness of podiatry interventions to prevent falls in older people is unknown. This systematic review examined podiatry interventions for falls prevention delivered in the community and in care homes. Methods systematic review and meta-analysis. We searched multiple electronic databases with no language restrictions. Randomised or quasi-randomised-controlled trials documenting podiatry interventions in older people (aged 60+) were included. Two reviewers independently applied selection criteria and assessed methodological quality using the Cochrane Risk of Bias tool. TiDieR guidelines guided data extraction and where suitable statistical summary data were available, we combined the selected outcome data in pooled meta-analyses. Results from 35,857 titles and 5,201 screened abstracts, nine studies involving 6,502 participants (range 40-3,727) met the inclusion criteria. Interventions were single component podiatry (two studies), multifaceted podiatry (three studies), or multifactorial involving other components and referral to podiatry component (four studies). Seven studies were conducted in the community and two in care homes. Quality assessment showed overall low risk for selection bias, but unclear or high risk of detection bias in 4/9 studies. Combining falls rate data showed significant effects for multifaceted podiatry interventions compared to usual care (falls rate ratio 0.77 [95% CI 0.61, 0.99]); and multifactorial interventions including podiatry (falls rate ratio: 0.73 [95% CI 0.54, 0.98]). Single component podiatry interventions demonstrated no significant effects on falls rate. Conclusions multifaceted podiatry interventions and multifactorial interventions involving referral to podiatry produce significant reductions in falls rate. The effect of multi-component podiatry interventions and of podiatry within multifactorial interventions in care homes is unknown and requires further trial data. Prospero registration number CRD42017068300.

17 citations

References
More filters
Journal Article•DOI•
A 12-Item Short-Form Health Survey: Construction of Scales and Preliminary Tests of Reliability and Validity

[...]

John E. Ware1, Mark Kosinski, Susan D. Keller•
Tufts Medical Center1
28 Feb 1996-Medical Care
TL;DR: Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions.
Abstract: Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.

14,793 citations

"Effectiveness of Off-the-Shelf, Ext..." refers methods in this paper

  • ...0 (29), the number of falls experienced during the follow-up period, the Timed Up and Go Test (30), presence of keratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain (documented with a diary that was returned at 4, 8, 12, and 16 weeks), and participants’ perception of overall treatment effect at week 16, assessed with the question “Overall, how has your foot pain changed since the start of the study?” with a 5-point Likert scale response (“marked worsening,” “moderate worsening,” “same,” “moderate improvement,” or “marked improvement”)....

    [...]

Journal Article•DOI•
The Timed “Up & Go”: A Test of Basic Functional Mobility for Frail Elderly Persons

[...]

Diane Podsiadlo1, Sandra Richardson•
McGill University1
01 Feb 1991-Journal of the American Geriatrics Society
TL;DR: This study evaluated a modified, timed version of the “Get‐Up and Go” Test (Mathias et al, 1986) in 60 patients referred to a Geriatric Day Hospital and suggested that the timed “Up & Go’ test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change over time.
Abstract: This study evaluated a modified, timed version of the "Get-Up and Go" Test (Mathias et al, 1986) in 60 patients referred to a Geriatric Day Hospital (mean age 79.5 years). The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. The results indicate that the time score is (1) reliable (inter-rater and intra-rater); (2) correlates well with log-transformed scores on the Berg Balance Scale (r = -0.81), gait speed (r = -0.61) and Barthel Index of ADL (r = -0.78); and (3) appears to predict the patient's ability to go outside alone safely. These data suggest that the timed "Up & Go" test is a reliable and valid test for quantifying functional mobility that may also be useful in following clinical change over time. The test is quick, requires no special equipment or training, and is easily included as part of the routine medical examination.

12,004 citations

"Effectiveness of Off-the-Shelf, Ext..." refers methods in this paper

  • ...0 (29), the number of falls experienced during the follow-up period, the Timed Up and Go Test (30), presence of keratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain (documented with a diary that was returned at 4, 8, 12, and 16 weeks), and participants’ perception of overall treatment effect at week 16, assessed with the question “Overall, how has your foot pain changed since the start of the study?” with a 5-point Likert scale response (“marked worsening,” “moderate worsening,” “same,” “moderate improvement,” or “marked improvement”)....

    [...]

  • ...Secondary outcome measures were documented at baseline and 16 weeks and included the function domain of the FHSQ, the functional limitation, pain intensity and concern about appearance subscales of the MFPDI (21), the number of DVA-funded podiatry consultations documented during the study period, general health status, assessed with the Short Form 12 Version 2.0 (29), the number of falls experienced during the follow-up period, the Timed Up and Go Test (30), presence of keratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain (documented with a diary that was returned at 4, 8, 12, and 16 weeks), and participants’ perception of overall treatment effect at week 16, assessed with the question “Overall, how has your foot pain changed since the start of the study?” with a 5-point Likert scale response (“marked worsening,” “moderate worsening,” “same,” “moderate improvement,” or “marked improvement”)....

    [...]

Journal Article•DOI•
Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls.

[...]

Jonathan A C Sterne, Ian R. White1, John B. Carlin2, Michael Spratt1, Patrick Royston, Michael G. Kenward3, Angela M. Wood4, James R. Carpenter3 •
University of Bristol1, University of Melbourne2, University of London3, University of Cambridge4
29 Jun 2009-BMJ
TL;DR: The appropriate use and reporting of the multiple imputation approach to dealing with missing data is described by Jonathan Sterne and colleagues.
Abstract: Most studies have some missing data. Jonathan Sterne and colleagues describe the appropriate use and reporting of the multiple imputation approach to dealing with them

5,293 citations

"Effectiveness of Off-the-Shelf, Ext..." refers methods in this paper

  • ...We used multiple imputation to replace any missing data using five iterations, with age, baseline scores, and group allocation as predictors (31)....

    [...]

Journal Article•DOI•
A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients

[...]

Eric Pfeiffer1•
Duke University1
01 Oct 1975-Journal of the American Geriatrics Society
TL;DR: A 10‐item Short Portable Mental Status Questionnaire (SPMSQ), easily administered by any clinician in the office or in a hospital, has been designed, tested, standardized and validated.
Abstract: Clinicians whose practice includes elderly patients need a short, reliable instrument to detect the presence of intellectual impairment and to determine the degree. A 10-item Short Portable Mental Status Questionnaire (SPMSQ), easily administered by any clinician in the office or in a hospital, has been designed, tested, standardized and validated. The standardization and validation procedure included administering the test to 997 elderly persons residing in the community, to 141 elderly persons referred for psychiatric and other health and social problems to a multipurpose clinic, and to 102 elderly persons living in institutions such as nursing homes, homes for the aged, or state mental hospitals. It was found that educational level and race had to be taken into account in scoring individual performance. On the basis of the large community population, standards of performance were established for: 1) intact mental functioning, 2) borderline or mild organic impairment, 3) definite but moderate organic impairment, and 4) severe organic impairment. In the 141 clinic patients, the SPMSQ scores were correlated with the clinical diagnoses. There was a high level of agreement between the clinical diagnosis of organic brain syndrome and the SPMSQ scores that indicated moderate or severe organic impairment.

4,897 citations

"Effectiveness of Off-the-Shelf, Ext..." refers background in this paper

  • ...Exclusion criteria included residing in a residential aged care facility, diabetes and current or previous foot ulceration, diabetic peripheral neuropathy, neurodegenerative disorders, lower limb or partial foot amputation, having been prescribed contoured foot orthoses within the past 3 months, currently wearing the intervention footwear, or cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire) (22)....

    [...]

  • ...Exclusion criteria included residing in a residential aged care facility, diabetes and current or previous foot ulceration, diabetic peripheral neuropathy, neurodegenerative disorders, lower limb or partial foot amputation, having been prescribed contoured foot orthoses within the past 3 months, currently wearing the intervention footwear, or cognitive impairment (defined as a score of 7 on the Short Portable Mental Status Questionnaire) (22)....

    [...]

Journal Article•DOI•
Adjusting for multiple testing--when and how?

[...]

Ralf Bender, Stefan Lange1•
Ruhr University Bochum1
01 Apr 2001-Journal of Clinical Epidemiology
TL;DR: The existing multiple test procedures are summarized for the most important multiplicity situations and it is emphasized that adjustments for multiple testing are required in confirmatory studies whenever results from multiple tests have to be combined in one final conclusion and decision.

2,222 citations

"Effectiveness of Off-the-Shelf, Ext..." refers background in this paper

  • ...However, to address the issue of multiple testing of serial measurements (28) we pre-specified 16 weeks as the single primary end-point and no statistical comparisons of the 4, 8, and 12 week scores were undertaken....

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