Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice
Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these...
Ausführliche Beschreibung
Autor*in: |
van der Zwaard, Babette C [verfasserIn] |
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E-Artikel |
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Englisch |
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2011 |
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Anmerkung: |
© van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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Übergeordnetes Werk: |
Enthalten in: Journal of foot and ankle research - London : BioMed Central, 2008, 4(2011), 1 vom: 31. März |
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Übergeordnetes Werk: |
volume:4 ; year:2011 ; number:1 ; day:31 ; month:03 |
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DOI / URN: |
10.1186/1757-1146-4-11 |
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Katalog-ID: |
SPR029653061 |
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520 | |a Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 | ||
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10.1186/1757-1146-4-11 doi (DE-627)SPR029653061 (SPR)1757-1146-4-11-e DE-627 ger DE-627 rakwb eng van der Zwaard, Babette C verfasserin aut Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 General Practitioner (dpeaa)DE-He213 Diabetic Neuropathy (dpeaa)DE-He213 Numerical Rating Scale (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Forefoot Pain (dpeaa)DE-He213 Elders, Petra JM aut Knol, Dirk L aut Gorter, Kees J aut Peeraer, Louis aut van der Windt, Daniëlle AWM aut van der Horst, Henriëtte E aut Enthalten in Journal of foot and ankle research London : BioMed Central, 2008 4(2011), 1 vom: 31. März (DE-627)573742634 (DE-600)2440706-9 1757-1146 nnns volume:4 year:2011 number:1 day:31 month:03 https://dx.doi.org/10.1186/1757-1146-4-11 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 4 2011 1 31 03 |
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10.1186/1757-1146-4-11 doi (DE-627)SPR029653061 (SPR)1757-1146-4-11-e DE-627 ger DE-627 rakwb eng van der Zwaard, Babette C verfasserin aut Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 General Practitioner (dpeaa)DE-He213 Diabetic Neuropathy (dpeaa)DE-He213 Numerical Rating Scale (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Forefoot Pain (dpeaa)DE-He213 Elders, Petra JM aut Knol, Dirk L aut Gorter, Kees J aut Peeraer, Louis aut van der Windt, Daniëlle AWM aut van der Horst, Henriëtte E aut Enthalten in Journal of foot and ankle research London : BioMed Central, 2008 4(2011), 1 vom: 31. März (DE-627)573742634 (DE-600)2440706-9 1757-1146 nnns volume:4 year:2011 number:1 day:31 month:03 https://dx.doi.org/10.1186/1757-1146-4-11 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 4 2011 1 31 03 |
allfields_unstemmed |
10.1186/1757-1146-4-11 doi (DE-627)SPR029653061 (SPR)1757-1146-4-11-e DE-627 ger DE-627 rakwb eng van der Zwaard, Babette C verfasserin aut Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 General Practitioner (dpeaa)DE-He213 Diabetic Neuropathy (dpeaa)DE-He213 Numerical Rating Scale (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Forefoot Pain (dpeaa)DE-He213 Elders, Petra JM aut Knol, Dirk L aut Gorter, Kees J aut Peeraer, Louis aut van der Windt, Daniëlle AWM aut van der Horst, Henriëtte E aut Enthalten in Journal of foot and ankle research London : BioMed Central, 2008 4(2011), 1 vom: 31. März (DE-627)573742634 (DE-600)2440706-9 1757-1146 nnns volume:4 year:2011 number:1 day:31 month:03 https://dx.doi.org/10.1186/1757-1146-4-11 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 4 2011 1 31 03 |
allfieldsGer |
10.1186/1757-1146-4-11 doi (DE-627)SPR029653061 (SPR)1757-1146-4-11-e DE-627 ger DE-627 rakwb eng van der Zwaard, Babette C verfasserin aut Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 General Practitioner (dpeaa)DE-He213 Diabetic Neuropathy (dpeaa)DE-He213 Numerical Rating Scale (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Forefoot Pain (dpeaa)DE-He213 Elders, Petra JM aut Knol, Dirk L aut Gorter, Kees J aut Peeraer, Louis aut van der Windt, Daniëlle AWM aut van der Horst, Henriëtte E aut Enthalten in Journal of foot and ankle research London : BioMed Central, 2008 4(2011), 1 vom: 31. März (DE-627)573742634 (DE-600)2440706-9 1757-1146 nnns volume:4 year:2011 number:1 day:31 month:03 https://dx.doi.org/10.1186/1757-1146-4-11 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 4 2011 1 31 03 |
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10.1186/1757-1146-4-11 doi (DE-627)SPR029653061 (SPR)1757-1146-4-11-e DE-627 ger DE-627 rakwb eng van der Zwaard, Babette C verfasserin aut Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 General Practitioner (dpeaa)DE-He213 Diabetic Neuropathy (dpeaa)DE-He213 Numerical Rating Scale (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Forefoot Pain (dpeaa)DE-He213 Elders, Petra JM aut Knol, Dirk L aut Gorter, Kees J aut Peeraer, Louis aut van der Windt, Daniëlle AWM aut van der Horst, Henriëtte E aut Enthalten in Journal of foot and ankle research London : BioMed Central, 2008 4(2011), 1 vom: 31. März (DE-627)573742634 (DE-600)2440706-9 1757-1146 nnns volume:4 year:2011 number:1 day:31 month:03 https://dx.doi.org/10.1186/1757-1146-4-11 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 4 2011 1 31 03 |
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Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
abstract |
Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
abstractGer |
Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
abstract_unstemmed |
Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. Discussion Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. Trial registration Netherlands Trial Register (NTR): NTR2212 © van der Zwaard et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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title_short |
Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
url |
https://dx.doi.org/10.1186/1757-1146-4-11 |
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author2 |
Elders, Petra JM Knol, Dirk L Gorter, Kees J Peeraer, Louis van der Windt, Daniëlle AWM van der Horst, Henriëtte E |
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Elders, Petra JM Knol, Dirk L Gorter, Kees J Peeraer, Louis van der Windt, Daniëlle AWM van der Horst, Henriëtte E |
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