Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice
<p>Abstract</p> <p>Background</p> <p>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...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2011-03-01
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| Series: | Journal of Foot and Ankle Research |
| Online Access: | http://www.jfootankleres.com/content/4/1/11 |
| _version_ | 1797331281694949376 |
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| author | Peeraer Louis Gorter Kees J Knol Dirk L Elders Petra JM van der Zwaard Babette C van der Windt Daniëlle AWM van der Horst Henriëtte E |
| author_facet | Peeraer Louis Gorter Kees J Knol Dirk L Elders Petra JM van der Zwaard Babette C van der Windt Daniëlle AWM van der Horst Henriëtte E |
| author_sort | Peeraer Louis |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2212">NTR2212</a></p> |
| first_indexed | 2024-03-08T07:32:11Z |
| format | Article |
| id | doaj.art-897fbde877c64c7fa8dea3b82188c0c4 |
| institution | Directory Open Access Journal |
| issn | 1757-1146 |
| language | English |
| last_indexed | 2024-03-08T07:32:11Z |
| publishDate | 2011-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Foot and Ankle Research |
| spelling | doaj.art-897fbde877c64c7fa8dea3b82188c0c42024-02-02T20:12:45ZengBMCJournal of Foot and Ankle Research1757-11462011-03-01411110.1186/1757-1146-4-11Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advicePeeraer LouisGorter Kees JKnol Dirk LElders Petra JMvan der Zwaard Babette Cvan der Windt Daniëlle AWMvan der Horst Henriëtte E<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2212">NTR2212</a></p>http://www.jfootankleres.com/content/4/1/11 |
| spellingShingle | Peeraer Louis Gorter Kees J Knol Dirk L Elders Petra JM van der Zwaard Babette C van der Windt Daniëlle AWM van der Horst Henriëtte E Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice Journal of Foot and Ankle Research |
| title | Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
| title_full | Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
| title_fullStr | Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
| title_full_unstemmed | Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
| title_short | Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
| title_sort | treatment of forefoot problems in older people study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice |
| url | http://www.jfootankleres.com/content/4/1/11 |
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