|- candidate number||7757|
|- NTR Number||NTR2212|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-feb-2010|
|- Secondary IDs||OZ 06072040 / WC 2008-091 ; Projectnr Vumc / Wetenschapscommissie Vumc|
|- Public Title||Treatment of forefoot problems: shoe advice versus podiatric treatment.|
|- Scientific Title||Treatment of forefoot problems in the elderly: a randomised controlled trial of standardised shoe advice versus podiactric treatment.|
|- ACRONYM||Het voetenproject|
|- hypothesis||Podiatric treatment has a bigger effect on the primary and secondary outcomes then a standardised shoe advice.|
|- Healt Condition(s) or Problem(s) studied||Musculoskeletal forefootproblems|
|- Inclusion criteria||1. 50 years of age or older; |
2. Non traumatic forefoot problem (= MTP joint or more distal);
3. Pain > 1 month.
|- Exclusion criteria||1. Problem caused by other then musculoskeletal (e.g. wart, fungal infection);|
2. Problem treated in previous year;
3. Neuropathy of the foot;
4. Rheumatic arthritis;
5. Unable to walk 7 mtrs without walking aid;
6. Unable to fill in questionnaire.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||200|
|- Interventions||1. Group 1: standardised shoe advice by means of leaflet;|
2. Group 2: podiatric treatment by registered podiatrists.
|- Primary outcome||1. Foot Disability Index (FDI);|
2. Foot function index (FFI);
3. Pain grade (VAS).
|- Secondary outcome||1. Keele assessment of participation (KAP);|
2. General health and wellbeing (SF12);
3. Treatment adherence.
|- Timepoints||At the start of the study and at 3, 6, 9,12 and 18 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| B. Zwaard, van de|
|- CONTACT for SCIENTIFIC QUERIES|| P.J.M. Elders|
|- Sponsor/Initiator ||EMGO Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, EMGO+ Institute, Fontys University of applied sciences, Eindhoven|
|- Brief summary||Background:|
Foot pain can lead to a decrease in mobility and a higher risk at falling. Foot problems and pain increase with age and are more common in women than man. Around 20% of people over 65 suffer from non traumatic foot complaints and 60 % of these problems occur in the forefoot. Little is know of the best way to treat forefoot problems with the elderly. The aim of this study is to compare the effect of the two main treatments in the Netherlands: shoe advice and podiatric treatment.
The study is designed as a randomised controlled trial (RCT). People 55 years or older who have visited their General Practitioner (GP) last year and who will visit their GP during the inclusion period with non traumatic pain in the forefoot will be recruited for this study. Others will be notified by means of posters in the waiting area of the GP office. Exclusion criteria are having Rheumatoid Arthritis, a Neuropathy of the foot or pain caused by spin problems (e.g. warts, eczema). Subjects will have to be able to walk 7 metres unaided and fill in questionnaires. Inclusion and exclusion criteria are evaluated by a screenings questionnaire and an entrance examination. Subjects are randomly assigned to either receive a standardised shoe advice leaflet (n=100) or podiatric treatment (n=100). Primary outcomes will be pain VAS score and foot function (Foot Function 5-pts index). Treatment compliance and adherence, foot disability, social participation and quality of life will be the secondary outcomes. Both will be obtained by self administered questionnaires at the start of the study and at 3, 6, 9, 12 and 18 months. Data will be analysed according to the intention-to-treat principle.
Strengths of this study are the comparison of two practical treatments which are mainly used by Dutch GP’s and the lack of evidence which currently exist for elderly with forefoot pain. The results of this study can be translated to a practical treatment protocol for GP’s.
|- Main changes (audit trail)|
|- RECORD||12-feb-2010 - 5-mrt-2010|