Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
312 participants
INTERVENTIONAL
2009-09-30
2013-02-28
Brief Summary
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SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. To analyze the state of general health and of quality of the patients' life in all the treatment groups. To analyze the study cost-effectiveness of each one of the experimental interventions. DESIGN: randomized controled trial, prospective.
SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U. Sciences of the Health with footpain like consultation reason.
INTERVENTION: Establishment of four experimental groups with intervention varied podológica. He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24 months, by means of pain scales and function of the foot (FHSQ), the index postural of the foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health (SF-12) and quality of life (Euroqol).
VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry, of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of general health (SF12) and quality of life (Euroqol). Variables of characterization of the sample.
ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the study variables. They will be carried out statistical inferenciales between the main variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon, according to types and normality of variables). Likewise, measures of the size of the effect will settle down in the main variables of result, by means of the relative reduction of the risk, absolute risk and odds ratio, with their respective intervals of trust.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
chiropody
basic procedure of chiropody in podiatry
2
basic orthesis
individual basic orthesis of foot
3
advantage orthesis
advantage orthesis of foot with special material and design
4
chiropody and advantage orthesis
chiropody and advantage orthesis of foot
Interventions
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chiropody
basic procedure of chiropody in podiatry
basic orthesis
individual basic orthesis of foot
advantage orthesis
advantage orthesis of foot with special material and design
chiropody and advantage orthesis
chiropody and advantage orthesis of foot
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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University of Malaga
OTHER
Responsible Party
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Dr. Antonio I Cuesta-Vargas
PhD
Locations
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Clinica Podologia de la Universidad de malaga
Málaga, Malaga, Spain
Health Science School , University of Malaga
Málaga, Malaga, Spain
Countries
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Related Links
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University of Malaga
Health Science School
Ethics Comite Andalucia
Other Identifiers
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173908909-8909-4-9
Identifier Type: -
Identifier Source: org_study_id
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