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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2011-11-30
2012-11-30
Brief Summary
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Detailed Description
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Patients will be randomized in to two groups: experimental (40) and control (40).
The experimental group will use ethyl-vinyl acetate (EVA) foot orthoses, with support retrocapital and support of medial arch (insole intervention). The control group will use the same material flat insole (insole placebo).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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intervention foot orthoses
Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital
insoles intervention
EVA insole with arch support and bar retrocapital
placebo insole
Foot orthose with support retrocapital and support of medial arch insole intervention
placebo insole
EVA insole flat
Interventions
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insoles intervention
EVA insole with arch support and bar retrocapital
placebo insole
EVA insole flat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Foot pain with VAS between 3 - 8 cm for walking
* Age 18-65 years
* Basic medication stable for at least three months
* Not made infiltrations in feet and ankles in the last three months and not during the study
* Agreed to participate and signed term of informed consent
Exclusion Criteria
* Diseases of the central and peripheral nervous system
* Decompensated diabetes mellitus
* No walking
* Rigid deformities in the feet
* Use of insoles in the last three months
* Surgery scheduled in the next 12 months
* Allergy to the material
* Mental deficiency
18 Years
65 Years
FEMALE
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Federal University of São Paulo
OTHER
Responsible Party
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Emilia Moreira, PT
Effect of rheumatoid foot insole
Principal Investigators
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EMILIA MOREIRA, PT
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
ANAMARIA PT JONES, PHD
Role: STUDY_DIRECTOR
Federal University of São Paulo
JAMIL NATOUR, PHD
Role: STUDY_CHAIR
Division of Rheumatology, Federal University of Sao Paulo
Locations
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Emilia Moreira
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1348/09
Identifier Type: -
Identifier Source: org_study_id
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