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
NA
72 participants
INTERVENTIONAL
2015-06-01
2018-03-31
Brief Summary
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Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention Group
Customized insole with metatarsal support
Insole
Customized insole
Control Group
Placebo flat insole
Placebo Insole
Placebo flat insole
Interventions
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Insole
Customized insole
Placebo Insole
Placebo flat insole
Eligibility Criteria
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Inclusion Criteria
* Pain in the foot with VAS between 3-8 cm to walk.
* Over 18 years.
* No distinction of sex
* Agree to participate of the study and sign the informed consent form.
Exclusion Criteria
* Symptomatic diseases of the central and peripheral nervous system.
* Diabetes Mellitus.
* Rigid deformities on foot.
* Use of insoles in the last three months.
* Physiotherapy in the last three months.
* Infiltrations on foot and ankles in the last three months.
* Previous or expected surgery in the next twelve months.
* Allergy to the material of the insole.
* Mental deficiency.
* Geographic inaccessibility .- Use of corticosteroids or NSAIDs in the last month
18 Years
ALL
No
Sponsors
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Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Federal University of São Paulo
OTHER
Responsible Party
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Hilda Alcantara Veiga de Oliveira
PT, MsC
Other Identifiers
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20634013.9.0000.5505.
Identifier Type: -
Identifier Source: org_study_id