Plantar Fasciitis Foot Insole

NCT ID: NCT01549678

Last Updated: 2012-03-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-08-31

Brief Summary

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The hypothesis to be tested is that the use of total contact insoles for six months reduces foot pain, improves function and quality of life of patients diagnosed with plantar fasciitis.

Detailed Description

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Patients diagnosed with plantar fasciitis, foot pain with VAS between 3 - 8 for walk, over 18 years, regardless of gender who agreed to participate and signing the consent form. Pacietes We excluded patients with other symptomatic lower limb musculoskeletal diseases, diabetes mellitus, rigid deformities in the feet, which made use of insoles, physiotherapy or injections in feet and ankles in the last three months, and previous surgery or planned within the next twelve months.

Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention foot orthoses

Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.

Group Type EXPERIMENTAL

Total contact insole

Intervention Type OTHER

EVA insole shaped on patient´s foot.

Placebo insole

EVA flat insole.

Group Type PLACEBO_COMPARATOR

placebo insole

Intervention Type OTHER

EVA insole flat

Interventions

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Total contact insole

EVA insole shaped on patient´s foot.

Intervention Type OTHER

placebo insole

EVA insole flat

Intervention Type OTHER

Other Intervention Names

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Intervention group Placebo group

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age with a diagnosis of PF and foot pain while walking ranging from 3 to 8 points on a 10-point pain scale were analyzed

Exclusion Criteria

* Patients with other musculoskeletal conditions in symptomatic lower limbs, inflammatory conditions of the central or peripheral nervous systems, diabetes mellitus or an inability to walk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Hilda Alcantara Veiga de Oliveira

Effect of Fasciitis Plantar Foot Insoles

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilda PT Oliveira

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Anamaria PT Jones, PHD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Jamil MD Natour, PHD

Role: STUDY_CHAIR

Chief of Rheumatology, Federal

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Hilda Oliveira

Role: CONTACT

551126910469

Jamil MD Natour, PHD

Role: CONTACT

551155764239

Facility Contacts

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Hilda PT Oliveira

Role: primary

551126910469

Jamil MD Natour, PHD

Role: backup

551155764239

Other Identifiers

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1349/09

Identifier Type: -

Identifier Source: org_study_id

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