Plantar Fasciitis Foot Insole

March 7, 2012 updated by: Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo

Effect of Plantar Fasciitis Foot Insole

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Federal University of São Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention foot orthoses
Ethyl Vinil Acetate EVA insole shaped in the cast of the patient's foot.
Other: Total contact insole
EVA insole shaped on patient´s foot.
Other Names:
  • Intervention group
PLACEBO_COMPARATOR: Placebo insole
EVA flat insole.
Other: placebo insole
EVA insole flat
Other Names:
  • Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale of pain in feet during walking (VAS)
Time Frame: Six months
Assessing pain in the feet during walking through a visual analog scale from 0 to 10
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FFI
Time Frame: 6 months
Questionaire of function of the foot
6 months
FHSQ-Br
Time Frame: 6 months
Foot Health Status Questionaire
6 months
Visual analog scale of pain in feet at reset (VAS)
Time Frame: 6 months
Assessing pain in the feet at reset through a visual analog scale from 0 to 10
6 months
6-MINUTE WALK TEST
Time Frame: 6 months
Assess functional capacity
6 months
SF-36
Time Frame: 12 months
Assess functional capacity
12 months
Likert scale
Time Frame: 6 months
Likert scale by patients
6 months
Baropodometric tests
Time Frame: 6 months
Evaluates charge gistribution in the feet and gait variables
6 months
Time use of insole
Time Frame: 6 months
Control use of insole
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Hilda PT Oliveira, Federal University of São Paulo
  • Study Chair: Jamil MD Natour, PHD, Chief of Rheumatology, Federal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1349/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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