Rheumatoid Foot Insole

March 8, 2012 updated by: Emilia Moreira, PT, Federal University of São Paulo

Effect of Rheumatoid Foot Insole

The present study aims to evaluate the effect of insoles for foot arthritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A randomized, controlled, double-blind, prospective trial being conducted involving 80 patients with rheumatoid arthritis, according to American College of Rheumatology (ACR) criteria, and foot pain, selected from outpatient clinics - Federal University of Sao Paulo (UNIFESP).

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).

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Locations

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with established diagnosis RA according to criteria of the American College of Rheumatology (ACR) functional classes I, II and III
  • 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:

  • Other musculoskeletal disorders in symptomatic lower limbs
  • 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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention foot orthoses
Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital
Other: insoles intervention
EVA insole with arch support and bar retrocapital
Other Names:
  • Interventional group
Placebo Comparator: placebo insole
Foot orthose with support retrocapital and support of medial arch insole intervention
Other: placebo insole
EVA insole flat
Other Names:
  • control 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: 12 months
Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Function Index (FFI)
Time Frame: 12 months
Function of the foot
12 months
Foot Health Status Questionnaire (FHSQ-Br)
Time Frame: 12 months
Foot Health Status
12 months
Health Assessmente Questionnaire (HAQ)
Time Frame: 12 months
Functional capacity assessed by HAQ in rheumatoid arthritis
12 months
Visual analog scale of pain in feet at rest (VAS)
Time Frame: 12 months
Assessing pain in the feet at rest through a visual analog scale from 0 to 10
12 months
6-MINUTE WALK TEST
Time Frame: 12 months
Assess functional capacity
12 months
Shorth Form-36 (SF-36)
Time Frame: 12 months
Quality of life by SF-36
12 months
LIKERT SCALE
Time Frame: 12 months
Likert scale by patients
12 months
TESTS BAROPODOMETRIC
Time Frame: 12 months
Evaluates charge distribution in the feet and gait variables
12 months
TIME USE OF INSOLE
Time Frame: 12 months
Control the use of time insole
12 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: EMILIA MOREIRA, PT, Federal University of São Paulo
  • Study Chair: JAMIL NATOUR, PHD, Division of Rheumatology, Federal University of Sao Paulo

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

November 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1348/09

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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