Rheumatoid Foot Insole

Federal University of São Paulo80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

insoles interventionOTHER

EVA insole with arch support and bar retrocapital

placebo insoleOTHER

EVA insole flat

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Emilia Moreira

São Paulo, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Visual analog scale of pain in feet during walking (VAS)

Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)

Time frame: 12 months

Secondary Outcomes

Foot Function Index (FFI)

Function of the foot

Time frame: 12 months

Foot Health Status Questionnaire (FHSQ-Br)

Foot Health Status

Time frame: 12 months

Health Assessmente Questionnaire (HAQ)

Functional capacity assessed by HAQ in rheumatoid arthritis

Time frame: 12 months

Visual analog scale of pain in feet at rest (VAS)

Assessing pain in the feet at rest through a visual analog scale from 0 to 10

Time frame: 12 months

6-MINUTE WALK TEST

Assess functional capacity

Time frame: 12 months

Shorth Form-36 (SF-36)

Quality of life by SF-36

Time frame: 12 months

LIKERT SCALE

Likert scale by patients

Time frame: 12 months

TESTS BAROPODOMETRIC

Evaluates charge distribution in the feet and gait variables

Time frame: 12 months

Central Contacts

Emilia Moreira

CONTACT

551125942014 emilia.moreira@hotmail.com

Jamil MD Natour, PHD

CONTACT

551155764239 jnatour@unifesp.br

Data from ClinicalTrials.gov

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