Rheumatoid Foot Insole

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Other: insoles intervention; Other: placebo insole

• Registration Number: NCT01546610
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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 Timeline

• Study Start: 2011-11
• Status Verified: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Last Update Submitted: 2012-03-08
• Last Update Posted: 2012-03-09
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention foot orthoses	insoles intervention	Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital
placebo insole	placebo insole	Foot orthose with support retrocapital and support of medial arch insole intervention

Primary Outcome Measures

Name	Time	Method
Visual analog scale of pain in feet during walking (VAS)	12 months	Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)

Secondary Outcome Measures

Name	Time	Method
Foot Function Index (FFI)	12 months	Function of the foot
Foot Health Status Questionnaire (FHSQ-Br)	12 months	Foot Health Status
Health Assessmente Questionnaire (HAQ)	12 months	Functional capacity assessed by HAQ in rheumatoid arthritis
Visual analog scale of pain in feet at rest (VAS)	12 months	Assessing pain in the feet at rest through a visual analog scale from 0 to 10
6-MINUTE WALK TEST	12 months	Assess functional capacity
Shorth Form-36 (SF-36)	12 months	Quality of life by SF-36
LIKERT SCALE	12 months	Likert scale by patients
TESTS BAROPODOMETRIC	12 months	Evaluates charge distribution in the feet and gait variables
TIME USE OF INSOLE	12 months	Control the use of time insole

Trial Locations

Locations (1)

Emilia Moreira; 🇧🇷 Sao Paulo, Brazil