Rheumatoid Foot Insole

Study Overview
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Brief Summary
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The present study aims to evaluate the effect of insoles for foot arthritis.

Detailed Description
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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).

Official Title
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Effect of Rheumatoid Foot Insole

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: insoles intervention
* Other: placebo insole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention foot orthoses<br>Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital | Other: insoles intervention<br>* EVA insole with arch support and bar retrocapital<br>* Other names: Interventional group;|
| Placebo Comparator: placebo insole<br>Foot orthose with support retrocapital and support of medial arch insole intervention | Other: placebo insole<br>* EVA insole flat<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Function Index (FFI) | Function of the foot | 12 months | 
| Foot Health Status Questionnaire (FHSQ-Br) | Foot Health Status | 12 months | 
| Health Assessmente Questionnaire (HAQ) | Functional capacity assessed by HAQ in rheumatoid arthritis | 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 | 12 months | 
| 6-MINUTE WALK TEST | Assess functional capacity | 12 months | 
| Shorth Form-36 (SF-36) | Quality of life by SF-36 | 12 months | 
| LIKERT SCALE | Likert scale by patients | 12 months | 
| TESTS BAROPODOMETRIC | Evaluates charge distribution in the feet and gait variables | 12 months | 
| TIME USE OF INSOLE | Control the use of time insole | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid foot, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis