Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid foot, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
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).
Interventions
OTHERinsoles intervention
EVA insole with arch support and bar retrocapital
OTHERplacebo insole
EVA insole flat
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Health Assessmente Questionnaire (HAQ) | 12 months | Functional capacity assessed by HAQ in rheumatoid arthritis |
| Foot Function Index (FFI) | 12 months | Function of the foot |
| 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 |
| Foot Health Status Questionnaire (FHSQ-Br) | 12 months | Foot Health Status |
| 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 |
| Shorth Form-36 (SF-36) | 12 months | Quality of life by SF-36 |
Countries
Brazil
Contacts
Primary ContactEmilia Moreira
Backup ContactJamil MD Natour, PHD
Outcome results
None listed