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Status unknownNCT01546610Updated Mar 9, 2012

Rheumatoid Foot Insole

An interventional study of insoles intervention and placebo insole in Rheumatoid Arthritis, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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).

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid foot
  • foot pain
  • insoles
  • foot function
  • electronic baropodometer
  • plantar pressure
  • gait analysis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 80 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    intervention foot orthoses

    Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital

    Other: insoles intervention

  • Placebo comparator
    placebo insole

    Foot orthose with support retrocapital and support of medial arch insole intervention

    Other: placebo insole

Interventions

  • Otherinsoles intervention

    EVA insole with arch support and bar retrocapital

    Also known as: Interventional group

  • Otherplacebo insole

    EVA insole flat

    Also known as: control group

06

What researchers measure

Primary outcomes

  1. 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

  1. Foot Function Index (FFI)

    Function of the foot

    Time frame: 12 months

  2. Foot Health Status Questionnaire (FHSQ-Br)

    Foot Health Status

    Time frame: 12 months

  3. Health Assessmente Questionnaire (HAQ)

    Functional capacity assessed by HAQ in rheumatoid arthritis

    Time frame: 12 months

  4. 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

  5. 6-MINUTE WALK TEST

    Assess functional capacity

    Time frame: 12 months

  6. Shorth Form-36 (SF-36)

    Quality of life by SF-36

    Time frame: 12 months

  7. LIKERT SCALE

    Likert scale by patients

    Time frame: 12 months

  8. TESTS BAROPODOMETRIC

    Evaluates charge distribution in the feet and gait variables

    Time frame: 12 months

  9. TIME USE OF INSOLE

    Control the use of time insole

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01546610
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Emilia Moreira, PT (Effect of rheumatoid foot insole, Federal University of São Paulo) — Principal investigator
First posted
Mar 7, 2012
Start date
Nov 2011
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Mar 9, 2012

Study contacts

Emilia Moreira
Contact
emilia.moreira@hotmail.com
551125942014
Jamil MD Natour, PHD
Contact
jnatour@unifesp.br
551155764239
EMILIA MOREIRA, PT
principal investigator · Federal University of São Paulo
ANAMARIA PT JONES, PHD
study director · Federal University of São Paulo
JAMIL NATOUR, PHD
study chair · Division of Rheumatology, Federal University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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