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Rheumatoid Foot Insole

This study is currently recruiting participants.
Verified March 2012 by Federal University of São Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Emilia Moreira, PT, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01546610
First received: March 2, 2012
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention
Rheumatoid Arthritis
 Other: insoles intervention
Other: placebo insole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Rheumatoid Foot Insole

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Visual analog scale of pain in feet during walking (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)


Secondary Outcome Measures:
  • Foot Function Index (FFI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Function of the foot

  • Foot Health Status Questionnaire (FHSQ-Br) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Foot Health Status

  • Health Assessmente Questionnaire (HAQ) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Functional capacity assessed by HAQ in rheumatoid arthritis

  • Visual analog scale of pain in feet at rest (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Assessing pain in the feet at rest through a visual analog scale from 0 to 10

  • 6-MINUTE WALK TEST [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Assess functional capacity

  • Shorth Form-36 (SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Quality of life by SF-36

  • LIKERT SCALE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Likert scale by patients

  • TESTS BAROPODOMETRIC [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluates charge distribution in the feet and gait variables

  • TIME USE OF INSOLE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Control the use of time insole


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention foot orthoses
Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital
 Other: insoles intervention
EVA insole with arch support and bar retrocapital
Other Name: Interventional group
Placebo Comparator: placebo insole
Foot orthose with support retrocapital and support of medial arch insole intervention
 Other: placebo insole
EVA insole flat
Other Name: control group

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546610

Contacts
Contact: Emilia Moreira 551125942014 emilia.moreira@hotmail.com
Contact: Jamil MD Natour, PHD 551155764239 jnatour@unifesp.br

Locations
Brazil
Emilia Moreira Recruiting
Sao Paulo, Brazil
Contact: Emilia PT Moreira     551125942014     emilia.moreira@hotmail.com    
Contact: Jamil MD Natour, PHD     551155764239     jnatour@unifesp.br    
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: EMILIA MOREIRA, PT Federal University of Sao Paulo
Study Director: ANAMARIA PT JONES, PHD Federal University of Sao Paulo
Study Chair: JAMIL NATOUR, PHD Division of Rheumatology, Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Emilia Moreira, PT, Effect of rheumatoid foot insole, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01546610     History of Changes
Other Study ID Numbers: 1348/09
Study First Received: March 2, 2012
Last Updated: March 8, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Rheumatoid foot
foot pain
insoles
foot function
 electronic baropodometer
plantar pressure
gait analysis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013