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Rheumatoid Foot Insole

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
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

March 2, 2012
March 8, 2012
November 2011
November 2012   (final data collection date for primary outcome measure)
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)
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
Complete list of historical versions of study NCT01546610 on ClinicalTrials.gov Archive Site
  • 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
  • FFI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Function of the foot
  • FHSQ-Br [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Foot Health Status
  • 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
  • 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
Not Provided
Not Provided
 
Rheumatoid Foot Insole
Effect of Rheumatoid Foot Insole

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

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Other: insoles intervention
    EVA insole with arch support and bar retrocapital
    Other Name: Interventional group
  • Other: placebo insole
    EVA insole flat
    Other Name: control group
  • Experimental: intervention foot orthoses
    Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital
    Intervention: Other: insoles intervention
  • Placebo Comparator: placebo insole
    Foot orthose with support retrocapital and support of medial arch insole intervention
    Intervention: Other: placebo insole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Emilia Moreira 551125942014 emilia.moreira@hotmail.com
Contact: Jamil MD Natour, PHD 551155764239 jnatour@unifesp.br
Brazil
 
NCT01546610
1348/09
Yes
Emilia Moreira, PT, Federal University of São Paulo
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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
Federal University of São Paulo
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP