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Rheumatoid Foot Insole

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
insoles intervention
placebo insole
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid foot, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Emilia MoreiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention foot orthoses

placebo insole

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 2, 2012
Last Updated
March 8, 2012
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01546610
Brief Title
Rheumatoid Foot Insole
Official Title
Effect of Rheumatoid Foot Insole
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid foot, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention foot orthoses
Arm Type
Experimental
Arm Description
Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital
Arm Title
placebo insole
Arm Type
Placebo Comparator
Arm Description
Foot orthose with support retrocapital and support of medial arch insole intervention
Intervention Type
Other
Intervention Name(s)
insoles intervention
Other Intervention Name(s)
Interventional group
Intervention Description
EVA insole with arch support and bar retrocapital
Intervention Type
Other
Intervention Name(s)
placebo insole
Other Intervention Name(s)
control group
Intervention Description
EVA insole flat
Primary Outcome Measure Information:
Title
Visual analog scale of pain in feet during walking (VAS)
Description
Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Foot Function Index (FFI)
Description
Function of the foot
Time Frame
12 months
Title
Foot Health Status Questionnaire (FHSQ-Br)
Description
Foot Health Status
Time Frame
12 months
Title
Health Assessmente Questionnaire (HAQ)
Description
Functional capacity assessed by HAQ in rheumatoid arthritis
Time Frame
12 months
Title
Visual analog scale of pain in feet at rest (VAS)
Description
Assessing pain in the feet at rest through a visual analog scale from 0 to 10
Time Frame
12 months
Title
6-MINUTE WALK TEST
Description
Assess functional capacity
Time Frame
12 months
Title
Shorth Form-36 (SF-36)
Description
Quality of life by SF-36
Time Frame
12 months
Title
LIKERT SCALE
Description
Likert scale by patients
Time Frame
12 months
Title
TESTS BAROPODOMETRIC
Description
Evaluates charge distribution in the feet and gait variables
Time Frame
12 months
Title
TIME USE OF INSOLE
Description
Control the use of time insole
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilia Moreira
Phone
551125942014
Email
emilia.moreira@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jamil MD Natour, PHD
Phone
551155764239
Email
jnatour@unifesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIA MOREIRA, PT
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ANAMARIA PT JONES, PHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
JAMIL NATOUR, PHD
Organizational Affiliation
Division of Rheumatology, Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Emilia Moreira
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilia PT Moreira
Phone
551125942014
Email
emilia.moreira@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jamil MD Natour, PHD
Phone
551155764239
Email
jnatour@unifesp.br

12. IPD Sharing Statement

Learn more about this trial

Rheumatoid Foot Insole

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