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

Tracking Information

First Received Date ^ICMJE

March 2, 2012

Last Updated Date

March 8, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01546610 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Rheumatoid Foot Insole

Official Title ^ICMJE

Effect of Rheumatoid Foot Insole

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).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01546610

Other Study ID Numbers ^ICMJE

1348/09

Has Data Monitoring Committee

Yes

Responsible Party

Emilia Moreira, PT, Federal University of São Paulo

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

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

Information Provided By

Federal University of São Paulo

Verification Date

March 2012

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

To Top