Rheumatoid Foot Insole | NCT01546610

Studies
Rheumatoid Foot Insole

NCT01546610

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Mar 9, 2012Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Rheumatoid Arthritis

Interventions

insoles intervention
placebo insole

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 2, 2012

First Posted Date

Mar 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2012

Last Update Posted Date

Mar 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emilia Moreira, PT, Effect of rheumatoid foot insole, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention foot orthoses	Experimental	Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital	Other: insoles intervention
placebo insole	Placebo Comparator	Foot orthose with support retrocapital and support of medial arch insole intervention	Other: placebo insole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insoles intervention	Other	EVA insole with arch support and bar retrocapital	intervention foot orthoses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Foot Function Index (FFI)	Function of the foot	12 months
Foot Health Status Questionnaire (FHSQ-Br)	Foot Health Status	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emilia Moreira	Contact	551125942014		emilia.moreira@hotmail.com
Jamil MD Natour, PHD	Contact	551155764239		jnatour@unifesp.br

Overall Officials

Name	Affiliation	Role
EMILIA MOREIRA, PT	Federal University of São Paulo	Principal Investigator
ANAMARIA PT JONES, PHD	Federal University of São Paulo	Study Director
JAMIL NATOUR, PHD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emilia Moreira	Recruiting	São Paulo	São Paulo		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided