Rheumatoid Foot Insole

NCT01546610 | Unknown DMC

• 1 other identifier: 1348/09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid foot; foot pain; insoles; foot function; electronic baropodometer; plantar pressure; gait analysis

Outcome Measures

Primary Outcomes (1)

• 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 (9)

• Foot Function Index (FFI)

  12 months

• Foot Health Status Questionnaire (FHSQ-Br)

  12 months

• Health Assessmente Questionnaire (HAQ)

  12 months

• Visual analog scale of pain in feet at rest (VAS)

  12 months

• 6-MINUTE WALK TEST

  12 months

Study Arms (2)

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

insoles intervention OTHER

EVA insole with arch support and bar retrocapital

Also known as: Interventional group

intervention foot orthoses

placebo insole OTHER

EVA insole flat

Also known as: control group

placebo insole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Emilia Moreira

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• EMILIA MOREIRA, PT

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• ANAMARIA PT JONES, PHD

  Federal University of São Paulo

  STUDY DIRECTOR

• JAMIL NATOUR, PHD

  Division of Rheumatology, Federal University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Emilia Moreira

CONTACT

551125942014; emilia.moreira@hotmail.com

Jamil MD Natour, PHD

CONTACT

551155764239; jnatour@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of rheumatoid foot insole

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

BR (1)