Clinical trial NCT01546610: Rheumatoid Foot Insole
Official title: Effect of Rheumatoid Foot Insole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid foot
foot pain
insoles
foot function
electronic baropodometer
plantar pressure
gait analysis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-03-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Visual analog scale of pain in feet during walking (VAS)
timeFrame: 12 months
Secondary outcomes:
measure: Foot Function Index (FFI)
timeFrame: 12 months
measure: Foot Health Status Questionnaire (FHSQ-Br)
timeFrame: 12 months
measure: Health Assessmente Questionnaire (HAQ)
timeFrame: 12 months
measure: Visual analog scale of pain in feet at rest (VAS)
timeFrame: 12 months
measure: 6-MINUTE WALK TEST
timeFrame: 12 months
measure: Shorth Form-36 (SF-36)
timeFrame: 12 months
measure: LIKERT SCALE
timeFrame: 12 months
measure: TESTS BAROPODOMETRIC
timeFrame: 12 months
measure: TIME USE OF INSOLE
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Emilia Moreira
Study officials:
affiliation: Federal University of São Paulo
name: EMILIA MOREIRA, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: ANAMARIA PT JONES, PHD
role: STUDY_DIRECTOR
affiliation: Division of Rheumatology, Federal University of Sao Paulo
name: JAMIL NATOUR, PHD
role: STUDY_CHAIR
References: