Rheumatoid Foot Insole

Federal University of São Paulo

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Other: placebo insole; Other: insoles intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01546610

1348/09

Details and patient eligibility

About

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

Full 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).

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

intervention foot orthoses

Experimental group

Description:

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

Treatment:

Other: insoles intervention

placebo insole

Placebo Comparator group

Description:

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

Treatment:

Other: placebo insole