Rheumatoid Foot Insole

Rheumatoid Arthritis Clinical Trial

Official title:

Effect of Rheumatoid Foot Insole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01546610
• Other study ID #: 1348/09
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2012
• Last updated: March 8, 2012
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2012
• Source: Federal University of São Paulo
• Contact: Emilia Moreira
• Phone: 551125942014
• Email: emilia.moreira[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• insoles intervention
EVA insole with arch support and bar retrocapital
• placebo insole
EVA insole flat

Locations

Country	Name	City	State
Brazil	Emilia Moreira	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Foot Function Index (FFI)	Function of the foot	12 months	Yes
Secondary	Foot Health Status Questionnaire (FHSQ-Br)	Foot Health Status	12 months	Yes
Secondary	Health Assessmente Questionnaire (HAQ)	Functional capacity assessed by HAQ in rheumatoid arthritis	12 months	Yes
Secondary	Visual analog scale of pain in feet at rest (VAS)	Assessing pain in the feet at rest through a visual analog scale from 0 to 10	12 months	Yes
Secondary	6-MINUTE WALK TEST	Assess functional capacity	12 months	Yes
Secondary	Shorth Form-36 (SF-36)	Quality of life by SF-36	12 months	Yes
Secondary	LIKERT SCALE	Likert scale by patients	12 months	Yes
Secondary	TESTS BAROPODOMETRIC	Evaluates charge distribution in the feet and gait variables	12 months	Yes
Secondary	TIME USE OF INSOLE	Control the use of time insole	12 months	Yes