Effect of Rheumatoid Foot Insole
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual analog scale of pain in feet during walking (VAS)
研究概览
简要总结
The present study aims to evaluate the effect of insoles for foot arthritis.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Visual analog scale of pain in feet during walking (VAS)
时间窗: 12 months
Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)
次要结局
- 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)
- Shorth Form-36 (SF-36)(12 months)
- LIKERT SCALE(12 months)
- TESTS BAROPODOMETRIC(12 months)
- TIME USE OF INSOLE(12 months)
研究者
Emilia Moreira, PT
Effect of rheumatoid foot insole
Federal University of São Paulo