Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change from Baseline Active graph (bracelet) at 3 months
研究概览
简要总结
Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the interaction between inflammation and abnormal biomechanical. These cause instability in the hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar forefoot and more pain during daily activities. Non-pharmacological interventions (insole, footwear) have an important role, reducing pain and disability, increasing the effectiveness and improving daily activities.
详细描述
Randomized double-blind clinical trial. Two samples of patients will be taken: the control group, which will consist of patients with rheumatoid arthritis and standardized insoles, and other group, which will consist of patients with rheumatoid arthritis and insoles made with direct adaptation technique (TAD) and patients with rheumatoid arthritis and insoles made with an scanner (CAD-CAM). The variables that the investigators will measure are: age, sex, study level, current occupation, rheumatoid arthritis evolution time, quality of life and physical function, pain and health level and general function of the foot. The investigators will use: an accelerometer, and questionnaires: Foot and Ankle Ability Measures (FAAM), Manchester foot pain and disability index (MFPDI), Medical outcomes study short form-36 (SF-36) y Foot Function Index (FFI). This study will analyze patients in the Universities of Malaga and Salford for 6 months.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years of age
- •To meet the criteria of American College of Rheumatology
- •History of bilateral subtalar and/or ankle and/or talonavicular pain
- •Informed consent
- •Normal range of motions at the ankle, subtalar, and midtarsal joints.
排除标准
- •Concomitant musculoskeletal disease
- •Central or peripheral nervous system disease
- •Endocrine disorders, especially diabetes mellitus with a level of insufficient foot sensitivity
- •Patients with a history of orthopedic foot surgery
- •Those currently using foot orthoses.
- •Patients with foot trauma in the last 6 months previous to the study
- •Vascular diseases affecting the foot, active synovitis and edema.
- •Normal daily walking aids will be not permitted.
结局指标
主要结局
Change from Baseline Active graph (bracelet) at 3 months
时间窗: one week, one month and three months
This outcome will be measured with an activity monitor, accelerometer
次要结局
- Change from Baseline quality of life at 3 months(one week, one month and three months)
- Change from Baseline pain intensity at 3 months(one week, one month and three months)
- Change from Baseline foot function 3 months(one week, one month and three months)
- Change from Baseline physical activity at 3 months(one week, one month and three months)
研究者
Gabriel Gijon-Nogueron
Principal Investigator
University of Malaga