NCT04098055已完成不适用
Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 11-point Numeric Pain Rating Scale
研究概览
简要总结
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or more.
- •Medical diagnosis of LES.
- •Foot involvement.
排除标准
- •Treatment with foot orthoses.
- •LES with acute symptomatic flare.
- •Skin involvement.
- •Neurological problems.
- •Cognitive deterioration.
- •Need for walking assistance.
- •Refused to change footwear to use the foot orthoses.
结局指标
主要结局
11-point Numeric Pain Rating Scale
时间窗: 1 minute
With a range of 0 = no pain to 10 = pain as bad as it can be.
Foot Function
时间窗: 5 minutes
Foot Function Index
Foot Disability
时间窗: 5 minutes
Manchester Foot Pain and Disability Index
SF- 12 Quality of Life
时间窗: 10 minutes
To describe the relationships among functional health status measures. This has values between 0 and 100, with higher values corresponding to lower quality of life.
次要结局
未报告次要终点
研究者
Pedro V. Munuera-Martínez
Director
University of Seville
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Efficacy of customised foot orthoses in the treatment of Achilles tendinopathyAchilles tendinopathyMusculoskeletal - Other muscular and skeletal disordersACTRN12609000829213Shannon Munteanu140
尚未招募
3 期
Foot orthoses for foot pain in people with diabetes and peripheral arterial diseaseFoot painMetabolic and Endocrine - DiabetesCardiovascular - Other cardiovascular diseasesOther - Pain managementPeripheral arterial diseaseDiabetesACTRN12607000300471Podiatry Department, Westmead Hospital60
已完成
不适用
Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and FunctionalityDiabetic Peripheral NeuropathyDiabetes Mellitus, Type 2NCT04605900Universidade do Algarve43
已完成
2 期
The effect of custom-made foot orthoses on low back paiow back pain.Low back painIRCT2015113025308N1Deputy of Research, Tehran University of Medical Sciences62
已完成
不适用
Effect of custom orthoses on foot pain and plantar pressure in pes cavusPes cavusMusculoskeletal DiseasesISRCTN84913516The University of Sydney - School of Physiotherapy (Australia)154