Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Item Pain of the KOOS Score
研究概览
简要总结
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.
A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.
The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.
Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 12-40 years
- •Patellofemoral pain syndrome
- •Patient affiliated to a social protection regime
- •Patient who signed an informed consent
- •For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months
- •Patient informed of the results of the prior medical examination
- •Normality (no sign of osteoarthritis) of the knee radiographs
- •Ability to read and understand French
排除标准
- •Knee osteoarthritis
- •Systemic disease
- •Inflammatory rheumatism disease
- •Unstable knee
- •Prior patellofemoral dislocation
- •Osteochondrosis
- •Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers)
- •A history of patellar trauma
- •A history of knee surgery
- •Meniscus, ligament or osteochondral pathology
- •Knee tendinitis or bursitis
- •Neurologic disease
- •Pregnancy
- •Antidepressant therapy or behavioral disorder
- •Patient unable to comply the required maximum observance
- •Impossibility to give enlightened information to the patient
- •Patient under guardianship
结局指标
主要结局
Item Pain of the KOOS Score
时间窗: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
次要结局
- KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)(Twice : at inclusion and at 10 weeks follow-up with feet orthoses)
- Kujala Score(Twice : at inclusion and at 10 weeks follow-up with feet orthoses)
- Pain level(Twice : at inclusion and at 10 weeks follow-up with feet orthoses)