Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Algometry
研究概览
简要总结
The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.
It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed radiologically with calcaneal osteochondritis
- •diagnosed radiologically with calcaneal osteochondritis
- •have signed informed consent
排除标准
- •had suffered some trauma on the heel in the past 2 months
- •had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
- •had presented physical or neurological impairment
- •were not interested
结局指标
主要结局
Algometry
时间窗: At baseine and after the intervention period
Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention
Visual analogical scale (VAS)
时间窗: At baseine and after the intervention period
Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS)
Sport activity pain perception
时间窗: At baseine and after the intervention period
Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention
次要结局
- Foot Posture Index (FPI)(At baseline)
- lunge test values(At baseline)