Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads in People With Central Metatarsalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale
研究概览
简要总结
Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.
详细描述
Metatarsalgia is a common condition that affecting about 10% of the general population. Central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. This randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years;
- •Complain of foot pain on the 2nd to 4th MTPJs during walking in shoes, rating the pain intensity as ≥ 50mm on the Visual Analogue Scale (VAS);
- •Able to be ambulant
排除标准
- •Peripheral vascular disease (PVD)
- •Neurological dysfunctions or neuromuscular disorders
- •Active infection, i.e., cellulitis, osteomyelitis, shingles
- •Cognitive impairment
- •History of lower limb surgery and currently undergoing rehabilitation
- •Active ulceration on foot and ankle
- •Current utilization of prescribed insoles
结局指标
主要结局
Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale
时间窗: Baseline, a follow-up at 4-8 weeks from baseline
VAS consists of a 100mm-long uninterrupted horizontal line, with 2 verbal description at each end. A score of 0mm represents "no pain" while 100 mm represents "the worst imaginable pain".
次要结局
- Foot and Ankle Outcome Score (FAOS)(Baseline, a follow-up at 4-8 weeks from baseline)
- Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints(Baseline, a follow-up at 4-8 weeks from baseline)
研究者
Chan Fung Ting
Student
Chinese University of Hong Kong