NCT02546115已完成不适用
Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis, a Single-blinded Randomised Controlled Trial
University Hospitals, Leicester1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
研究概览
简要总结
To assess whether the provision of a tension night splint (TNS) device has any additional benefit in patients with chronic plantar fasciitis, compared to routine care comprising physiotherapy & podiatry alone.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age >18 with symptoms of plantar fasciitis for >3 months
- •Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)
排除标准
- •Current or previous partial or full-thickness tear of the Achilles tendon or plantar fascia (either clinically suspected or proven on imaging)
- •Current or previous calf muscle injury
- •Previous use of tension night splint
- •Diabetic neuropathy, or other sensory / sensorimotor disturbance
- •Lower limb vascular compromise
- •Fragile skin, or skin wounds on lower leg
- •Subjects with impaired mobility which prevents safe and effective application of the Tension Night Splint
- •Any other condition which it is thought may be aggravated by the use of a tension night splint
- •Subjects unable to give valid consent for the study
- •Subjects who state that they are unable or unwilling to undergo the home-based structured rehabilitation programme as a part of the study process
- •Subjects who are unable to attend the follow-up appointment required at the end of the study
结局指标
主要结局
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
时间窗: primary outcome time = 3 months
次要结局
- improvement in function as assessed by validated PROMs as described below(3 months - end point)
研究者
研究点 (1)
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