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临床试验/NCT00650884
NCT00650884已完成不适用

Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

Dynasplint Systems, Inc.7 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
7
主要终点
Change in Foot Ankle Pain Disability Survey scores

研究概览

简要总结

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).

详细描述

To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:
  • Pain on the bottom of the heel
  • Pain that is usually worse upon arising or after long periods of non weight bearing
  • Pain that increases over a period of months
  • Pain is worsened by walking barefoot on hard surfaces or by walking up stairs
  • Morning mobility limitations
  • Preference of patients to "walk on their toes"
  • Paresthesias after non weight bearing (while sitting or lying down or both)
  • Nocturnal pain
  • Patients must be willing and able to sign the informed consent

排除标准

  • Achilles tendon injury
  • Acute traumatic rupture of the plantar fascia
  • Calcaneal bursitis
  • Calcaneal neuritis
  • Calcaneal stress fracture
  • Lumbosacral radiculopathy of S1 nerve root
  • Retrocalcaneal bursitis
  • Tarsal tunnel syndrome

结局指标

主要结局

Change in Foot Ankle Pain Disability Survey scores

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (7)

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