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临床试验/NCT01588730
NCT01588730终止4 期

Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Dynasplint Systems, Inc.2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年6月最近更新:
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适应症

试验速览

阶段
4 期
状态
终止
入组人数
26
试验地点
2
主要终点
FFI score
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •All patients will have had a history of at least 3 consecutive months of plantar heel pain well-localized to the plantar fascia.
  • •All patients will have failed an initial treatment of non-weight bearing plantar and Achilles stretching.
  • •Diagnosis will be confirmed by physical examination by a single physician (JPF) with a typical point of maximum tenderness over the medial tubercle of the calcaneus

排除标准

  • •rheumatoid arthritis
  • •local infection
  • •pregnancy
  • •patients with tumors
  • •unresolved fractures
  • •severe peripheral vascular disease
  • •history of prior plantar fascia surgery
  • •history of plantar fascia rupture
  • •age <18 years
  • •recent ( within 6 weeks) steroid injection

结局指标

主要结局

FFI score

时间窗: 16 weeks

The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score

次要结局

  • Pain subscale and SROM questionnaire(2, 4 and 12 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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