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临床试验/NCT06356064
NCT06356064已完成不适用

Investigation of The Effectiveness of Extracorporeal Shock Wave Therapy in Patients Diagnosed With Epin Calcanei: Comparison of Radial and Focus Applications

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Functional Foot Index

研究概览

简要总结

Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.

Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.

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 (Participant)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presence of heel pain for at least four weeks,
  • •Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
  • •Agreed to participate in the study.

排除标准

  • •History of fracture or surgery,
  • •Polyneuropathy,
  • •Rheumatological diseases,
  • •Coagulation disorders,
  • •Thrombosis,
  • •Soft tissue or bone infection,
  • •Pregnancy and lactation,
  • •Epilepsy,
  • •Presence of a pacemaker.

研究组 & 干预措施

rESWT( Radial Extracorporeal shock wave therapy)

Experimental

rESWT(2.4 bar, 12 hz, 2000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks

干预措施: Extracorporeal shock wave therapy (Device)

fESWT(Focused Extracorporeal shock wave therapy))

Experimental

fESWT (0.14 bar, 14 hz, 1000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks

干预措施: Extracorporeal shock wave therapy (Device)

结局指标

主要结局

Functional Foot Index

时间窗: Before and after treatment baseline, 4th week, 12 th week

0 is no pain 10 is max pain, and 0 is no deficiency 10 is the maximum deficiency and 0 is no activity limitation 10 is the maximum activity limitation score.

Visual Analog Scale

时间窗: Before and after treatment baseline, 4th week, 12 th week

0 min , 10 is maximum pain score

次要结局

  • Radiographic assesment, epin size(Before and after treatment baseline, 4th week, 12 th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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