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临床试验/NCT07463794
NCT07463794已完成不适用

Plantar Fasiit Tedavisinde ESWT ve Tüm Vücut Vibrasyon Uygulamalarının Etkinliğinin Karşılaştırılması: Randomize, Prospektif, Tek Kör Çalışma

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1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
60
试验地点
1
主要终点
Foot Function Index (FFI)

研究概览

简要总结

Plantar fasciitis is a common cause of heel pain that can lead to functional limitation and decreased quality of life. Various conservative treatment modalities are used in its management. This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and whole body vibration therapy in patients with plantar fasciitis. The study is designed as a randomized, prospective, single-blind clinical trial. Clinical outcomes will be evaluated using pain and functional assessment scales before and after treatment.

详细描述

This randomized, prospective, single-blind clinical trial was conducted to compare the effects of extracorporeal shock wave therapy (ESWT) and whole body vibration therapy in patients diagnosed with plantar fasciitis. A total of 60 patients aged between 18 and 65 years were included in the final analysis. Participants were randomly assigned into two groups.

The first group received extracorporeal shock wave therapy applied once weekly for a total of five sessions. The second group received whole body vibration therapy three times per week for five weeks. Both groups followed the same standardized home exercise program during the treatment period.

Clinical evaluations were performed at baseline, at the end of treatment, and at the ninth week. The primary outcome measure was functional status assessed using the Foot Function Index (FFI). Secondary outcome measures included pain intensity assessed by the Visual Analog Scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) score, and the Roles and Maudsley score.The aim of this study is to determine and compare the clinical effectiveness of ESWT and whole body vibration therapy in the management of plantar fasciitis.

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)

盲法说明

Outcome assessors were blinded to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Clinically diagnosed plantar fasciitis
  • Heel pain lasting at least 4 weeks
  • Ability to understand the study procedures and provide written informed consent

排除标准

  • History of inflammatory rheumatic diseases
  • Previous foot or ankle surgery
  • Major trauma to the foot or ankle
  • Neurological or vascular disorders of the lower extremities
  • Pregnancy or lactation
  • Corticosteroid injection to the foot within the last 3 months
  • Physical therapy, extracorporeal shock wave therapy, or whole body vibration therapy within the last 3 months

研究组 & 干预措施

Extracorporeal Shock Wave Therapy (ESWT)

Experimental

Participants received extracorporeal shock wave therapy once weekly for five sessions.

干预措施: Extracorporeal Shock Wave Therapy (Device)

Whole Body Vibration Therapy

Experimental

Participants received whole body vibration therapy three times per week for five weeks.

干预措施: Whole Body Vibration Therapy (Device)

结局指标

主要结局

Foot Function Index (FFI)

时间窗: Baseline, 5 weeks and 9 weeks

Foot Function Index (FFI), a self-reported questionnaire consisting of 23 items in three subscales (pain, disability, and activity limitation), with scores ranging from 0 to 100. Higher scores indicate worse foot-related disability.

次要结局

  • Visual Analog Scale (VAS)(Baseline, 5 weeks and 9 weeks)
  • American Orthopaedic Foot and Ankle Society Score (AOFAS)(Baseline, 5 weeks and 9 weeks)
  • Roles and Maudsley Score(Baseline, 5 weeks and 9 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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