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临床试验/NCT06813105
NCT06813105已完成不适用

Exploratory Analysis of Pain and Function Improvement After Radial Pressure Wave Therapy in Plantar Fasciitis.

Hospital Civil de Guadalajara1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年11月19日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Pain intensity assessed by the Numerical Pain Rating Scale (NPRS).

研究概览

简要总结

The goal of this observational study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and baseline pain intensity) and clinical outcomes in patients with plantar fasciitis undergoing radial pressure wave therapy (RPWT). The study includes male and female adults aged 18 to 60 years.

详细描述

Background: Plantar fasciitis (PF) is a common cause of heel pain, significantly impairing functionality and quality of life. Radial pressure wave therapy (RPWT) has emerged as a non-invasive therapeutic option. However, there is limited evidence regarding factors that may influence clinical outcomes in patients receiving this treatment.

Objectives: The primary objective of this study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and pain intensity) and clinical outcomes in patients with PF treated with RPWT. Additionally, this study aims to assess changes in pain intensity and functionality following RPWT.

Materials and Methods

This is an exploratory, pilot observational study including patients diagnosed with PF who undergo three sessions of RPWT. The study evaluates changes in pain intensity, assessed using the Numerical Pain Rating Scale (NPRS), and functionality, measured using the WHODAS 2.0. Patient characteristics such as age, body mass index (BMI), and PF chronicity are collected retrospectively from medical records. Statistical analyses will be conducted to examine potential associations between patient characteristics and treatment outcomes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of plantar fasciitis confirmed by clinical evaluation.
  • Age 18 to 60 years.
  • Symptoms persisting for at least three months before treatment.
  • Completed three RPWT sessions using a standardized protocol (2000 impulses per session, 10 Hz, and 3.5 bar).
  • Availability of complete medical records, including three-month follow-up data.

排除标准

  • History of foot surgery or corticosteroid injection in the affected limb within the past six months.
  • Pregnancy at the time of treatment.
  • Presence of concurrent musculoskeletal conditions (e.g., fractures, active infections, sprains) in the affected limb.
  • Diagnosis of systemic conditions (e.g., cancer, osteoporosis, autoimmune diseases).
  • Incomplete medical records or failure to complete RPWT sessions and follow-up visits.

结局指标

主要结局

Pain intensity assessed by the Numerical Pain Rating Scale (NPRS).

时间窗: Immediately after the last RPWT session, approximately 1 week after baseline.

Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS), a validated 10-point scale where 0 represents "no pain" and 10 represents "the worst pain imaginable."

次要结局

  • Functionality assessed by the WHODAS 2.0 scale.(Immediately after the last RPWT session, approximately 1 week after baseline.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Armando Tonatiuh Avila Garcia

Chief Department of Physical Medicine and Rehabilitation

Hospital Civil de Guadalajara

研究点 (1)

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