跳至主要内容
临床试验/NCT07006389
NCT07006389Enrolling By Invitation不适用

Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
128
试验地点
1
主要终点
Plantar fascia thickness

研究概览

简要总结

Heel pain is a problem that affects daily life activities and quality of life. Extracorporeal shock wave therapy (ESWT) is a treatment used for heel pain. However, some people do not benefit from ESWT treatment. The aim of this study is to determine the factors that affect the response to ESWT in the treatment of heel pain.

详细描述

Plantar heel pain is one of the reasons that affect daily life activities. There are many treatment methods for this. Extracorporeal shock wave therapy (ESWT) is one of them. However, some patients do not respond to ESWT treatment. In this study, patients were divided into 2 groups as those who did not respond to ESWT treatment in terms of pain (less than 50% decrease in pain level) or those with recurrence of pain and those who responded to treatment. Patients who had passed 3-6 months after ESWT constituted the study groups. These two groups will be compared in terms of age, gender, occupation, weight, height, Body Mass Index (BMI), side: right / left / bilateral, calcaneal angle, Meary angle, presence of spur on X-ray (size in mm if present), dorsiflexion angle degree, plantar fascia thickness with ultrasonography, tibial / plantar nerve conduction study evaluated with electroneuromyography, Visual Analog Scale, Heel Sensitivity Index and Foot Function Index.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • •>18 years
  • •Unresponsive to conservative treatments (physical therapy, rest, exercises, anti-inflammatory medical treatment, insoles, etc.)
  • •Patients who have received ESWT treatment and 3-6 months have passed since ESWT

排除标准

  • •History of injection therapy including steroids after ESWT treatment
  • •Those taking NSAIDs in the last 2 weeks
  • •Those with a history of trauma or surgery to the foot or ankle
  • •Presence of rheumatic disease affecting the foot or ankle (e.g. spondyloarthritis, etc.)
  • •Malignancy
  • •Pregnancy

结局指标

主要结局

Plantar fascia thickness

时间窗: Day 1

To be measured by ultrasound; typically shows increased fascial thickness (\>4.0 mm) and a hypoechoic fascia.

Tibial/plantar nerve conduction study with electroneuromyography

时间窗: Day 1

Nerve conductions show decreased amplitude of the compound muscle action potential (CMAP) of the tibial nerve stimulated at the ankle and recorded from the abductor hallucis and abductor digiti minimi. Sensory and mixed conduction studies are usually performed with centering techniques.

Calcaneal inclination angle

时间窗: Day 1

This angle is established on a weight-bearing lateral foot radiograph between the calcaneal inclination axis (i.e., the lowest portion of the calcaneus) and the supporting horizontal surface. A cut-off point of ≤19° is used to diagnose symptomatic pes planus/flatfoot.

Ankle dorsiflexion degree

时间窗: Day 1

The patient is in a prone position with the ankle on the test side away from the base and the leg extended. The therapist will stabilize the tibia. The normal range of ankle dorsiflexion is 20 degrees. Normal plantar flexion is 50 degrees.

次要结局

  • Heel Tenderness index(Day 1)
  • Meary angle(Day 1)
  • Plantar calcaneal spurs(Day 1)
  • Foot Function Index(Day 1)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Çiftci

Medical Doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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