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临床试验/NCT07383558
NCT07383558招募中不适用

Does Targeting the Sural Nerve in Addition to the Posterior Tibial Nerve Increase the Effectiveness of Pulsed Radiofrequency Treatment in Chronic Plantar Heel Pain?

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年6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
招募中
入组人数
48
试验地点
1
主要终点
VAS

研究概览

简要总结

This observational study aims to compare the effectiveness of pulsed radiofrequency (PRF) treatment applied to the posterior tibial nerve alone versus PRF applied to both the posterior tibial and sural nerves in patients with chronic plantar heel pain. Outcomes will be assessed using the Visual Analog Scale (VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score at baseline, 1 month, and 3 months after treatment.

详细描述

This prospective observational cohort study evaluates whether the addition of sural nerve pulsed radiofrequency (PRF) to posterior tibial nerve PRF is associated with greater clinical improvement in patients with chronic plantar heel pain. In routine clinical practice, ultrasound-guided PRF is applied to the posterior tibial nerve, and in selected patients, additional PRF of the sural nerve is performed based on clinical judgment.

Patients are prospectively followed in two groups according to the treatment received: posterior tibial nerve PRF alone and posterior tibial nerve PRF combined with sural nerve PRF. Clinical outcomes are assessed at baseline and at 1 and 3 months after the procedure. Pain intensity is evaluated using the Visual Analog Scale (VAS), and functional outcome is assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score. Changes in these outcomes are compared between the two groups during the follow-up period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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
  • Presence of chronic plantar heel pain
  • Baseline VAS score >5

排除标准

  • History of foot fracture or tumor
  • Coagulopathy or use of antiplatelet therapy
  • Cognitive impairment preventing informed consent

研究组 & 干预措施

Posterior tibial + sural nerve PRF

Patients with chronic plantar heel pain who received ultrasound-guided pulsed radiofrequency treatment applied to both the posterior tibial nerve and the sural nerve as part of routine clinical care.

干预措施: Pulsed radiofrequency (Procedure)

Posterior tibial nerve PRF

Patients with chronic plantar heel pain who received ultrasound-guided pulsed radiofrequency treatment applied only to the posterior tibial nerve as part of routine clinical care.

干预措施: Pulsed radiofrequency (Procedure)

结局指标

主要结局

VAS

时间窗: Baseline, 1 month, and 3 months post-procedure

Visual Analog Scale (VAS) is a simple tool used in clinical trials to measure pain intensity. Patients rate their pain on a scale, typically from 0 (no pain) to 10 (worst imaginable pain). It provides a quick, quantitative assessment of subjective pain and is commonly used to evaluate treatment effectiveness before and after intervention.Change in pain intensity assessed by Visual Analog Scale (VAS)

次要结局

  • AOFAS(Baseline, 1 month, and 3 months post-procedure)

研究者

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

Damla Yürük

Supervisor Investigator

Diskapi Teaching and Research Hospital

研究点 (1)

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