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临床试验/NCT07567807
NCT07567807招募中不适用

Sensitivity and Tests for Evaluation of Plantar Fasciopathy

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1

研究概览

简要总结

Plantar fasciopathy (PF), one of the leading causes of foot pain, affects up to one in ten individuals in their lifetime. Characterized by pain and structural alterations at the proximal insertion of the plantar fascia on the calcaneus, the term "PF" has replaced "plantar fasciitis," as degenerative tissue changes predominate over inflammatory processes.

The pathogenesis of PF remains incompletely understood but appears to involve the gastrocnemius muscle, which is part of an integrated biomechanical unit including the calcaneus and the plantar fascia. Diagnosis is primarily based on clinical history and physical examination, while imaging modalities such as ultrasound and magnetic resonance imaging assist in excluding differential diagnoses. A simple clinical test to distinguish PF from other causes of heel pain, such as plantar fat pad syndrome or Baxter's nerve entrapment, could improve diagnostic efficiency.

Given the biomechanical relationship between the Achilles tendon and the plantar fascia, and their shared association with gastrocnemius tightness, a clinical test adapted from Achilles tendon assessment may be useful for diagnosing PF. In 2003, the Royal London Hospital proposed a diagnostic approach for Achilles tendinopathy based on pain reduction during active ankle dorsiflexion, which reduces tension in the tendon. The same concept could be applied, with appropriate modifications, to PF.

The present study aims to evaluate the sensitivity, specificity, reproducibility, and predictive value of localized tenderness at the medial calcaneal tuberosity and of a modified version of the Royal London Hospital Test in patients with PF. Secondarily, it will assess the reproducibility and prevalence of the Silfverskiöld test, supporting the concept of a biomechanical unit involving the triceps surae, calcaneus, and plantar fascia.

Aim of this study is to evaluate the sensitivity, specificity, reproducibility, and predictive value of tenderness at the medial calcaneal tuberosity and of a modified version of the Royal London Hospital Test in patients presenting with clinical signs of PF. The modified version of the Royal London Hospital Test for PF has not yet been formally validated in the literature. However, the study was designed following the methodology adopted by Prof. Maffulli for the validation of the original test. Therefore, this is an exploratory study aimed at collecting preliminary data on this new diagnostic test. The secondary objectives of this study is to evaluate the reproducibility and prevalence of the Silfverskiöld test in the study population.

详细描述

Plantar fasciopathy (PF) is one of the most common causes of foot pain, affecting a substantial proportion of the population במהלך their lifetime. It is characterized by pain and structural alterations at the proximal insertion of the plantar fascia on the calcaneus. The term "plantar fasciopathy" is preferred over "plantar fasciitis," as degenerative tissue changes and thickening are considered to predominate over inflammatory processes.

The pathogenesis of PF remains incompletely understood but is thought to involve the gastrocnemius muscle within an integrated biomechanical unit that includes the triceps surae complex, the calcaneus, and the plantar fascia. PF has a relevant clinical and socioeconomic impact, affecting quality of life and functional capacity, particularly in individuals exposed to prolonged standing or weight-bearing activities. Although most patients respond to conservative treatment, a subset develops persistent or refractory symptoms.

Diagnosis is primarily clinical, based on patient history and physical examination. Imaging modalities such as ultrasound and magnetic resonance imaging are mainly used to exclude alternative causes of heel pain. However, the relationship between imaging findings and symptom severity remains inconsistent, and there is currently no simple, standardized clinical test with established diagnostic accuracy for PF. The availability of a reliable bedside test capable of distinguishing PF from other causes of heel pain would improve diagnostic efficiency and clinical decision-making.

Given the anatomical and biomechanical relationship between the Achilles tendon and the plantar fascia, and their shared association with gastrocnemius tightness, adapting a clinical test originally developed for Achilles tendon assessment may provide a useful diagnostic approach. A method based on pain modification during active ankle dorsiflexion, which alters mechanical tension, may be transferable to the plantar fascia with appropriate modification.

This study is designed as an exploratory diagnostic investigation aimed at evaluating the performance of two clinical assessments: localized tenderness at the medial calcaneal tuberosity and a modified version of the Royal London Hospital Test adapted for PF. The study focuses on assessing diagnostic accuracy in terms of sensitivity, specificity, reproducibility, and predictive values in patients presenting with clinical signs consistent with PF. The modified test has not yet undergone formal validation, and this investigation is intended to provide preliminary evidence regarding its clinical applicability.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

MD performing the diagnostic tests are not aware if the participant has PF or not.

入排标准

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

入选标准

  • PF group:
  • Patients on the waiting list at Clinic I of the Rizzoli Orthopaedic Institute for surgical intervention with a diagnosis of recalcitrant PF lasting at least 12 months
  • Age >18 years
  • MRI of the foot and ankle negative for other local causes of pain included in the differential diagnosis of PF
  • Negative electromyography for tarsal tunnel syndrome
  • Control group:
  • Age >18 years
  • Outpatients followed at Clinic I for conditions unrelated to the foot and ankle, with no clinical history of foot pain or pathology in the preceding 12 months

排除标准

  • PF and control groups:
  • Minor patients
  • Patients with diagnosed rheumatologic diseases currently under pharmacological treatment
  • Patients with diabetes or diabetic neuropathy
  • Pregnant women

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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