Actively Recruiting

Phase Not Applicable
Age: 18Years - 18Years
All Genders
Healthy Volunteers
NCT07567807

Sensitivity and Tests for Evaluation of Plantar Fasciopathy

Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-05

45

Participants Needed

1

Research Sites

78 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sensitivity and Tests for Evaluation of Plantar Fasciopathy

Who Can Participate

Age: 18Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older with recalcitrant plantar fasciopathy lasting at least 12 months on the surgical waiting list at Clinic I of the Rizzoli Orthopaedic Institute
  • MRI of foot and ankle negative for other local causes of pain in plantar fasciopathy differential diagnosis
  • Negative electromyography for tarsal tunnel syndrome
  • Control participants 18 years or older without foot pain or pathology in the past 12 months, seen at Clinic I for unrelated conditions
Not Eligible

You will not qualify if you...

  • Patients under 18 years of age
  • Patients with diagnosed rheumatologic diseases currently receiving pharmacological treatment
  • Patients with diabetes or diabetic neuropathy
  • Pregnant women

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Istituto ortopedico Rizzoli

Bologna, BO, Italy, 40136

Actively Recruiting

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Research Team

S

Simone Ottavio Zielli, MD

CONTACT

A

Antonio Mazzotti, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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