NCT07567807 Sensitivity and Tests for Evaluation of Plantar Fasciopathy
| NCT ID | NCT07567807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Plantar Fasciitis, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-04-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * PF and control groups: * Minor patients * Patients with diagnosed rheumatologic diseases currently under pharmacological treatment * Patients with diabetes or diabetic neuropathy * Pregnant women
Contact & Investigator
Simone Ottavio Zielli, MD
PRINCIPAL INVESTIGATOR
IRCCS Istituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT07567807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 18 Years, studying Plantar Fasciitis, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07567807 currently recruiting?
Yes, NCT07567807 is actively recruiting participants. Contact the research team at simoneottavio.zielli@ior.it for enrollment information.
Where is the NCT07567807 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07567807 clinical trial?
NCT07567807 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Simone Ottavio Zielli, MD at IRCCS Istituto Ortopedico Rizzoli. The trial plans to enroll 45 participants.