Sensitivity and Tests for Evaluation of Plantar Fasciopathy

NCT07567807 | Recruiting

• 1 other identifier: 100/2025/Sper/IOR
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis, Chronic

Keywords

plantar fasciopathy; Silfverskiöld test

Outcome Measures

Primary Outcomes (4)

• sensitivity

  To evaluate the ability of tenderness at the medial calcaneal tuberosity and the modified Royal London Hospital Test to correctly identify patients with plantar fasciopathy (true positive rate). Sensitivity reflects the proportion of individuals with PF who are accurately detected by the test.

  from the morning to the afternoon of Day 1 - baseline

• Specificity

  To assess the ability of the same clinical tests to correctly identify individuals without plantar fasciopathy (true negative rate). Specificity represents the proportion of non-PF subjects who are correctly classified as negative.

  from the morning to the afternoon of Day 1 - baseline

• Reproducibility (Reliability)

  To determine the consistency of the test results when performed by different evaluators (inter-rater reliability) and when repeated by the same evaluator at different time points (intra-rater reliability). This will be quantified using statistical measures such as Cohen's kappa coefficient.

  from the morning to the afternoon of Day 1 - baseline

• Predictive Value

  To evaluate the clinical usefulness of the tests in practice: Positive Predictive Value (PPV): the probability that a subject with a positive test result truly has PF. Negative Predictive Value (NPV): the probability that a subject with a negative test result truly does not have PF. These measures depend on disease prevalence and will be recalibrated accordingly.

  from the morning to the afternoon of Day 1 - baseline

Secondary Outcomes (1)

• Reproducibility of the Silfverskiöld Test

  from the morning to the afternoon of Day 1 - baseline

Study Arms (2)

PF group

EXPERIMENTAL

* 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

Diagnostic Test: Gastroc Sign; Diagnostic Test: Tenderness at the Medial Calcaneal Tuberosity; Diagnostic Test: Silfverskiöld Test

Control group

SHAM COMPARATOR

* 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

Diagnostic Test: Gastroc Sign; Diagnostic Test: Tenderness at the Medial Calcaneal Tuberosity; Diagnostic Test: Silfverskiöld Test

Interventions

Gastroc Sign DIAGNOSTIC_TEST

Modified Version of the Royal London Hospital Test (Gastroc Sign) After identifying tenderness at the medial calcaneal tuberosity with the ankle in a neutral or slightly plantarflexed position, participants are asked to actively perform ankle dorsiflexion and plantarflexion with the knee extended. If the tenderness identified in the initial phase decreases or disappears during active dorsiflexion, the test is considered positive.

Control group; PF group

Tenderness at the Medial Calcaneal Tuberosity DIAGNOSTIC_TEST

Palpation is performed with the ankle in a neutral position or slight plantarflexion, gently pressing the medial aspect of the plantar heel region starting from the palpable medial calcaneal tuberosity. Participants are asked to report whether tenderness is present or absent.

Control group; PF group

Silfverskiöld Test DIAGNOSTIC_TEST

The Silfverskiöld test \[20\] is performed with the patient in the supine position. The examiner uses both hands: one stabilizes and locks the subtalar joint in a neutral position, while the other stabilizes the midtarsal joint and forefoot in supination, ensuring that movement is isolated to the tibiotalar joint. Tibiotalar dorsiflexion is measured under two conditions: * With the knee fully extended * With the knee flexed at 90 degrees Limited dorsiflexion in both positions indicates soleus tightness or a bony block as the cause of stiffness. Reduced dorsiflexion with the knee extended, accompanied by a soft and elastic end-feel, suggests isolated gastrocnemius contracture and is therefore interpreted as a positive Silfverskiöld test.

Control group; PF group

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

Related Publications (3)

• Bolivar YA, Munuera PV, Padillo JP. Relationship between tightness of the posterior muscles of the lower limb and plantar fasciitis. Foot Ankle Int. 2013 Jan;34(1):42-8. doi: 10.1177/1071100712459173.

  PMID: 23386760 BACKGROUND

• Nakale NT, Strydom A, Saragas NP, Ferrao PNF. Association Between Plantar Fasciitis and Isolated Gastrocnemius Tightness. Foot Ankle Int. 2018 Mar;39(3):271-277. doi: 10.1177/1071100717744175. Epub 2017 Dec 4.

  PMID: 29198141 BACKGROUND

• Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug.

  PMID: 30237906 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Simone Ottavio Zielli, MD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Ottavio Zielli, MD

CONTACT

+393493858593; simoneottavio.zielli@ior.it

Antonio Mazzotti, MD, PhD

CONTACT

+390516366828; antonio.mazzotti@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: MD performing the diagnostic tests are not aware if the participant has PF or not.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 5, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)