AzTrials
AzTrials

Plantar Fasciitis, ChronicSTEPNCT07567807

Sensitivity and Tests for Evaluation of Plantar Fasciopathy

A study testing Gastroc Sign, Tenderness at the Medial Calcaneal Tuberosity and Silfverskiöld Test in people with Plantar Fasciitis, Chronic, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Plantar Fasciitis, Chronic
What is being tested?
Gastroc Sign, Tenderness at the Medial Calcaneal Tuberosity and Silfverskiöld Test
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteItaly
Study dates
1 Apr 2025to 22 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Istituto ortopedico Rizzoli

    Bologna, BO, 40136

Other trials in Italy

About this study

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.

Read more

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.

Read the detailed description

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.

In addition, the study explores the role of gastrocnemius tightness within the proposed biomechanical framework by assessing the reproducibility and prevalence of the Silfverskiöld test in the same population.

The study adopts a controlled design with blinded assessment by multiple examiners under standardized conditions. Repeated evaluations within the same day are performed to assess intra- and inter-observer reliability. This methodological approach is intended to ensure robustness in the evaluation of diagnostic performance and to minimize measurement bias.

Overall, the study aims to contribute to the development and validation of simple, clinically applicable diagnostic tools for plantar fasciopathy, with potential implications for improving early diagnosis and optimizing patient management.

Being tested
Gastroc Sign, Tenderness at the Medial Calcaneal Tuberosity, Silfverskiöld Test
Keywords
plantar fasciopathy, Silfverskiöld test
Medical subject headings
Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastroc SignDiagnostic 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.

  • Tenderness at the Medial Calcaneal TuberosityDiagnostic 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.

  • Silfverskiöld TestDiagnostic 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.

Study groups in NCT07567807
Study groupRoleWhat they receive
PF groupExperimental* 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
Receives: Diagnostic Test: Gastroc Sign; Diagnostic Test: Tenderness at the Medial Calcaneal Tuberosity; Diagnostic Test: Silfverskiöld Test
Control groupSham 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
Receives: Diagnostic Test: Gastroc Sign; Diagnostic Test: Tenderness at the Medial Calcaneal Tuberosity; Diagnostic Test: Silfverskiöld Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from the morning to the afternoon of Day 1 - baseline

  2. 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.

    Measured: from the morning to the afternoon of Day 1 - baseline

  3. 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.

    Measured: from the morning to the afternoon of Day 1 - baseline

  4. 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.

    Measured: from the morning to the afternoon of Day 1 - baseline

Secondary outcomes (1)
  1. Reproducibility of the Silfverskiöld Test

    To assess the inter- and intra-rater reliability of the Silfverskiöld test in the study population, determining its consistency as a clinical measure of gastrocnemius tightness.

    Measured: from the morning to the afternoon of Day 1 - baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start1 Apr 2025
  3. Primary completion30 Aug 2026
  4. Study completion22 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567807
Sponsor's protocol ID
100/2025/Sper/IOR
Acronym
STEP
Status last verified
Nov 2026
First submitted
21 Apr 2026
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23386760
  • 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.

    PubMed 29198141
  • 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.

    PubMed 30237906

Questions about this trial

What is this clinical trial studying?

A study testing Gastroc Sign, Tenderness at the Medial Calcaneal Tuberosity and Silfverskiöld Test in people with Plantar Fasciitis, Chronic, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sensitivity (time frame: from the morning to the afternoon of Day 1 - baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567807, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in