Comparison of the Efficacy of Posterior Tibial Nerve Neuromodulation and Extracorporeal Shock Wave Therapy for Heel Spur: A Randomized Controlled Trial

September 24, 2025 updated by: Halil Ibrahim Altun

Heel pain is an important clinical condition that impairs patients' quality of life and causes loss of workforce. Heel spurs are one of the most important causes of heel pain. Heel spur, often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to microtrauma to the calcaneus following inflammation of the fascia , and over time, an organized bone protrusion called a spur forms in the same area . Plantar in patients with heel spurs It is often accompanied by fasciitis . Heel spurs are more common in women. It increases with increasing age due to mechanical trauma to the heel. Its incidence is not clearly known . In its etiology, age, gender, obesity, foot structure that disrupts biomechanics, rheumatological and metabolic diseases, and trauma come to the fore .

Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs (NSAIDs), other analgesics, exercise, splints and orthoses, shoe insoles and pads, corticosteroid injections into the spur area and extracorporeal shock wave therapy (ESWT). There are a limited number of studies in which pulse radiofrequency (PRF) and injection were applied to the posterior tibial nerve, which senses the region , and conventional or pulse radiofrequency was successfully applied to the lesion area .

ESWT is a non-invasive method. A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation. In ESWT, radial and focal waves are applied depending on the tissue depth. patellar tendinopathy , plantar fasciitis , myositis It is an effective and reliable method that is frequently used in the treatment of ossificans , lateral epicondylitis , iliotibial band syndrome, many tendinopathies and heel spurs .

PRF is a newer neuromodulation method than conventional radiofrequency. It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve , and A-delta and C fibers are affected. algogenic neuromediators decrease, endogenous opioids such as Dynorphin , Enkephalin and Endorphin increase, thus reducing pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will include 48 patients between the ages of 18 and 65, diagnosed with heel spurs, who meet the inclusion and exclusion criteria in the Algology and PMR (Physical medicine and rehabilitation) departments of Kanuni Sultan Süleyman Training and Research Hospital, between sep 2024 and apr 2025 (Standard effect As a result of the power analysis, it was deemed appropriate to include at least 22 cases in each group with a power of 80% and a margin of error of 0.84 . According to this result, a total of 48 patients will be included in the study, taking into account the losses ). Randomization will be done using a randomization program to divide patients into two groups and assign a number to each patient.

The power analysis, it was deemed appropriate to include at least 22 cases in each group , with a standard effect size of 0.84, with 80% power and 5% margin of error . According to this result, a total of 48 patients will be included in the study, taking into account losses .) The posterior tibial nerve will be performed by the same algologist . Patients will be monitored standardly (Noninvasive blood pressure, pulse oximeter, electrocardiogram) and will be performed in the supine position at TCPRF . For TCPRF, a 45*98 mm diameter transcutaneous electrode (FIAB SPA, Italy ) will be used. Electrode medial at ankle level It will be placed posterior to the malleolus , in the posterior tibial nerve trace accompanying the artery after palpation of the posterior tibial artery . TCPRF will be applied for 8 minutes at 80 volts, 2 Hz, 20 ms . The process will be repeated 3 times with a one-week interval.

To the control group with the radial ESWT device. Vibrolith An Orto® brand electro- pneumatic , extracorporeal shock wave therapy device will be used. It will be applied by the same physiotherapist with at least 10 years of experience in the field. Sick It will be in the prone position and ESWT will be applied to the spur area as a radial type shock wave . The process will be repeated 3 times with a one-week interval. Sessions will be applied with 10 Hz frequency, 2000 beats, 2.5 bar intensity.

Patient evaluation and results will be made by another algologist (FAE) who is unaware of the type of treatment. Demographic data of the patients, body mass index (BMI), symptom duration, additional diseases, medical treatments, the side where the procedure was performed, rest and activity Numeric Rating Scale -11 ( NRS) and Foot function index ( Foot ) function index , FFI) will be recorded before the procedure and in the 1st and 3rd months after the procedure. NRS-11 is an 11-point numerical scale in which patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life) . FFI is a validated scale consisting of 23 questions in total, including 3 subgroups : pain, disability and activity limitation .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34000
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-65,
  • Patients diagnosed with calcaneus spur and epin calcaneus in radiological imaging with anamnesis, clinical and physical examination
  • Patients who signed the voluntary consent form

Exclusion Criteria:

  • Patients who have undergone interventional procedures for heel spurs in the last 6 months,
  • Morbidly obese patients (BMI>35 kg/m2),
  • Patients with advanced decompensated heart failure and pacemakers,
  • Patients with known transcutaneous pad allergy, patients with skin infection in the area where ESWT was performed or pads were attached,
  • Patients with metal implants,
  • Patients with circulatory disorders and lesions,
  • Patients who cannot communicate and cannot be positioned,
  • Patients with bleeding disorders, patients with severe psychosis and progressive neurological deficits and muscle diseases,
  • and pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei)
Other: transcutaneous pulsed radiofrequency
Instead of invasive application of PRF directly to the lesion area or nerve, transcutaneous pulsed radiofrequency (TCPRF) is applied noninvasively.
Other: extracorporeal shock wave therapy (ESWT)
Other: extracorporeal shock wave therapy (ESWT)'
A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
foot function index
Time Frame: four months
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halil Ibrahim Altun

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: halil ibrahim altun, specialist, Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • heelspur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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