ESWT in the Treatment of Plantar Fasciitis

June 1, 2026 updated by: Tuğçe Meryem BUCAĞA, Kirsehir Ahi Evran Universitesi

The Effect of ESWT Session Count on Clinical Parameters in the Treatment of Chronic Plantar Fasciitis; Randomized Controlled Study

Extracorporeal shock wave therapy (ESWT) has become widely preferred in Turkey and worldwide in recent years for the treatment of musculoskeletal diseases due to its non-invasive nature, ease of application, and low risk of complications, as it does not require surgical intervention. However, there is no consensus in the literature regarding the energy level used in ESWT applications, the frequency of application, and especially the ideal number of sessions. Different centers apply varying protocols in clinical practice, which can lead to heterogeneity in treatment outcomes. Scientifically determining the effect of variation in the number of ESWT sessions on clinical outcomes is important for establishing standard treatment protocols. Therefore, the aim of our study is to contribute to the existing literature by investigating the effect of variation in the number of ESWT sessions on clinical parameters such as pain, functional status, and quality of life in the treatment of chronic plantar fasciitis, and to develop more effective and evidence-based treatment approaches in patient management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Plantar fasciitis is a common musculoskeletal disorder resulting from a degenerative and inflammatory process of the plantar fascia, which supports the medial longitudinal arch of the foot (Roxas M, 2005). While it affects both sexes, all age groups, and ethnicities, it is more common in women aged 40-60 (Latt LD et al., 2020). The most frequent cause of chronic heel pain, plantar fasciitis typically presents with tenderness on palpation at the medial tubercle of the calcaneus and pain that begins with the first step in the morning (Unuvar BS et al., 2024). This clinical picture can negatively impact patients' daily activities, work capacity, and quality of life, leading to significant functional limitations. The pathophysiology of plantar fasciitis is multifactorial, with mechanical overload, repetitive microtraumas, prolonged standing, obesity, inappropriate footwear, and biomechanical disorders being among the main etiological factors (Avraham D et al., 2025). This process leads to microtears in the plantar fascia, collagen degeneration, and the development of a chronic inflammatory response. Recent histopathological studies, particularly in cases of chronic plantar fasciitis, have revealed that the pathological process is not limited to an inflammatory response but also involves significant degenerative changes. This degenerative process is characterized by disorganization of collagen fibers, increased fibroblast activity, and tissue deterioration. These findings explain why classical anti-inflammatory treatment approaches are insufficient in some patients and the underlying mechanism for limited clinical response (Wearing SC et al., 2006). Diagnosis is usually based on the patient's history and physical examination findings; advanced imaging techniques are typically not required in such cases. Ultrasonography and magnetic resonance imaging can be used in atypical or treatment-resistant cases where differential diagnosis is necessary (Cole C et al., 2005). The first-line approach in treatment is conservative methods. Physical therapy programs including non-steroidal anti-inflammatory drugs, night splints, orthotics, activity modification, and stretching-strengthening exercises are frequently applied (Cole C & Crawford R, 2011) (Garrett TR & Neibert PJ, 2013). However, in approximately 10-20% of patients, symptoms persist for more than six months, developing into chronic plantar fasciitis, and this group requires additional treatment methods. In recent years, minimally invasive methods have gained increasing importance in the treatment of chronic plantar fasciitis. Extracorporeal shock wave therapy (ESWT), being a non-invasive method that does not require surgical intervention, easy to apply, and with a low risk of complications, has become widely preferred in our country and worldwide in the treatment of musculoskeletal diseases in recent years. ESWT is thought to promote tissue healing by increasing local microcirculation, stimulate neovascularization, and provide analgesic effects by modulating pain transmission. It is also believed that ESWT modulates pain transmission and supports regenerative processes in degenerated tissue (Simplicio CL et al., 2020). Clinical studies have reported positive results, particularly in chronic plantar fasciitis cases, in terms of reducing pain intensity, increasing functional capacity, and improving quality of life. Thanks to these properties, ESWT stands out as an effective alternative to surgery in patients who do not respond to conservative treatments (Melese H et al., 2022) (Gerdesmeyer L et al., 2008) (Kudo P et al., 2006). In addition, laser therapy, platelet-rich plasma (PRP) injections, and corticosteroid injections are among other minimally invasive treatment options used (Aleid AM et al., 2025). However, there is no consensus in the literature regarding the energy level used in ESWT applications, the frequency of application, and especially the ideal number of sessions (Park KD et al., 2018). Different centers apply varying protocols in clinical practice, which can lead to heterogeneity in treatment outcomes. Therefore, scientifically determining the effect of the number of ESWT sessions on clinical outcomes is important for establishing standard treatment protocols. In this context, investigating the effect of the number of ESWT sessions on clinical parameters such as pain, functional status, and quality of life in the treatment of chronic plantar fasciitis will contribute to the existing literature and help develop more effective and evidence-based treatment approaches in patient management.

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 (Estimated)

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.
57

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 Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Kırşehir, Turkey (Türkiye)
        • Kırşehir Ahi Evran 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

Yes

Description

Inclusion Criteria:

  • Patients aged 18-65, both male and female, diagnosed with plantar fasciitis based on anamnesis and physical examination.
  • Patients must have had symptoms for at least 3 months.
  • Patients must consent to participate in the study according to the informed consent form.

Exclusion Criteria:

  • Complaint lasting less than 3 months
  • Having received an injection in the heel area within the last 6 months
  • Having applied physical therapy modalities to the heel area within the last 6 months
  • Bilateral complaint
  • Pregnancy
  • Malignancy
  • Epilepsy
  • History of cardiac pacemaker
  • Anticoagulant use
  • History of systemic inflammatory disease
  • History of fracture or surgery in the lower extremity
  • Presence of an open wound in the heel area
  • Hypersensitivity in the patient
  • Systemic infection in the patient
  • Uncontrolled hypertension in the patient
  • Uncontrolled diabetes in the patient
  • Inability of the patient to cooperate
  • History of neuromuscular disease affecting balance parameters
  • Patient's unwillingness to participate in the study

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: Single

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.
Experimental: Group A
ESWT treatment will not be given to this group; instead, exercise therapy will be performed by the patient alone for 3 weeks. Plantar fascia stretching exercises, gastrosoleus stretching exercises, and foot intrinsic muscle strengthening exercises will be taught to the patients by the same physiotherapist with over 5 years of clinical experience and expertise in these areas, and they will be asked to perform these exercises 10 times twice a day for a total of 3 weeks.
Other: Exercise group
exercise
Experimental: Group B
A physiotherapist with over 5 years of clinical experience will apply radial ESWT treatment to the most painful point in the heel area and surrounding soft tissues, targeting the attachment site of the plantar fascia on the medial calcaneus. The treatment will be performed at a frequency of 10 Hz, a pressure of 2.5-3 bar, and 2000 pulses, once a week for a total of 3 sessions. The exercises taught to the exercise group will also be taught to this group, and they will be asked to perform them 10 times twice a day for a total of 3 weeks.
Other: Exercise group
exercise
Other: 3 ESWT sessions
exercise and ESWT
Experimental: Group C
The same physiotherapist, with over 5 years of clinical experience, will apply radial ESWT treatment to the most painful point in the heel area and surrounding soft tissues, targeting the attachment site of the plantar fascia on the medial calcaneus. The treatment will consist of 2000 pulses at a frequency of 10 Hz and a pressure of 2.5-3 bar, once a week for a total of 5 sessions. The exercises taught to the exercise group will also be taught to this group, and they will be instructed to perform them 10 times twice a day for a total of 3 weeks.
Other: Exercise group
exercise
Other: 5 ESWT sessions
exercise and ESWT

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
Measure Description
Time Frame
Visual Analog Scale
Time Frame: baseline, 3th week, 6th week, 12th week
In this scale, pain intensity is generally rated from "absence of pain" (0 points) to "imagined most severe pain" (10 points on a 10-point scale) (Wewers et al., 1990). The pain intensity scoring ranges are: <3 mild pain, 3-6 moderate pain, >6 severe pain. VAS is a widely used and practical scale for chronic pain worldwide.
baseline, 3th week, 6th week, 12th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food Function Index
Time Frame: baseline, 3th week, 6th week, 12th week
The scale consists of 23 items with three subgroups: pain, disability, and activity limitation. The nine-item pain subscale measures the level of foot pain in various situations. The nine-item disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. The five-item activity limitation subscale evaluates activity limitations caused by foot problems.
baseline, 3th week, 6th week, 12th week
Pain Pressure Threshold
Time Frame: baseline, 3th week, 6th week, 12th week
519 It refers to the first point in a tissue where pressure is converted into pain. It is measured with an algometer. The measurement is taken from a predetermined standard anatomical point. In this study, it was planned to measure plantar fasciitis from the medial calcaneal tubercle. The algometer is held vertically, and the pressure is increased at a constant rate. The patient is asked to indicate when the pressure is converted into pain. The value displayed on the device is recorded (in kg/cm2 or Newton-N). Three measurements are taken from the same point. A 60-second waiting period is observed between measurements. The average value is recorded.
baseline, 3th week, 6th week, 12th week
Timed up and go test
Time Frame: baseline, 3th week, 6th week, 12th week
The TUG test is planned to be used to assess the mobility and balance of the participants. During the test, participants are asked to stand up from a chair with a seat height of approximately 45 cm upon the command "Stand up," walk 3 meters, turn around a cone, and then sit back down in the chair. The test duration will be recorded in seconds. The test will be repeated twice, and the average of the two test durations will be calculated and recorded.
baseline, 3th week, 6th week, 12th week
Ultrasound Measurement of Plantar Fascia Thickness
Time Frame: baseline, 3th week, 6th week, 12th week
Ultrasound imaging can be used in the diagnosis of plantar fasciitis, in the exclusion of soft tissue pathologies in the differential diagnosis, and in monitoring treatment. In USG, a plantar fascia thickness greater than 4 mm, or a plantar fascia thickness of 1 mm or more on the symptomatic side compared to the asymptomatic side, increased vascularity in Doppler mode, and the presence of hypoechoic areas in the plantar fascia are important in the diagnosis of PF. In this study, thickness measurements were performed in all groups at week 0 (before treatment) and week 12, with patients in the prone position with the ankle dorsiflexed at 90 degrees, along the longitudinal axis at the attachment point of the plantar fascia to the calcaneus.
baseline, 3th week, 6th week, 12th week

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.
Kirsehir Ahi Evran Universitesi

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: tuğçe meryem bucağa, MD, Kırşehir Ahi Evran Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
July 1, 2026

Primary Completion (Estimated)

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.
February 1, 2027

Study Completion (Estimated)

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.
March 15, 2027

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).
June 1, 2026

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.
June 1, 2026

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.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

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.
June 4, 2026

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.
June 1, 2026

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.
June 1, 2026

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.
  • AhiEvranU-FTR-PF-ESWT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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