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Plantar FasciitisNCT07626723

ESWT in the Treatment of Plantar Fasciitis

A study testing Exercise group, 3 ESWT sessions and 5 ESWT sessions in people with Plantar Fasciitis and Extracorporeal Shock Wave Therapy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Exercise group, 3 ESWT sessions and 5 ESWT sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2026to 15 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tuğçe Meryem Bucağa, MD contact

+095445627270

tmbucaga@gmail.com

Nazife Kapan Tunçer, Asst. Prof. contact

+095555839701

nazifekapan@gmail.com

Turkey (Türkiye)1 site
  • Kırşehir Ahi Evran Training and Research Hospital

    Kırşehir

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Exercise group, 3 ESWT sessions, 5 ESWT sessions
Medical subject headings
Fasciitis, Plantar

What participants receive

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

  • Exercise groupOther

    exercise

  • 3 ESWT sessionsOther

    exercise and ESWT

  • 5 ESWT sessionsOther

    exercise and ESWT

Study groups in NCT07626723
Study groupRoleWhat they receive
Group AExperimentalESWT 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.
Receives: Other: Exercise group
Group BExperimentalA 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.
Receives: Other: Exercise group; Other: 3 ESWT sessions
Group CExperimentalThe 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.
Receives: Other: Exercise group; Other: 5 ESWT sessions

What is being measured

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

  1. Visual Analog Scale

    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.

    Measured: baseline, 3th week, 6th week, 12th week

Secondary outcomes (4)
  1. Food Function Index

    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.

    Measured: baseline, 3th week, 6th week, 12th week

  2. Pain Pressure Threshold

    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.

    Measured: baseline, 3th week, 6th week, 12th week

  3. Timed up and go test

    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.

    Measured: baseline, 3th week, 6th week, 12th week

  4. Ultrasound Measurement of Plantar Fascia Thickness

    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.

    Measured: baseline, 3th week, 6th week, 12th week

Timeline

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

  1. First posted4 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07626723
Sponsor's protocol ID
AhiEvranU-FTR-PF-ESWT
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
4 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Avraham D, Sokolov R, Arieli I, Stav O, Herman A, Oulianski M. [PLANTAR FASCIOPATHY - DIAGNOSIS AND TREATMENT]. Harefuah. 2025 Feb;164(2):103-107. Hebrew.

    PubMed 39987479
  • Aleid AM, Alyabis NA, Aldanyowi SN, Albinsaad LS, AlAidarous HA, Aleid ZM, AlMutair AS. Efficacy of platelet-rich plasma versus corticosteroid injections in recovery from plantar fasciitis: A systematic review and meta-analysis. J Taibah Univ Med Sci. 2025 Feb 25;20(1):120-128. doi: 10.1016/j.jtumed.2025.01.002. eCollection 2025 Feb.

    PubMed 40092568

Questions about this trial

What is this clinical trial studying?

A study testing Exercise group, 3 ESWT sessions and 5 ESWT sessions in people with Plantar Fasciitis and Extracorporeal Shock Wave Therapy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

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 3 inclusion and 19 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: opening soon, as of the sponsor's last update on 4 Jun 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 Turkey (Türkiye). 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Tuğçe Meryem Bucağa, MD (+095445627270, tmbucaga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: baseline, 3th week, 6th week, 12th week). 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 NCT07626723, which also lists 2 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 4 Jun 2026.

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