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ESWT in the Treatment of Plantar Fasciitis

1 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

57

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Tuğçe Meryem Bucağa, MD
  • Numer telefonu: +095445627270
  • E-mail: tmbucaga@gmail.com

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

      • Kırşehir, Turcja (Türkiye)
        • Kırşehir Ahi Evran Training and Research Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
exercise
Eksperymentalny: 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.
exercise
exercise and ESWT
Eksperymentalny: 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.
exercise
exercise and ESWT

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Visual Analog Scale
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Food Function Index
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2027

Ukończenie studiów (Szacowany)

15 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • AhiEvranU-FTR-PF-ESWT

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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