- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07626723
ESWT in the Treatment of Plantar Fasciitis
1. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
57
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tuğçe Meryem Bucağa, MD
- Telefonnummer: +095445627270
- E-post: tmbucaga@gmail.com
Studer Kontakt Backup
- Navn: Nazife Kapan Tunçer, Asst. Prof.
- Telefonnummer: +095555839701
- E-post: nazifekapan@gmail.com
Studiesteder
-
-
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Kırşehir, Tyrkia (Türkiye)
- Kırşehir Ahi Evran Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
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exercise
|
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Eksperimentell: 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.
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exercise
exercise and ESWT
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Eksperimentell: 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.
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exercise
exercise and ESWT
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analog Scale
Tidsramme: 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.
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baseline, 3th week, 6th week, 12th week
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Food Function Index
Tidsramme: 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.
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baseline, 3th week, 6th week, 12th week
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Pain Pressure Threshold
Tidsramme: baseline, 3th week, 6th week, 12th week
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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.
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baseline, 3th week, 6th week, 12th week
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Timed up and go test
Tidsramme: 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.
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baseline, 3th week, 6th week, 12th week
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Ultrasound Measurement of Plantar Fascia Thickness
Tidsramme: baseline, 3th week, 6th week, 12th week
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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.
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baseline, 3th week, 6th week, 12th week
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: tuğçe meryem bucağa, MD, Kırşehir Ahi Evran Training and Research Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. februar 2027
Studiet fullført (Antatt)
15. mars 2027
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AhiEvranU-FTR-PF-ESWT
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