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ESWT in the Treatment of Plantar Fasciitis

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07626723
Enrollment
57
Registered
2026-06-04
Start date
2026-07-01
Completion date
2027-03-15
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Shock Wave Therapy, Plantar Fasciitis, Ultrasonography

Brief 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. 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.

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.

Interventions

OTHERExercise group

exercise

OTHER3 ESWT sessions

exercise and ESWT

OTHER5 ESWT sessions

exercise and ESWT

Sponsors

Kirsehir Ahi Evran Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scalebaseline, 3th week, 6th week, 12th weekIn 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.

Secondary

MeasureTime frameDescription
Food Function Indexbaseline, 3th week, 6th week, 12th weekThe 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.
Pain Pressure Thresholdbaseline, 3th week, 6th week, 12th week519 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.
Timed up and go testbaseline, 3th week, 6th week, 12th weekThe 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.
Ultrasound Measurement of Plantar Fascia Thicknessbaseline, 3th week, 6th week, 12th weekUltrasound 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTTuğçe Meryem Bucağa, MD
tmbucaga@gmail.com+095445627270
CONTACTNazife Kapan Tunçer, Asst. Prof.
nazifekapan@gmail.com+095555839701
PRINCIPAL_INVESTIGATORtuğçe meryem bucağa, MD

Kırşehir Ahi Evran Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026