ESWT in the Treatment of Plantar Fasciitis
2026年6月1日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
57
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Tuğçe Meryem Bucağa, MD
- 電話番号:+095445627270
- メール:tmbucaga@gmail.com
研究連絡先のバックアップ
- 名前:Nazife Kapan Tunçer, Asst. Prof.
- 電話番号:+095555839701
- メール:nazifekapan@gmail.com
研究場所
-
-
-
Kırşehir、トルコ(Türkiye)
- Kırşehir Ahi Evran Training and Research Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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
|
|
実験的: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
|
|
実験的: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Visual Analog Scale
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Food Function Index
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:tuğçe meryem bucağa, MD、Kırşehir Ahi Evran Training and Research Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年3月15日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。