- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07626723
ESWT in the Treatment of Plantar Fasciitis
2026년 6월 1일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
57
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Tuğçe Meryem Bucağa, MD
- 전화번호: +095445627270
- 이메일: tmbucaga@gmail.com
연구 연락처 백업
- 이름: Nazife Kapan Tunçer, Asst. Prof.
- 전화번호: +095555839701
- 이메일: nazifekapan@gmail.com
연구 장소
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Kırşehir, 터키 (Türkiye)
- Kırşehir Ahi Evran Training and Research Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analog Scale
기간: baseline, 3th week, 6th week, 12th week
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Food Function Index
기간: baseline, 3th week, 6th week, 12th week
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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
기간: 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
기간: baseline, 3th week, 6th week, 12th week
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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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: tuğçe meryem bucağa, MD, Kırşehir Ahi Evran Training and Research Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 2월 1일
연구 완료 (추정된)
2027년 3월 15일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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