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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Tuğçe Meryem Bucağa, MD
- Numero di telefono: +095445627270
- Email: tmbucaga@gmail.com
Backup dei contatti dello studio
- Nome: Nazife Kapan Tunçer, Asst. Prof.
- Numero di telefono: +095555839701
- Email: nazifekapan@gmail.com
Luoghi di studio
-
-
-
Kırşehir, Turchia (Türkiye)
- Kırşehir Ahi Evran Training and Research Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Visual Analog Scale
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Food Function Index
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: tuğçe meryem bucağa, MD, Kırşehir Ahi Evran Training and Research Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- AhiEvranU-FTR-PF-ESWT
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .