ESWT in the Treatment of Plantar Fasciitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKirsehir Ahi Evran Universitesi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise group
Other interventionexercise
3 ESWT sessions
Other interventionexercise and ESWT
5 ESWT sessions
Other interventionexercise and ESWT
Treatment groups
57 Participants
are divided into 3 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Visual Analog Scale
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.
Time frame
baseline, 3th week, 6th week, 12th weekSecondary outcomes
1
Food Function Index
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.
Time frame
baseline, 3th week, 6th week, 12th week2
Pain Pressure Threshold
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.
Time frame
baseline, 3th week, 6th week, 12th week3
Timed up and go test
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.
Time frame
baseline, 3th week, 6th week, 12th week4
Ultrasound Measurement of Plantar Fascia Thickness
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.
Time frame
baseline, 3th week, 6th week, 12th weekSponsors and contacts
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Source ClinicalTrials.gov
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