Plantar FasciitisNCT07006389
Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Study
An observational study of Plantar Fasciitis and Plantar Heel Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Heel pain is a problem that affects daily life activities and quality of life. Extracorporeal shock wave therapy (ESWT) is a treatment used for heel pain. However, some people do not benefit from ESWT treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Plantar Heel Pain
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 15 Jul 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a history of plantar fasciitis
Who may be able to join
- >18 years
- Unresponsive to conservative treatments (physical therapy, rest, exercises, anti-inflammatory medical treatment, insoles, etc.)
- Patients who have received ESWT treatment and 3-6 months have passed since ESWT
Who cannot join
- History of injection therapy including steroids after ESWT treatment
- Those taking NSAIDs in the last 2 weeks
- Those with a history of trauma or surgery to the foot or ankle
- Presence of rheumatic disease affecting the foot or ankle (e.g. spondyloarthritis, etc.)
- Malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Heel pain is a problem that affects daily life activities and quality of life. Extracorporeal shock wave therapy (ESWT) is a treatment used for heel pain. However, some people do not benefit from ESWT treatment. The aim of this study is to determine the factors that affect the response to ESWT in the treatment of heel pain.
Read the detailed description
Plantar heel pain is one of the reasons that affect daily life activities. There are many treatment methods for this. Extracorporeal shock wave therapy (ESWT) is one of them. However, some patients do not respond to ESWT treatment. In this study, patients were divided into 2 groups as those who did not respond to ESWT treatment in terms of pain (less than 50% decrease in pain level) or those with recurrence of pain and those who responded to treatment. Patients who had passed 3-6 months after ESWT constituted the study groups. These two groups will be compared in terms of age, gender, occupation, weight, height, Body Mass Index (BMI), side: right / left / bilateral, calcaneal angle, Meary angle, presence of spur on X-ray (size in mm if present), dorsiflexion angle degree, plantar fascia thickness with ultrasonography, tibial / plantar nerve conduction study evaluated with electroneuromyography, Visual Analog Scale, Heel Sensitivity Index and Foot Function Index.
- Conditions
- Plantar Fasciitis, Plantar Heel Pain
- Keywords
- pain, plantar fasciitis, plantar heel pain, ESWT, extracorporeal shock wave therapy
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-responder group to ESWT | Patients who had less than 50% response in the Visual Analog Scale (VAS) after ESWT and patients who had >50% VAS regression in the first month after ESWT and whose pain recurred afterwards | |
| Responder group to ESWT | Patients who had >50% VAS regression in the 6th month were included in the group that responded to ESWT treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcaneal inclination angle
This angle is established on a weight-bearing lateral foot radiograph between the calcaneal inclination axis (i.e., the lowest portion of the calcaneus) and the supporting horizontal surface. A cut-off point of ≤19° is used to diagnose symptomatic pes planus/flatfoot.
Measured: Day 1
Ankle dorsiflexion degree
The patient is in a prone position with the ankle on the test side away from the base and the leg extended. The therapist will stabilize the tibia. The normal range of ankle dorsiflexion is 20 degrees. Normal plantar flexion is 50 degrees.
Measured: Day 1
Plantar fascia thickness
To be measured by ultrasound; typically shows increased fascial thickness (>4.0 mm) and a hypoechoic fascia.
Measured: Day 1
Tibial/plantar nerve conduction study with electroneuromyography
Nerve conductions show decreased amplitude of the compound muscle action potential (CMAP) of the tibial nerve stimulated at the ankle and recorded from the abductor hallucis and abductor digiti minimi. Sensory and mixed conduction studies are usually performed with centering techniques.
Measured: Day 1
Secondary outcomes (4)
Meary angle
The Meary angle has been used to determine the apex of the deformity on lateral weight-bearing foot radiographs in patients with pes cavus and pes planus. It is the angle between a line drawn through the longitudinal axes of the talus (mid-talus axis) and the first metatarsal (first metatarsal axis). It can be used to classify the severity of the deformity; mild: <15º, moderate: 15-30º, severe: >30º
Measured: Day 1
Plantar calcaneal spurs
Classically, on plain radiography, the presence of a bony spur extending inferomedially from the calcaneus in the sagittal image will be determined, and its size in mm will be determined.
Measured: Day 1
Heel Tenderness index
0=no pain; 1=painful; 2=painful and whines; 3=painful, whines, and withdraws
Measured: Day 1
Foot Function Index
The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability, and activity limitation in patients. Pain, disability, and activity limitation subscale scores range from 0 to 100.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Banu Kuran, Professor, MD, Study director, Şişli Hamidiye Etfal Taining and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006389
- Sponsor's protocol ID
- 12.31.2024/approval no:4684
- Status last verified
- Oct 2026
- First submitted
- 27 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Response to Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Cross-sectional Clinical Study
- ClinicalTrials.gov ID
- NCT07006389
- Acronym / sponsor ID
- 12.31.2024/approval no:4684
- Conditions
- Plantar Fasciitis, Plantar Heel Pain
- Keywords
- pain, plantar fasciitis, plantar heel pain, ESWT, extracorporeal shock wave therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heel pain is a problem that affects daily life activities and quality of life. Extracorporeal shock wave therapy (ESWT) is a treatment used for heel pain. However, some people do not benefit from ESWT treatment. The aim of this study is to determine the factors that affect the response to ESWT in the treatment of heel pain.
Detailed description
Plantar heel pain is one of the reasons that affect daily life activities. There are many treatment methods for this. Extracorporeal shock wave therapy (ESWT) is one of them. However, some patients do not respond to ESWT treatment. In this study, patients were divided into 2 groups as those who did not respond to ESWT treatment in terms of pain (less than 50% decrease in pain level) or those with recurrence of pain and those who responded to treatment. Patients who had passed 3-6 months after ESWT constituted the study groups. These two groups will be compared in terms of age, gender, occupation, weight, height, Body Mass Index (BMI), side: right / left / bilateral, calcaneal angle, Meary angle, presence of spur on X-ray (size in mm if present), dorsiflexion angle degree, plantar fascia thickness with ultrasonography, tibial / plantar nerve conduction study evaluated with electroneuromyography, Visual Analog Scale, Heel Sensitivity Index and Foot Function Index.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-responder group to ESWT | – | –Patients who had less than 50% response in the Visual Analog Scale (VAS) after ESWT and patients who had >50% VAS regression in the first month after ESWT and whose pain recurred afterwards |
| Responder group to ESWT | – | –Patients who had >50% VAS regression in the 6th month were included in the group that responded to ESWT treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of plantar fasciitis
Key inclusion criteria (3 listed)
- >18 years
- Unresponsive to conservative treatments (physical therapy, rest, exercises, anti-inflammatory medical treatment, insoles, etc.)
- Patients who have received ESWT treatment and 3-6 months have passed since ESWT
Key exclusion criteria (6 listed)
- History of injection therapy including steroids after ESWT treatment
- Those taking NSAIDs in the last 2 weeks
- Those with a history of trauma or surgery to the foot or ankle
- Presence of rheumatic disease affecting the foot or ankle (e.g. spondyloarthritis, etc.)
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calcaneal inclination angle
Time frame: Day 1
This angle is established on a weight-bearing lateral foot radiograph between the calcaneal inclination axis (i.e., the lowest portion of the calcaneus) and the supporting horizontal surface. A cut-off point of ≤19° is used to diagnose symptomatic pes planus/flatfoot.
Ankle dorsiflexion degree
Time frame: Day 1
The patient is in a prone position with the ankle on the test side away from the base and the leg extended. The therapist will stabilize the tibia. The normal range of ankle dorsiflexion is 20 degrees. Normal plantar flexion is 50 degrees.
Plantar fascia thickness
Time frame: Day 1
To be measured by ultrasound; typically shows increased fascial thickness (>4.0 mm) and a hypoechoic fascia.
Tibial/plantar nerve conduction study with electroneuromyography
Time frame: Day 1
Nerve conductions show decreased amplitude of the compound muscle action potential (CMAP) of the tibial nerve stimulated at the ankle and recorded from the abductor hallucis and abductor digiti minimi. Sensory and mixed conduction studies are usually performed with centering techniques.
4 secondary outcomes
Meary angle
Time frame: Day 1
Plantar calcaneal spurs
Time frame: Day 1
Heel Tenderness index
Time frame: Day 1
Foot Function Index
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Plantar Fasciitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banu Kuran, Professor, MD study director
Şişli Hamidiye Etfal Taining and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fasciitis and Plantar Heel Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcaneal inclination angle (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.