Pain, ChronicNCT06558552
Comparison of the Efficacy of Posterior Tibial Nerve Neuromodulation and Extracorporeal Shock Wave Therapy for Heel Spur: A Randomized Controlled Trial
A study testing transcutaneous pulsed radiofrequency and extracorporeal shock wave therapy (ESWT)' in people with Pain, Chronic, run by Halil Ibrahim Altun at 1 site in Turkey (Türkiye).
Trial summary
Heel pain is an important clinical condition that impairs patients' quality of life and causes loss of workforce. Heel spurs are one of the most important causes of heel pain. Heel spur, often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- transcutaneous pulsed radiofrequency and extracorporeal shock wave therapy (ESWT)'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Apr 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65,
- Patients diagnosed with calcaneus spur and epin calcaneus in radiological imaging with anamnesis, clinical and physical examination
- Patients who signed the voluntary consent form
Who cannot join
- Patients who have undergone interventional procedures for heel spurs in the last 6 months,
- Morbidly obese patients (BMI>35 kg/m2),
- Patients with advanced decompensated heart failure and pacemakers,
- Patients with known transcutaneous pad allergy, patients with skin infection in the area where ESWT was performed or pads were attached,
- Patients with metal implants,
- Patients with circulatory disorders and lesions,
Show all 9Show fewer
- Patients who cannot communicate and cannot be positioned,
- Patients with bleeding disorders, patients with severe psychosis and progressive neurological deficits and muscle diseases,
- and pregnant women.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 34000
About this study
Heel pain is an important clinical condition that impairs patients' quality of life and causes loss of workforce. Heel spurs are one of the most important causes of heel pain. Heel spur, often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to microtrauma to the calcaneus following inflammation of the fascia , and over time, an organized bone protrusion called a spur forms in the same area . Plantar in patients with heel spurs It is often accompanied by fasciitis . Heel spurs are more common in women. It increases with increasing age due to mechanical trauma to the heel. Its incidence is not clearly known . In its etiology, age, gender, obesity, foot structure that disrupts biomechanics, rheumatological and metabolic diseases, and trauma come to the fore .
Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs (NSAIDs), other analgesics, exercise, splints and orthoses, shoe insoles and pads, corticosteroid injections into the spur area and extracorporeal shock wave therapy (ESWT). There are a limited number of studies in which pulse radiofrequency (PRF) and injection were applied to the posterior tibial nerve, which senses the region , and conventional or pulse radiofrequency was successfully applied to the lesion area .
Read more
ESWT is a non-invasive method. A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation. In ESWT, radial and focal waves are applied depending on the tissue depth. patellar tendinopathy , plantar fasciitis , myositis It is an effective and reliable method that is frequently used in the treatment of ossificans , lateral epicondylitis , iliotibial band syndrome, many tendinopathies and heel spurs .
PRF is a newer neuromodulation method than conventional radiofrequency. It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve , and A-delta and C fibers are affected. algogenic neuromediators decrease, endogenous opioids such as Dynorphin , Enkephalin and Endorphin increase, thus reducing pain.
Read the detailed description
The study will include 48 patients between the ages of 18 and 65, diagnosed with heel spurs, who meet the inclusion and exclusion criteria in the Algology and PMR (Physical medicine and rehabilitation) departments of Kanuni Sultan Süleyman Training and Research Hospital, between sep 2024 and apr 2025 (Standard effect As a result of the power analysis, it was deemed appropriate to include at least 22 cases in each group with a power of 80% and a margin of error of 0.84 . According to this result, a total of 48 patients will be included in the study, taking into account the losses ). Randomization will be done using a randomization program to divide patients into two groups and assign a number to each patient.
The power analysis, it was deemed appropriate to include at least 22 cases in each group , with a standard effect size of 0.84, with 80% power and 5% margin of error . According to this result, a total of 48 patients will be included in the study, taking into account losses .) The posterior tibial nerve will be performed by the same algologist . Patients will be monitored standardly (Noninvasive blood pressure, pulse oximeter, electrocardiogram) and will be performed in the supine position at TCPRF . For TCPRF, a 45*98 mm diameter transcutaneous electrode (FIAB SPA, Italy ) will be used. Electrode medial at ankle level It will be placed posterior to the malleolus , in the posterior tibial nerve trace accompanying the artery after palpation of the posterior tibial artery . TCPRF will be applied for 8 minutes at 80 volts, 2 Hz, 20 ms . The process will be repeated 3 times with a one-week interval.
To the control group with the radial ESWT device. Vibrolith An Orto® brand electro- pneumatic , extracorporeal shock wave therapy device will be used. It will be applied by the same physiotherapist with at least 10 years of experience in the field. Sick It will be in the prone position and ESWT will be applied to the spur area as a radial type shock wave . The process will be repeated 3 times with a one-week interval. Sessions will be applied with 10 Hz frequency, 2000 beats, 2.5 bar intensity.
Patient evaluation and results will be made by another algologist (FAE) who is unaware of the type of treatment. Demographic data of the patients, body mass index (BMI), symptom duration, additional diseases, medical treatments, the side where the procedure was performed, rest and activity Numeric Rating Scale -11 ( NRS) and Foot function index ( Foot ) function index , FFI) will be recorded before the procedure and in the 1st and 3rd months after the procedure. NRS-11 is an 11-point numerical scale in which patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life) . FFI is a validated scale consisting of 23 questions in total, including 3 subgroups : pain, disability and activity limitation .
- Conditions
- Pain, Chronic
- Being tested
- transcutaneous pulsed radiofrequency, extracorporeal shock wave therapy (ESWT)'
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous pulsed radiofrequencyOther
Instead of invasive application of PRF directly to the lesion area or nerve, transcutaneous pulsed radiofrequency (TCPRF) is applied noninvasively.
extracorporeal shock wave therapy (ESWT)'Other
A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei) | Other | Not described Receives: Other: transcutaneous pulsed radiofrequency |
| extracorporeal shock wave therapy (ESWT) | Other | Not described Receives: Other: extracorporeal shock wave therapy (ESWT)' |
What is being measured
The primary outcome is the main question the study is designed to answer.
foot function index
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024
- Primary completion20 Nov 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halil Ibrahim Altun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- halil ibrahim altun, specialist, Principal investigator, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558552
- Sponsor's protocol ID
- heelspur
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Posterior Tibial Nerve Neuromodulation and Extracorporeal Shock Wave Therapy for Heel Spur: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06558552
- Acronym / sponsor ID
- heelspur
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Halil Ibrahim AltunUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 16 Aug 2024 (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 an important clinical condition that impairs patients' quality of life and causes loss of workforce. Heel spurs are one of the most important causes of heel pain. Heel spur, often plantar fascia calcaneus It is seen at the site of attachment to the tuberosity and is plantar It develops secondary to microtrauma to the calcaneus following inflammation of the fascia , and over time, an organized bone protrusion called a spur forms in the same area . Plantar in patients with heel spurs It is often accompanied by fasciitis . Heel spurs are more common in women. It increases with increasing age due to mechanical trauma to the heel. Its incidence is not clearly known . In its etiology, age, gender, obesity, foot structure that disrupts biomechanics, rheumatological and metabolic diseases, and trauma come to the fore .
Nonsteroids in the treatment of heel spurs There are treatment options such as anti-inflammatory drugs (NSAIDs), other analgesics, exercise, splints and orthoses, shoe insoles and pads, corticosteroid injections into the spur area and extracorporeal shock wave therapy (ESWT). There are a limited number of studies in which pulse radiofrequency (PRF) and injection were applied to the posterior tibial nerve, which senses the region , and conventional or pulse radiofrequency was successfully applied to the lesion area .
ESWT is a non-invasive method. A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation. In ESWT, radial and focal waves are applied depending on the tissue depth. patellar tendinopathy , plantar fasciitis , myositis It is an effective and reliable method that is frequently used in the treatment of ossificans , lateral epicondylitis , iliotibial band syndrome, many tendinopathies and heel spurs .
PRF is a newer neuromodulation method than conventional radiofrequency. It increases c-fos gene expression at the cellular level in neurons without causing destructive damage to the nerve , and A-delta and C fibers are affected. algogenic neuromediators decrease, endogenous opioids such as Dynorphin , Enkephalin and Endorphin increase, thus reducing pain.
Detailed description
The study will include 48 patients between the ages of 18 and 65, diagnosed with heel spurs, who meet the inclusion and exclusion criteria in the Algology and PMR (Physical medicine and rehabilitation) departments of Kanuni Sultan Süleyman Training and Research Hospital, between sep 2024 and apr 2025 (Standard effect As a result of the power analysis, it was deemed appropriate to include at least 22 cases in each group with a power of 80% and a margin of error of 0.84 . According to this result, a total of 48 patients will be included in the study, taking into account the losses ). Randomization will be done using a randomization program to divide patients into two groups and assign a number to each patient.
The power analysis, it was deemed appropriate to include at least 22 cases in each group , with a standard effect size of 0.84, with 80% power and 5% margin of error . According to this result, a total of 48 patients will be included in the study, taking into account losses .) The posterior tibial nerve will be performed by the same algologist . Patients will be monitored standardly (Noninvasive blood pressure, pulse oximeter, electrocardiogram) and will be performed in the supine position at TCPRF . For TCPRF, a 45*98 mm diameter transcutaneous electrode (FIAB SPA, Italy ) will be used. Electrode medial at ankle level It will be placed posterior to the malleolus , in the posterior tibial nerve trace accompanying the artery after palpation of the posterior tibial artery . TCPRF will be applied for 8 minutes at 80 volts, 2 Hz, 20 ms . The process will be repeated 3 times with a one-week interval.
To the control group with the radial ESWT device. Vibrolith An Orto® brand electro- pneumatic , extracorporeal shock wave therapy device will be used. It will be applied by the same physiotherapist with at least 10 years of experience in the field. Sick It will be in the prone position and ESWT will be applied to the spur area as a radial type shock wave . The process will be repeated 3 times with a one-week interval. Sessions will be applied with 10 Hz frequency, 2000 beats, 2.5 bar intensity.
Patient evaluation and results will be made by another algologist (FAE) who is unaware of the type of treatment. Demographic data of the patients, body mass index (BMI), symptom duration, additional diseases, medical treatments, the side where the procedure was performed, rest and activity Numeric Rating Scale -11 ( NRS) and Foot function index ( Foot ) function index , FFI) will be recorded before the procedure and in the 1st and 3rd months after the procedure. NRS-11 is an 11-point numerical scale in which patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life) . FFI is a validated scale consisting of 23 questions in total, including 3 subgroups : pain, disability and activity limitation .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei) | Other | Other: transcutaneous pulsed radiofrequency |
| extracorporeal shock wave therapy (ESWT) | Other | Other: extracorporeal shock wave therapy (ESWT)' |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65,
- Patients diagnosed with calcaneus spur and epin calcaneus in radiological imaging with anamnesis, clinical and physical examination
- Patients who signed the voluntary consent form
Key exclusion criteria (9 listed)
- Patients who have undergone interventional procedures for heel spurs in the last 6 months,
- Morbidly obese patients (BMI>35 kg/m2),
- Patients with advanced decompensated heart failure and pacemakers,
- Patients with known transcutaneous pad allergy, patients with skin infection in the area where ESWT was performed or pads were attached,
- Patients with metal implants,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous pulsed radiofrequencyInstead of invasive application of PRF directly to the lesion area or nerve, transcutaneous pulsed radiofrequency (TCPRF) is applied noninvasively. | Other | Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei) |
| extracorporeal shock wave therapy (ESWT)'A shock wave is created together with sound and pressure waves. Changes at the cellular level with the shock wave include increased collagen production, increased blood flow in the applied area, acceleration of wound healing and cellular proliferation. | Other | extracorporeal shock wave therapy (ESWT) |
Primary outcome
foot function index
Time frame: four months
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 30 Sep 2025.
- Individual participant dataSharing planned: No
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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.
halil ibrahim altun, specialist principal investigator
Kanuni Sultan Süleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous pulsed radiofrequency and extracorporeal shock wave therapy (ESWT)' in people with Pain, Chronic, run by Halil Ibrahim Altun 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 9 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 30 Sep 2025. 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?
foot function index (time frame: four months). 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 30 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.