Plantar FasciopathyNCT07120204
One Cause of Heel Pain is Plantar Fasciopathy (PF). In Most Cases, a Heel Spur is Frequently Present Alongside PF. We Aim to Evaluate the Efficacy of Corticosteroid Injection and Radiofrequency Ablation, Along With Tissue Elasticity Assessed by Ultrasound, in Patients With Chronic Pain (≥6 Months).
A study testing Corticosteroid Injection and Radiofrequency thermocoagulation in people with Plantar Fasciopathy and Chronic Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Heel pain is common among adults. One cause of heel pain is plantar fasciopathy (PF). In most cases, a heel spur, a bony prominence that extends into the plantar fascia, is frequently present alongside PF. First-line treatments include pain-relieving drugs, home exercises, heel support peds, and physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plantar Fasciopathy, Chronic Pain, Corticosteroid Injection
- What is being tested?
- Corticosteroid Injection and Radiofrequency thermocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic (≥ 6 months) plantar fasciopathy
- NRS score ≥ 4
- Presence of a calcaneal spur detected by ultrasound (USG) or direct radiography
- At least one of the following treatments has been administered:
- Home exercise program
- Physiotherapy
Show all 12Show fewer
- Orthosis/prosthesis
- NSAIDs
- Night splint
- Kinesio taping
- Corticosteroid injection
- Extracorporeal shock wave therapy (ESWT)
Who cannot join
- History of calcaneal trauma/fracture
- Previous radiofrequency ablation (RFA) treatment
- Patients with seronegative spondyloarthropathy
- Inflammatory or degenerative arthropathies
- Presence of diabetes
- Pregnancy
Show all 15Show fewer
- History of cancer
- Peripheral neuropathy or ischemia
- Open wound or signs of infection at the procedure site
- Evidence of systemic infection
- Patients using anticoagulant or antiplatelet agents
- Presence of an intracardiac defibrillator or pacemaker
- Patients with tarsal tunnel syndrome
- Patients who have received ESWT and/or corticosteroid injection within the last 3 months
- Presence of heel pain due to lumbar radiculopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erciyes Üniversitesi Tıp Fakültesi
Kayseri, Talas
Gülen Güler, Prof. Dr., M.D., +905327922484, gulen@erciyes.edu.tr
Gülen Güler, Prof. Dr. M.D.
About this study
Official title: Evaluation of Radiofrequency Thermocoagulation Versus Corticosteroid Injection in Patients With Chronic Calcaneal Spur Related Plantar Fasciopathy Using Elastography and Foot Function Index
Heel pain is common among adults. One cause of heel pain is plantar fasciopathy (PF). In most cases, a heel spur, a bony prominence that extends into the plantar fascia, is frequently present alongside PF. First-line treatments include pain-relieving drugs, home exercises, heel support peds, and physical therapy. However, some patients can't get relief from these therapies, and the pain persists beyond six months. This situation is referred to as refractory chronic PF. Local treatments applied via skin puncture such as anti-inflamtory injection and destruction of nerves carrying pain signals to brain are warranted in these cases. We aim to evaluate the efficacy of corticosteroid injection and radiofrequency ablation, along with tissue elasticity assessed by ultrasound, in patients with chronic pain (≥6 months).
The goal of this clinical trial is to determine which treatment-corticosteroid injection or radiofrequency thermal thermocoagulation-is more effective for treating plantar fasciopathy in adults. It will also learn about the effects of the treatments on the properties of the heel tissue using ultrasound. The main questions it aims to answer are:
Do corticosteroid injections and radiofrequency thermal thermocoagulation have the same efficacy on pain and functionality for both short- and long-term? Do corticosteroid injections and radiofrequency thermal thermocoagulation similarly affect heel tissue? The researchers will investigate which of the corticosteroid injection and radiofrequency thermocoagulation is more effective for
Read the detailed description
Plantar fasciopathy (PF) is one of the most common causes of foot pain, accounting for approximately 10-15% of all cases. The plantar fascia originates from the calcaneus on the plantar surface of the foot and inserts into the proximal phalanges. It becomes tense while standing and provides support to the medial longitudinal arch. Although the pathophysiology of PF is not fully understood, repetitive mechanical overload is believed to cause microtears, particularly at the medial origin of the plantar fascia. Subsequent inflammation and degeneration may become chronic, and excessive traction at the medial calcaneus can lead to the formation of a bony outgrowth called a calcaneal spur. This bony protrusion may increase pain by causing inflammation, nerve compression, and atrophy of the heel fat pad. Approximately 67% of patients with PF present with a calcaneal spur.
Typically, patients complain of heel pain upon taking their first steps in the morning or after periods of rest, and during weight-bearing activities. On physical examination, tenderness is usually observed along the medial aspect of the heel, and pain is exacerbated with toe extension. Diagnosis is generally based on clinical history and physical examination. Ultrasound imaging can aid in diagnosis due to its rapid application and bedside availability. Conventional ultrasonography may reveal thickening of the plantar fascia, perifascial edema, hypoechoic areas within the fascia, and the presence of a calcaneal spur.
Shear wave elastography (SWE) is a modern, non-invasive ultrasound modality that measures tissue stiffness and elasticity. Measuring the stiffness of the plantar fascia using SWE, along with B-mode parameters, can facilitate diagnosis. Moreover, it allows monitoring of structural changes in the fascia following treatment.
Treatment options for PF include non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, orthotics, night splints, corticosteroid injections (CSIs), platelet-rich plasma injections, extracorporeal shockwave therapy, and radiofrequency ablation (RFA). While corticosteroid injection may provide short-term pain relief, it is associated with risks, including alteration of connective tissue microstructure and fat pad atrophy. In RFA, continuous electrical current generates heat, leading to the destruction of nociceptive free nerve endings in the target area. RFA has been successfully used for decades in the management of lower back pain, head and facial pain, sympathetic chain ablation, and joint pain. Various studies have also supported its efficacy and safety in treating PF.
The primary aim of this study is to compare the effectiveness of RFA and CSI using the Foot Function Index (FFI) score at 6 months. The secondary aim is to assess pain scores and structural changes in the plantar fascia using SWE.
- Conditions
- Plantar Fasciopathy, Chronic Pain, Corticosteroid Injection, Radiofrequency Ablation, Elasticity Imaging Techniques
- Being tested
- Corticosteroid Injection, Radiofrequency thermocoagulation
- Keywords
- plantar fasciopathy, plantar fasciitis, randomized, radiofrequency thermal coagulation, RF, shear wave, elastography
- Medical subject headings
- Chronic Pain, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid InjectionDrug
The symptomatic foot will be prepared with povidone-iodine and draped in a sterile manner. A sterile-covered ultrasound probe will be placed over the heel to visualize the calcaneus, plantar fascia, and any calcaneal spur. Subsequently, 1 mL of triamcinolone acetonide 40 mg (KENACORT-A IM/Intra-articular Retard 40 mg ampoule) and 1 mL of 2% lidocaine (Aritmal 2% ampoule) will be injected over the plantar fascia.
Radiofrequency thermocoagulationProcedure or surgery
The patient will be in the lateral decubitus position with the symptomatic foot below. The foot was prepared with povidone-iodine and draped under sterile conditions. A sterilized ultrasound probe was placed over the heel to visualize the calcaneus, plantar fascia, and calcaneal spur. A 10 cm long radiofrequency (RF) needle with a 5 mm active tip was advanced in-plane under ultrasound guidance toward the tip of the calcaneal spur. Sensory stimulation at 50 Hz elicited paresthesia in the medial calcaneus, while motor stimulation at 2 Hz did not produce any muscle contractions. The RF generator (Beijing Neo Science Co., RFE 4b) was set to 80 °C for 90 seconds, and the RFA procedure was initiated.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Injection | Active comparator | The patient will be in the lateral decubitus position with the symptomatic foot below. The symptomatic foot will be prepared with povidone-iodine and draped in a sterile manner. A sterile-covered ultrasound probe will be placed over the heel to visualize the calcaneus, plantar fascia, and any calcaneal spur. Subsequently, 1 mL of triamcinolone acetonide 40 mg (KENACORT-A IM/Intra-articular Retard 40 mg ampoule) and 1 mL of 2% lidocaine (Aritmal 2% ampoule) will be injected over the plantar fascia. Receives: Drug: Corticosteroid Injection |
| Radiofrequency Thermocoagulation | Active comparator | The patient will be in the lateral decubitus position with the symptomatic foot below. The foot was prepared with povidone-iodine and draped under sterile conditions. A sterilized ultrasound probe was placed over the heel to visualize the calcaneus, plantar fascia, and calcaneal spur. A 10 cm long radiofrequency (RF) needle with a 5 mm active tip was advanced in-plane under ultrasound guidance toward the tip of the calcaneal spur. Sensory stimulation at 50 Hz elicited paresthesia in the medial calcaneus, while motor stimulation at 2 Hz did not produce any muscle contractions. The RF generator (Beijing Neo Science Co., RFE 4b) was set to 80 °C for 90 seconds, and the RFA procedure was initiated. Receives: Procedure: Radiofrequency thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index Score (FFI)
FFI includes 23 11-point Likert-type questions about feet. The lowest score is 0, and the highest score is 100. A lower score is better.
Measured: 6 months after treatment
Secondary outcomes (1)
Numeric Rating Scale-11 (NRS-11) Scores
NRS-11 is an 11-point Likert-type scale that assesses pain severity. The lowest score is 0, and the highest score is 10. A lower score is better
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciopathyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized, Open-Label Study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülen Güler, TC Erciyes University
- Investigators
- Gülen Güler, Prof. Dr., M.D., Study director, Erciyes Üniversity School of Medicine, Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120204
- Sponsor's protocol ID
- 2025/60
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deindividualized data will be shared upon reasonable request.
Publications
Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
PubMed 18524985
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiofrequency Thermocoagulation Versus Corticosteroid Injection in Patients With Chronic Calcaneal Spur Related Plantar Fasciopathy Using Elastography and Foot Function Index
- ClinicalTrials.gov ID
- NCT07120204
- Acronym / sponsor ID
- 2025/60
- Conditions
- Plantar Fasciopathy, Chronic Pain, Corticosteroid Injection, Radiofrequency Ablation, Elasticity Imaging Techniques
- Keywords
- plantar fasciopathy, plantar fasciitis, randomized, radiofrequency thermal coagulation, RF, shear wave, elastography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 13 Aug 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 common among adults. One cause of heel pain is plantar fasciopathy (PF). In most cases, a heel spur, a bony prominence that extends into the plantar fascia, is frequently present alongside PF. First-line treatments include pain-relieving drugs, home exercises, heel support peds, and physical therapy. However, some patients can't get relief from these therapies, and the pain persists beyond six months. This situation is referred to as refractory chronic PF. Local treatments applied via skin puncture such as anti-inflamtory injection and destruction of nerves carrying pain signals to brain are warranted in these cases. We aim to evaluate the efficacy of corticosteroid injection and radiofrequency ablation, along with tissue elasticity assessed by ultrasound, in patients with chronic pain (≥6 months).
The goal of this clinical trial is to determine which treatment-corticosteroid injection or radiofrequency thermal thermocoagulation-is more effective for treating plantar fasciopathy in adults. It will also learn about the effects of the treatments on the properties of the heel tissue using ultrasound. The main questions it aims to answer are:
Do corticosteroid injections and radiofrequency thermal thermocoagulation have the same efficacy on pain and functionality for both short- and long-term? Do corticosteroid injections and radiofrequency thermal thermocoagulation similarly affect heel tissue? The researchers will investigate which of the corticosteroid injection and radiofrequency thermocoagulation is more effective for
Detailed description
Plantar fasciopathy (PF) is one of the most common causes of foot pain, accounting for approximately 10-15% of all cases. The plantar fascia originates from the calcaneus on the plantar surface of the foot and inserts into the proximal phalanges. It becomes tense while standing and provides support to the medial longitudinal arch. Although the pathophysiology of PF is not fully understood, repetitive mechanical overload is believed to cause microtears, particularly at the medial origin of the plantar fascia. Subsequent inflammation and degeneration may become chronic, and excessive traction at the medial calcaneus can lead to the formation of a bony outgrowth called a calcaneal spur. This bony protrusion may increase pain by causing inflammation, nerve compression, and atrophy of the heel fat pad. Approximately 67% of patients with PF present with a calcaneal spur.
Typically, patients complain of heel pain upon taking their first steps in the morning or after periods of rest, and during weight-bearing activities. On physical examination, tenderness is usually observed along the medial aspect of the heel, and pain is exacerbated with toe extension. Diagnosis is generally based on clinical history and physical examination. Ultrasound imaging can aid in diagnosis due to its rapid application and bedside availability. Conventional ultrasonography may reveal thickening of the plantar fascia, perifascial edema, hypoechoic areas within the fascia, and the presence of a calcaneal spur.
Shear wave elastography (SWE) is a modern, non-invasive ultrasound modality that measures tissue stiffness and elasticity. Measuring the stiffness of the plantar fascia using SWE, along with B-mode parameters, can facilitate diagnosis. Moreover, it allows monitoring of structural changes in the fascia following treatment.
Treatment options for PF include non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, orthotics, night splints, corticosteroid injections (CSIs), platelet-rich plasma injections, extracorporeal shockwave therapy, and radiofrequency ablation (RFA). While corticosteroid injection may provide short-term pain relief, it is associated with risks, including alteration of connective tissue microstructure and fat pad atrophy. In RFA, continuous electrical current generates heat, leading to the destruction of nociceptive free nerve endings in the target area. RFA has been successfully used for decades in the management of lower back pain, head and facial pain, sympathetic chain ablation, and joint pain. Various studies have also supported its efficacy and safety in treating PF.
The primary aim of this study is to compare the effectiveness of RFA and CSI using the Foot Function Index (FFI) score at 6 months. The secondary aim is to assess pain scores and structural changes in the plantar fascia using SWE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-Label Study
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injection | Active comparator | Drug: Corticosteroid InjectionThe patient will be in the lateral decubitus position with the symptomatic foot below. The symptomatic foot will be prepared with povidone-iodine and draped in a sterile manner. A sterile-covered ultrasound probe will be placed over the heel to visualize the calcaneus, plantar fascia, and any calcaneal spur. Subsequently, 1 mL of triamcinolone acetonide 40 mg (KENACORT-A IM/Intra-articular Retard 40 mg ampoule) and 1 mL of 2% lidocaine (Aritmal 2% ampoule) will be injected over the plantar fascia. |
| Radiofrequency Thermocoagulation | Active comparator | Procedure: Radiofrequency thermocoagulationThe patient will be in the lateral decubitus position with the symptomatic foot below. The foot was prepared with povidone-iodine and draped under sterile conditions. A sterilized ultrasound probe was placed over the heel to visualize the calcaneus, plantar fascia, and calcaneal spur. A 10 cm long radiofrequency (RF) needle with a 5 mm active tip was advanced in-plane under ultrasound guidance toward the tip of the calcaneal spur. Sensory stimulation at 50 Hz elicited paresthesia in the medial calcaneus, while motor stimulation at 2 Hz did not produce any muscle contractions. The RF generator (Beijing Neo Science Co., RFE 4b) was set to 80 °C for 90 seconds, and the RFA procedure was initiated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with chronic (≥ 6 months) plantar fasciopathy
- NRS score ≥ 4
- Presence of a calcaneal spur detected by ultrasound (USG) or direct radiography
- At least one of the following treatments has been administered:
Key exclusion criteria (15 listed)
- History of calcaneal trauma/fracture
- Previous radiofrequency ablation (RFA) treatment
- Patients with seronegative spondyloarthropathy
- Inflammatory or degenerative arthropathies
- Presence of diabetes
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 |
|---|---|---|
| Corticosteroid InjectionThe symptomatic foot will be prepared with povidone-iodine and draped in a sterile manner. A sterile-covered ultrasound probe will be placed over the heel to visualize the calcaneus, plantar fascia, and any calcaneal spur. Subsequently, 1 mL of triamcinolone acetonide 40 mg (KENACORT-A IM/Intra-articular Retard 40 mg ampoule) and 1 mL of 2% lidocaine (Aritmal 2% ampoule) will be injected over the plantar fascia. | Drug | Corticosteroid Injection |
| Radiofrequency thermocoagulationThe patient will be in the lateral decubitus position with the symptomatic foot below. The foot was prepared with povidone-iodine and draped under sterile conditions. A sterilized ultrasound probe was placed over the heel to visualize the calcaneus, plantar fascia, and calcaneal spur. A 10 cm long radiofrequency (RF) needle with a 5 mm active tip was advanced in-plane under ultrasound guidance toward the tip of the calcaneal spur. Sensory stimulation at 50 Hz elicited paresthesia in the medial calcaneus, while motor stimulation at 2 Hz did not produce any muscle contractions. The RF generator (Beijing Neo Science Co., RFE 4b) was set to 80 °C for 90 seconds, and the RFA procedure was initiated. | Procedure or surgery | Radiofrequency Thermocoagulation |
Primary outcome
Foot Function Index Score (FFI)
Time frame: 6 months after treatment
FFI includes 23 11-point Likert-type questions about feet. The lowest score is 0, and the highest score is 100. A lower score is better.
1 secondary outcome
Numeric Rating Scale-11 (NRS-11) Scores
Time frame: 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 18524985Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
- Individual participant dataSharing planned: Yes. Deindividualized data will be shared upon reasonable request.
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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.
Gülen Güler, Prof. Dr., M.D. study director
Erciyes Üniversity School of Medicine, Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid Injection and Radiofrequency thermocoagulation in people with Plantar Fasciopathy and Chronic Pain, run by TC Erciyes University 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 12 inclusion and 15 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: opening soon, as of the sponsor's last update on 13 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ersin Sönmez, M.D. (+905370257858, ersinsonmez@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Index Score (FFI) (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120204, which also lists 1 linked publication.
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 13 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.