Plantar Fasciitis, ChronicICN-RFNCT07537907
Inferior Calcaneal Nerve Radiofrequency Ablation for Chronic Heel Pain
A study testing Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve in people with Plantar Fasciitis, Chronic and Calcaneal Spur, run by Şahide Eda Artuç at 1 site in Turkey (Türkiye).
Trial summary
This prospective single-arm pilot interventional study aims to evaluate the effectiveness of ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve in patients with chronic heel pain refractory to conservative treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fasciitis, Chronic, Calcaneal Spur, Chronic Heel Pain
- What is being tested?
- Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2025to 30 Jun 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Chronic heel pain lasting longer than 6 months
- Clinical (tenderness and/or pain at the medial calcaneal tubercle) and radiological (X-ray or ultrasound) diagnosis of plantar fasciitis or calcaneal spur
- Refractory to at least four conservative treatment modalities, including exercise therapy, orthotic support (silicone heel pad), nonsteroidal anti-inflammatory drugs, extracorporeal shockwave therapy, and/or corticosteroid injection
Who cannot join
- History of trauma to the foot or ankle
- History of foot or ankle surgery
- Presence of systemic inflammatory disease
- Presence of peripheral neuropathy or S1 radiculopathy
- Pregnancy
- Hemodynamic instability
- Presence of skin or soft tissue infection at the injection site
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara
About this study
Official title: Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal Nerve for Chronic Refractory Heel Pain: A Prospective Pilot Study
This prospective single-arm pilot interventional study aims to evaluate the effectiveness of ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve in patients with chronic heel pain refractory to conservative treatments. Patients with plantar fasciitis or calcaneal spur who have not responded to multiple treatment modalities, including exercise, nonsteroidal anti-inflammatory drugs, orthotics, extracorporeal shockwave therapy, and corticosteroid injections, will be included. The procedure will be performed under ultrasound guidance. Pain intensity, functional status, and patient satisfaction will be assessed at baseline and at 1 and 3 months after the intervention.The primary outcome is treatment success, defined as a ≥50% reduction in morning pain intensity on the Numeric Rating Scale at 1 month compared to baseline.
Read the detailed description
Chronic heel pain, most commonly caused by plantar fasciitis or calcaneal spur, is a prevalent musculoskeletal condition that can significantly impair daily activities and quality of life. Although most patients respond to conservative treatments, a subset remains symptomatic despite multiple therapeutic interventions. In recent years, interventional procedures targeting peripheral nerve structures have gained increasing attention in the management of chronic musculoskeletal pain.
The inferior calcaneal nerve, a branch of the lateral plantar nerve, provides sensory innervation to the heel region and has been implicated in the pathophysiology of chronic heel pain. Targeting this nerve may offer a focused and potentially effective treatment option in refractory cases.
This study is designed as a prospective, single-arm pilot interventional study conducted at a tertiary rehabilitation center. Adult patients aged 18-75 years with chronic heel pain lasting more than 6 months and refractory to at least four conservative treatment modalities will be consecutively recruited. The intervention consists of ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve.
Clinical outcomes will be evaluated using the Numeric Rating Scale (NRS) for pain, Foot Function Index (FFI), Roles and Maudsley score, and a 5-point Likert patient satisfaction scale at baseline and during follow-up at 1 and 3 months. Treatment success will be defined as a ≥50% reduction in pain intensity at 1 month, while a ≥80% reduction will be considered marked improvement. In addition, the sustainability of treatment effects will be assessed at 3 months. Procedure-related adverse events will also be recorded.
The findings of this study are expected to provide preliminary evidence regarding the effectiveness and safety of inferior calcaneal nerve radiofrequency ablation in patients with chronic refractory heel pain and may inform the design of future larger-scale studies.
- Being tested
- Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve
- Keywords
- Inferior calcaneal nerve, radiofrequency ablation, heel pain, plantar fasciitis, Baxter nerve, ultrasound-guided intervention
- Medical subject headings
- Fasciitis, Plantar, Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) NerveProcedure or surgery
Ultrasound-guided radiofrequency ablation of the inferior calcaneal (Baxter) nerve is performed under sterile conditions. The target nerve is identified using a high-frequency linear ultrasound transducer. A radiofrequency needle is advanced to the vicinity of the nerve, and thermal lesioning is applied according to standard protocols to achieve pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation of the Inferior Calcaneal Nerve | Experimental | Participants with chronic heel pain associated with plantar fasciitis receive ultrasound-guided radiofrequency ablation of the inferior calcaneal (Baxter) nerve. Receives: Procedure: Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (Numeric Rating Scale, NRS)
Pain intensity is assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. Treatment success is defined as a ≥50% reduction in morning NRS score compared to baseline.
Measured: Baseline to 1 months
Secondary outcomes (4)
Change in Pain Intensity (Numeric Rating Scale, NRS)
Pain intensity is assessed using the 11-point Numeric Rating Scale (NRS). Changes in pain intensity over time will be evaluated to assess the sustainability of treatment effects.
Measured: Baseline to 3 months
Treatment Success Rate (≥50% Reduction in NRS)
Treatment success is defined as a reduction of at least 50% in NRS score compared to baseline. The proportion of patients achieving treatment success will be calculated at each follow-up time point.
Measured: 1 month and 3 months
Marked Improvement Rate (≥80% Reduction in NRS)
Marked improvement is defined as a reduction of at least 80% in NRS score compared to baseline. The proportion of patients achieving marked improvement will be calculated at each follow-up time point.
Measured: 1 month and 3 months
Foot Function Index (FFI)
Functional status is assessed using the Foot Function Index (FFI), a validated questionnaire evaluating pain, disability, and activity limitation related to foot disorders. Scores range from 0 to 100, with higher scores indicating worse pain and functional impairment.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start31 Mar 2025
- Primary completion31 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis, 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm interventional study in which all participants receive ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve. Clinical outcomes are assessed at baseline and during follow-up visits.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şahide Eda Artuç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şahide Eda Artuç, Saglik Bilimleri Universitesi
- Investigators
- Şahide Eda Artuç, MD, Principal investigator, University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537907
- Sponsor's protocol ID
- ICN-RF-2025-01
- Acronym
- ICN-RF
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal Nerve for Chronic Refractory Heel Pain: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07537907
- Acronym / sponsor ID
- ICN-RF / ICN-RF-2025-01
- Keywords
- Inferior calcaneal nerve, radiofrequency ablation, heel pain, plantar fasciitis, Baxter nerve, ultrasound-guided intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Şahide Eda ArtuçUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Apr 2026 (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.
This prospective single-arm pilot interventional study aims to evaluate the effectiveness of ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve in patients with chronic heel pain refractory to conservative treatments. Patients with plantar fasciitis or calcaneal spur who have not responded to multiple treatment modalities, including exercise, nonsteroidal anti-inflammatory drugs, orthotics, extracorporeal shockwave therapy, and corticosteroid injections, will be included. The procedure will be performed under ultrasound guidance. Pain intensity, functional status, and patient satisfaction will be assessed at baseline and at 1 and 3 months after the intervention.The primary outcome is treatment success, defined as a ≥50% reduction in morning pain intensity on the Numeric Rating Scale at 1 month compared to baseline.
Detailed description
Chronic heel pain, most commonly caused by plantar fasciitis or calcaneal spur, is a prevalent musculoskeletal condition that can significantly impair daily activities and quality of life. Although most patients respond to conservative treatments, a subset remains symptomatic despite multiple therapeutic interventions. In recent years, interventional procedures targeting peripheral nerve structures have gained increasing attention in the management of chronic musculoskeletal pain.
The inferior calcaneal nerve, a branch of the lateral plantar nerve, provides sensory innervation to the heel region and has been implicated in the pathophysiology of chronic heel pain. Targeting this nerve may offer a focused and potentially effective treatment option in refractory cases.
This study is designed as a prospective, single-arm pilot interventional study conducted at a tertiary rehabilitation center. Adult patients aged 18-75 years with chronic heel pain lasting more than 6 months and refractory to at least four conservative treatment modalities will be consecutively recruited. The intervention consists of ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve.
Clinical outcomes will be evaluated using the Numeric Rating Scale (NRS) for pain, Foot Function Index (FFI), Roles and Maudsley score, and a 5-point Likert patient satisfaction scale at baseline and during follow-up at 1 and 3 months. Treatment success will be defined as a ≥50% reduction in pain intensity at 1 month, while a ≥80% reduction will be considered marked improvement. In addition, the sustainability of treatment effects will be assessed at 3 months. Procedure-related adverse events will also be recorded.
The findings of this study are expected to provide preliminary evidence regarding the effectiveness and safety of inferior calcaneal nerve radiofrequency ablation in patients with chronic refractory heel pain and may inform the design of future larger-scale studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm interventional study in which all participants receive ultrasound-guided radiofrequency ablation of the inferior calcaneal nerve. Clinical outcomes are assessed at baseline and during follow-up visits.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation of the Inferior Calcaneal Nerve | Experimental | Procedure: Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) NerveParticipants with chronic heel pain associated with plantar fasciitis receive ultrasound-guided radiofrequency ablation of the inferior calcaneal (Baxter) nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- Chronic heel pain lasting longer than 6 months
- Clinical (tenderness and/or pain at the medial calcaneal tubercle) and radiological (X-ray or ultrasound) diagnosis of plantar fasciitis or calcaneal spur
- Refractory to at least four conservative treatment modalities, including exercise therapy, orthotic support (silicone heel pad), nonsteroidal anti-inflammatory drugs, extracorporeal shockwave therapy, and/or corticosteroid injection
Key exclusion criteria (8 listed)
- History of trauma to the foot or ankle
- History of foot or ankle surgery
- Presence of systemic inflammatory disease
- Presence of peripheral neuropathy or S1 radiculopathy
- Pregnancy
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 |
|---|---|---|
| Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) NerveUltrasound-guided radiofrequency ablation of the inferior calcaneal (Baxter) nerve is performed under sterile conditions. The target nerve is identified using a high-frequency linear ultrasound transducer. A radiofrequency needle is advanced to the vicinity of the nerve, and thermal lesioning is applied according to standard protocols to achieve pain relief. | Procedure or surgery | Radiofrequency Ablation of the Inferior Calcaneal Nerve |
Primary outcome
Change in Pain Intensity (Numeric Rating Scale, NRS)
Time frame: Baseline to 1 months
Pain intensity is assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. Treatment success is defined as a ≥50% reduction in morning NRS score compared to baseline.
4 secondary outcomes
Change in Pain Intensity (Numeric Rating Scale, NRS)
Time frame: Baseline to 3 months
Treatment Success Rate (≥50% Reduction in NRS)
Time frame: 1 month and 3 months
Marked Improvement Rate (≥80% Reduction in NRS)
Time frame: 1 month and 3 months
Foot Function Index (FFI)
Time frame: Baseline, 1 month, and 3 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 9 Sep 2026.
- 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.
Şahide Eda Artuç, MD principal investigator
University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation 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 Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve in people with Plantar Fasciitis, Chronic and Calcaneal Spur, run by Şahide Eda Artuç 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 4 inclusion and 8 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 9 Sep 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?
Change in Pain Intensity (Numeric Rating Scale, NRS) (time frame: Baseline to 1 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 9 Sep 2026.