Inferior Calcaneal Nerve Radiofrequency Ablation for Chronic Heel Pain (ICN-RF)

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 pain intensity at 1 month compared to baseline.

Study Overview

• Status: Active, not recruiting
• Conditions: Plantar Fasciitis, Chronic; Calcaneal Spur; Chronic Heel Pain
• Intervention / Treatment: Procedure: Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve

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 Type: Interventional
• Enrollment (Estimated): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiofrequency Ablation of the Inferior Calcaneal Nerve; Participants with chronic heel pain associated with plantar fasciitis receive ultrasound-guided radiofrequency ablation of the inferior calcaneal (Baxter) nerve.

Procedure: Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 NRS score compared to baseline.	Baseline to 1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 1 month, and 3 months

Collaborators and Investigators

• Sponsor: Şahide Eda Artuç
• Investigators: Principal Investigator: Şahide Eda Artuç, MD, University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; plantar fasciitis; ultrasound-guided intervention; heel pain; Inferior calcaneal nerve; Baxter nerve
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Foot Diseases; Exostoses; Hyperostosis; Fasciitis; Fasciitis, Plantar; Heel Spur
• Other Study ID Numbers: ICN-RF-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No