Inferior Calcaneal Nerve Radiofrequency Ablation for Chronic Heel Pain

NCT07537907 | Active Not Recruiting

• 1 other identifier: ICN-RF-2025-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Plantar Fasciitis, Chronic; Calcaneal Spur; Chronic Heel Pain

Keywords

Inferior calcaneal nerve; radiofrequency ablation; heel pain; plantar fasciitis; Baxter nerve; ultrasound-guided intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Pain Intensity (Numeric Rating Scale, NRS)

  Baseline to 3 months

• Treatment Success Rate (≥50% Reduction in NRS)

  1 month and 3 months

• Marked Improvement Rate (≥80% Reduction in NRS)

  1 month and 3 months

• Foot Function Index (FFI)

  Baseline, 1 month, and 3 months

Study Arms (1)

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.

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

Interventions

Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal (Baxter) Nerve PROCEDURE

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.

Radiofrequency Ablation of the Inferior Calcaneal Nerve

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Şahide Eda Artuç: lead

Study Sites (1)

University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Heel Spur

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Exostoses; Hyperostosis; Bone Diseases

Study Officials

• Şahide Eda Artuç, MD

  University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiatrist (Specialist in Physical Medicine and Rehabilitation)

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: March 31, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)