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Active Not RecruitingNCT07537907

Inferior Calcaneal Nerve Radiofrequency Ablation for Chronic Heel Pain

Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal Nerve for Chronic Refractory Heel Pain: A Prospective Pilot Study

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
31 (estimated)
Sponsor
Şahide Eda Artuç · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound-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.

Timeline

Start date
2025-03-31
Primary completion
2026-03-31
Completion
2026-06-30
First posted
2026-04-17
Last updated
2026-04-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07537907. Inclusion in this directory is not an endorsement.