University of Health Sciences Türkiye, Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Turkey (Türkiye)
NCT Number: NCT07537907
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 NRS score compared to baseline.
Time frame: Baseline to 3 months
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.
Time frame: 1 month and 3 months
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.
Time frame: 1 month and 3 months
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.
Time frame: Baseline, 1 month, and 3 months
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.
Şahide Eda Artuç
Other
Ultrasound-Guided Radiofrequency Ablation of the Inferior Calcaneal Nerve for Chronic Refractory Heel Pain: A Prospective Pilot Study
Acronym: ICN-RF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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