Clinical Trials Directory

Trials / Completed

CompletedNCT07431424

Ultrasound-Guided Radiofrequency Ablation Versus Steroid Injection for Stump Neuroma

A Prospective Comparative Study of Ultrasound-Guided Radiofrequency Ablation and Steroid Injection in Individuals With Lower Extremity Amputation and Symptomatic Stump Neuroma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Academic / Other
Sex
Male
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This prospective clinical study aims to compare the effectiveness of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. Stump neuroma is a common cause of residual limb pain and may significantly impair mobility and quality of life. Participants undergoing either treatment will be evaluated prospectively. Pain intensity, neuropathic pain characteristics, functional mobility, socket comfort, sleep quality, and neuroma size measured by ultrasound will be assessed during follow-up. The study seeks to provide clinical evidence regarding the comparative clinical and radiological outcomes of these two treatment approaches.

Detailed description

Lower extremity amputation is frequently associated with persistent residual limb pain. One of the most common causes of residual limb pain is symptomatic stump neuroma, which may lead to functional limitation, reduced prosthetic tolerance, and decreased quality of life. Neuroma-related pain is often described as burning, stabbing, or electric shock-like in nature and may be triggered by mechanical stimulation. Diagnosis is based on clinical evaluation and imaging methods, particularly ultrasound, which allows visualization of the neuroma as a hypoechoic mass contiguous with the affected peripheral nerve. Various treatment options have been described for symptomatic neuroma, including pharmacological therapy, physical modalities, steroid injections, ablative procedures, and surgical intervention. Although surgical treatment is considered effective, it may be associated with recurrence, scar formation, and delayed prosthetic rehabilitation. Minimally invasive interventions such as ultrasound-guided corticosteroid injection and radiofrequency ablation have gained increasing attention as alternative treatment options. Corticosteroid injection is thought to reduce pain through anti-inflammatory effects and stabilization of neural membranes. Radiofrequency ablation uses controlled thermal energy to create targeted nerve lesioning, thereby reducing nociceptive signal transmission. This prospective clinical study compares the clinical and ultrasonographic outcomes of ultrasound-guided radiofrequency ablation and ultrasound-guided corticosteroid injection in individuals with symptomatic stump neuroma following lower extremity amputation. The primary aim is to evaluate and compare pain reduction, functional improvement, and changes in neuroma size following these two interventional approaches.

Conditions

Interventions

TypeNameDescription
PROCEDURERadiofrequency ablation aloneUltrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy.
DRUGCorticosteroid InjectionUltrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief.

Timeline

Start date
2023-01-08
Primary completion
2024-02-04
Completion
2024-02-04
First posted
2026-02-24
Last updated
2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07431424. Inclusion in this directory is not an endorsement.