Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, 06800, Turkey (Türkiye)
NCT Number: NCT07431424
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.
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Notify Me18 year–65 year
Male
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy.
Ultrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief.
Time frame: Baseline, 1 Month, and 3 Months
Pain intensity at rest measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.
Time frame: Baseline, 1 Month, and 3 Months
Pain intensity during activity measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.
Time frame: Baseline, 1 Month, and 3 Months
Neuropathic pain characteristics assessed using the validated LANSS questionnaire at baseline, 1 month, and 3 months.
Time frame: Baseline, 1 Month, and 3 Months
Neuroma size assessed by ultrasound imaging at baseline, 1 month, and 3 months.
Time frame: Neuroma dimensions (long-axis and short-axis diameters) measured by ultrasound imaging at baseline and 3 months.
Baseline and 3 Months
Time frame: Daily duration of prosthetic use reported in hours per day, assessed at baseline and 3 months. Measured as the average number of hours per day the prosthesis was worn.
Baseline and 3 Months
Time frame: Baseline and 3 Months
Sleep quality categorized based on participant self-report (e.g., very poor, poor, moderate, good, very good) assessed at baseline and 3 months.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Other
A Prospective Comparative Study of Ultrasound-Guided Radiofrequency Ablation and Steroid Injection in Individuals With Lower Extremity Amputation and Symptomatic Stump Neuroma
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