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

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.

Study Overview

• Status: Completed
• Conditions: Lower Extremity Amputation; Residual Limb Pain; Stump Neuroma
• Intervention / Treatment: Procedure: Radiofrequency ablation alone; Drug: Corticosteroid Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06800
      • Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants aged 18 to 65 years.
• Unilateral or bilateral traumatic lower extremity amputation.
• Amputation level: transfemoral, transtibial, or Syme amputation.
• Residual limb pain with a VAS score ≥ 4.
• Willing and able to provide informed consent.
• No injection to the distal stump and no surgery targeting the stump within the past 3 months.

Exclusion Criteria:

• Unwilling or unable to provide informed consent.
• Conditions in which radiofrequency ablation and/or steroid injection are contraindicated, including inflamed or infected skin, impaired skin integrity at the procedure site, active bleeding at the site, unstable epilepsy or unexplained seizure history, uncontrolled diabetes mellitus, unstable acute cardiac arrhythmia or heart failure, or presence of a cardiac pacemaker.
• History of allergy to the injected medications (e.g., local anesthetics and/or corticosteroids).
• Psychiatric disorder or cognitive impairment that would prevent completion of study questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-Guided Radiofrequency Ablation; Participants received ultrasound-guided radiofrequency ablation targeting the symptomatic stump neuroma.	Procedure: Radiofrequency ablation alone; Ultrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy.
Experimental: Ultrasound-Guided Corticosteroid Injection; Participants received ultrasound-guided corticosteroid injection for treatment of symptomatic stump neuroma.	Drug: Corticosteroid Injection; Ultrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months	Pain intensity at rest measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.	Baseline, 1 Month, and 3 Months
Change in Visual Analog Scale (VAS) Pain Score During Activity From Baseline to 3 Months	Pain intensity during activity measured using a 10-point Visual Analog Scale (0-10), with higher scores indicating greater pain.	Baseline, 1 Month, and 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score	Neuropathic pain characteristics assessed using the validated LANSS questionnaire at baseline, 1 month, and 3 months.	Baseline, 1 Month, and 3 Months
Change in Locomotor Capabilities Index (LCI) Score	Neuroma size assessed by ultrasound imaging at baseline, 1 month, and 3 months.	Baseline, 1 Month, and 3 Months
Change in Neuroma Long-Axis and Short-Axis Diameter Measured by Ultrasound	Baseline and 3 Months	Neuroma dimensions (long-axis and short-axis diameters) measured by ultrasound imaging at baseline and 3 months.
Change in Daily Prosthetic Wearing Time	Baseline and 3 Months	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.
Change in Sleep Quality Category	Sleep quality categorized based on participant self-report (e.g., very poor, poor, moderate, good, very good) assessed at baseline and 3 months.	Baseline and 3 Months

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2023
• Primary Completion (Actual): February 4, 2024
• Study Completion (Actual): February 4, 2024

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radiofrequency ablation; corticosteroid injection; lower extremity amputation; ultrasound-guided injection; residual limb pain; stump neuroma; neuroma size
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Adrenal Cortex Hormones; Radiofrequency Ablation
• Other Study ID Numbers: E2-23-3126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to institutional policies and data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No