Ultrasound-Guided Radiofrequency Ablation Versus Steroid Injection for Stump Neuroma

NCT07431424 | Completed

• 1 other identifier: E2-23-3126
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stump Neuroma; Residual Limb Pain; Lower Extremity Amputation

Keywords

stump neuroma; residual limb pain; lower extremity amputation; radiofrequency ablation; ultrasound-guided injection; corticosteroid injection; neuroma size

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score

  Baseline, 1 Month, and 3 Months

• Change in Locomotor Capabilities Index (LCI) Score

  Baseline, 1 Month, and 3 Months

• Change in Neuroma Long-Axis and Short-Axis Diameter Measured by Ultrasound

  Neuroma dimensions (long-axis and short-axis diameters) measured by ultrasound imaging at baseline and 3 months.

• Change in Daily Prosthetic Wearing Time

  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

  Baseline and 3 Months

Study Arms (2)

Ultrasound-Guided Radiofrequency Ablation

EXPERIMENTAL

Participants received ultrasound-guided radiofrequency ablation targeting the symptomatic stump neuroma.

Procedure: Radiofrequency ablation alone

Ultrasound-Guided Corticosteroid Injection

EXPERIMENTAL

Participants received ultrasound-guided corticosteroid injection for treatment of symptomatic stump neuroma.

Drug: Corticosteroid Injection

Interventions

Radiofrequency ablation alone PROCEDURE

Ultrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy.

Ultrasound-Guided Radiofrequency Ablation

Corticosteroid Injection DRUG

Ultrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief.

Ultrasound-Guided Corticosteroid Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Radiofrequency Ablation; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The study was conducted as an open-label trial. However, statistical analysis was performed by an investigator who was blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Model Details: Participants were assigned to one of two parallel treatment groups: ultrasound-guided radiofrequency ablation or ultrasound-guided corticosteroid injection. Each participant received a single interventional treatment and was followed prospectively for outcome assessment.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: January 8, 2023
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)