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Completed

NCT Number: NCT07431424

Ultrasound-Guided Radiofrequency Ablation Versus Steroid Injection for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation alone

Procedure

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

Corticosteroid injection

Drug

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

Primary outcomes

  1. Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months

    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.

  2. Change in Visual Analog Scale (VAS) Pain Score During Activity From Baseline to 3 Months

    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.

Secondary outcomes

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

    Time frame: Baseline, 1 Month, and 3 Months

    Neuropathic pain characteristics assessed using the validated LANSS questionnaire at baseline, 1 month, and 3 months.

  2. Change in Locomotor Capabilities Index (LCI) Score

    Time frame: Baseline, 1 Month, and 3 Months

    Neuroma size assessed by ultrasound imaging at baseline, 1 month, and 3 months.

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

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

    Baseline and 3 Months

  4. Change in Daily Prosthetic Wearing Time

    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

  5. Change in Sleep Quality Category

    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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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