CompletedNot Applicable

Ultrasound-Guided Radiofrequency Ablation Versus Steroid Injection for Stump Neuroma

Turkey (Türkiye)26 participantsStarted 2023-01-08

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline, 1 Month, and 3 Months

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

Timeframe: Baseline, 1 Month, and 3 Months

Trial details

NCT IDNCT07431424

SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-04