A Prospective Comparative Study of Ultrasound-Guided Radiofrequency Ablation and Steroid Injection in Individuals With Lower Extremity Amputation and Symptomatic Stump Neuroma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study was conducted as an open-label trial. However, statistical analysis was performed by an investigator who was blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Willing and able to provide informed consent.
- •No injection to the distal stump and no surgery targeting the stump within the past 3 months.
排除标准
- •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.
研究组 & 干预措施
Ultrasound-Guided Radiofrequency Ablation
Participants received ultrasound-guided radiofrequency ablation targeting the symptomatic stump neuroma.
干预措施: Radiofrequency ablation alone (Procedure)
Ultrasound-Guided Corticosteroid Injection
Participants received ultrasound-guided corticosteroid injection for treatment of symptomatic stump neuroma.
干预措施: Corticosteroid Injection (Drug)
结局指标
主要结局
Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months
时间窗: 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.
Change in Visual Analog Scale (VAS) Pain Score During Activity From Baseline to 3 Months
时间窗: 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.
次要结局
- 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)
研究者
Yasin Demir
Professor of Physical Medicine and Rehabilitation
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital