Stump Neuroma, Residual Limb Pain, Lower Extremity Amputation
Conditions
Keywords
stump neuroma, residual limb pain, lower extremity amputation, radiofrequency ablation, ultrasound-guided injection, corticosteroid injection, neuroma size
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.
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.
Interventions
PROCEDURERadiofrequency ablation alone
Ultrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy.
DRUGCorticosteroid Injection
Ultrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief.
Sponsors
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The study was conducted as an open-label trial. However, statistical analysis was performed by an investigator who was blinded to treatment allocation.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain Score During Activity From Baseline to 3 Months | 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. |
| Change in Visual Analog Scale (VAS) Pain Score at Rest From Baseline to 3 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline and 3 Months |
| Change in Sleep Quality Category | 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. |
| Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score | Baseline, 1 Month, and 3 Months | Neuropathic pain characteristics assessed using the validated LANSS questionnaire at baseline, 1 month, and 3 months. |
| Change in Locomotor Capabilities Index (LCI) Score | Baseline, 1 Month, and 3 Months | Neuroma size assessed by ultrasound imaging at baseline, 1 month, 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. | Baseline and 3 Months |
Countries
Turkey (Türkiye)
Outcome results
None listed