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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-Guided Radiofrequency Ablation | Experimental | Participants received ultrasound-guided radiofrequency ablation targeting the symptomatic stump neuroma. |
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| Ultrasound-Guided Corticosteroid Injection | Experimental | Participants received ultrasound-guided corticosteroid injection for treatment of symptomatic stump neuroma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation alone | Procedure | Ultrasound-guided radiofrequency ablation was performed targeting the symptomatic stump neuroma using controlled thermal energy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score | Neuropathic pain characteristics assessed using the validated LANSS questionnaire at baseline, 1 month, and 3 months. | Baseline, 1 Month, and 3 Months |
| Change in Locomotor Capabilities Index (LCI) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziler Physical Medicine and Rehabilitation Training and Research Hospital | Ankara | Ankara | 06800 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to institutional policies and data protection regulations.
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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.
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The study was conducted as an open-label trial. However, statistical analysis was performed by an investigator who was blinded to treatment allocation.
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| Corticosteroid Injection | Drug | Ultrasound-guided corticosteroid injection was administered to the symptomatic stump neuroma for pain relief. |
|
Neuroma size assessed by ultrasound imaging at baseline, 1 month, and 3 months. |
| Baseline, 1 Month, and 3 Months |
| Change in Neuroma Long-Axis and Short-Axis Diameter Measured by Ultrasound | Baseline and 3 Months | Neuroma dimensions (long-axis and short-axis diameters) measured by ultrasound imaging at baseline and 3 months. |
| Change in Daily Prosthetic Wearing Time | Baseline and 3 Months | 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 | Sleep quality categorized based on participant self-report (e.g., very poor, poor, moderate, good, very good) assessed at baseline and 3 months. | Baseline and 3 Months |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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