RecruitingNot ApplicableNCT07416448

Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine

Comprehensive Multicenter Study on the Management of Neuroma-Associated Pain Following Combat-Related Trauma in Ukraine


Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Enrollment

50 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter interventional study in Ukraine is designed to compare the effectiveness of cryoablation and radiofrequency ablation in managing neuroma-associated pain following combat-related trauma. Adult patients with clinically significant neuropathic pain caused by neuromas will be randomly assigned to receive either image-guided cryoablation or radiofrequency ablation of the affected nerve. Cryoablation uses controlled cold temperatures to temporarily disrupt nerve conduction, while radiofrequency ablation uses thermal energy to modulate nerve function. Both interventions are minimally invasive and performed under image guidance. The study will evaluate changes in pain intensity, opioid consumption, functional outcomes, and patient-reported measures at predefined time points following the procedure. This research aims to provide evidence on which intervention is more effective in reducing pain, improving function, and minimizing the need for opioid medications in patients with combat-related neuroma pain.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at pain management for combat-related injuries in Ukraine, specifically targeting neuromas — painful growths that form on damaged nerves after traumatic injury. Researchers are testing minimally invasive treatments to relieve this type of chronic nerve pain. **You may be eligible if...** - You are 18 or older - You sustained a combat-related injury - You have significant nerve pain from a neuroma (score 4 or higher on a pain scale) - You are medically stable enough to undergo a procedure **You may NOT be eligible if...** - Your pain is mild or not confirmed to be from a neuroma - You have conditions that make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREcryoablation

Participants in this arm will receive image-guided cryoablation of the neuroma or affected peripheral nerve. The procedure involves percutaneous application of controlled low temperatures to temporarily interrupt nerve conduction while preserving overall nerve structure. The number of treated nerve levels is determined based on the location and extent of the neuroma. Cryoablation is performed in addition to standard trauma care and supportive therapy. Pain intensity, opioid consumption, functional outcomes, and patient-reported measures will be recorded before and after the procedure to evaluate efficacy and safety.

PROCEDURERadiofrequency ablation alone

Participants in this arm will receive image-guided radiofrequency ablation of the neuroma or affected peripheral nerve. The procedure involves percutaneous delivery of controlled thermal energy to modulate nerve function and reduce pain signal transmission. The number of treated nerve levels is determined based on the location and extent of the neuroma. Radiofrequency ablation is administered in addition to standard trauma care and supportive therapy. Pain intensity, opioid consumption, functional outcomes, and patient-reported measures will be recorded before and after the procedure to evaluate efficacy and safety.


Locations(1)

Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council

Rivne, Ukraine

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NCT07416448


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