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.
Age 18 years or older
Sustained combat-related trauma
Clinically significant neuroma-associated pain localized to a peripheral nerve or neuroma
Moderate to severe pain (score ≥ 4 on a standardized numeric pain rating scale)
Age under 18 years
Pregnant or breastfeeding
Severe uncontrolled medical comorbidities that preclude safe participation
Active infection at or near the proposed intervention site
Parallel
cryoablation
Procedure/SurgeryParticipants 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.
Radiofrequency ablation alone
Procedure/SurgeryParticipants 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.
Change in Pain Intensity Measured by Verbal Numeric Rating Scale (VNRS)
Pain intensity is assessed using the Verbal Numeric Rating Scale (VNRS), a validated 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain intensity. Change in pain intensity is evaluated by comparing VNRS scores across predefined time points.
Mechanical pain threshold
Assess mechanical pain threshold changes using Von Frey test
Opioid consumption
Compare opioid consumption
Evaluate quality of life and functional outcomes with Leeds Assessment of Neuropathic Symptoms and Signs LANS
Quality of life and functional outcomes were evaluated using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale. LANSS is a validated instrument designed to identify and quantify neuropathic pain and its functional impact. The scale consists of symptom-based questions and sensory examination items, with a total score ranging from 0 to 24. A score of 0 indicates no neuropathic pain features, while a score of 24 indicates the maximum severity of neuropathic pain features. Higher LANSS scores reflect greater neuropathic pain burden, increased functional impairment, and poorer quality of life, representing a worse outcome. Changes in LANSS scores were assessed over the study period to evaluate treatment-related effects.
Quality of life and functional outcomes were evaluated using the McGill Pain Questionnaire (MPQ)
Quality of life and functional outcomes were evaluated using the McGill Pain Questionnaire (MPQ), a validated multidimensional instrument assessing the sensory, affective, and evaluative components of pain and their impact on daily functioning. The total Pain Rating Index (PRI) derived from the MPQ ranges from 0 to 78, where 0 indicates no pain-related impact and 78 indicates the maximum pain-related impact. Higher scores represent greater pain intensity and functional impairment, corresponding to poorer quality of life and a worse outcome. Changes in MPQ scores were assessed over the study period to evaluate treatment-related effects.
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