NCT07416448

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multicenter interventional study is designed to compare the safety and effectiveness of cryoablation and radiofrequency ablation in the management of neuroma-associated pain following combat-related trauma in adult patients treated at tertiary care centers in Vinnytsia, Rivne, and Lviv, Ukraine. Neuroma-associated pain is a neuropathic pain condition that often develops after peripheral nerve injury and is characterized by chronic or acute pain that can severely limit function, reduce quality of life, and increase reliance on opioid and other analgesic medications. Despite advances in pain management, there is limited high-quality comparative evidence regarding the relative benefits and risks of cryoablation versus radiofrequency ablation for acute and subacute neuroma pain, particularly in patients recovering from combat-related trauma. Cryoablation and radiofrequency ablation are minimally invasive, image-guided procedures that target peripheral nerves to reduce or block pain signal transmission. Cryoablation involves the application of extremely low temperatures to the neuroma or affected nerve, producing a temporary and reversible interruption of nerve conduction while preserving overall nerve structure. Radiofrequency ablation delivers controlled thermal energy to the target nerve, modulating nerve function and reducing pain signaling. Both interventions are performed percutaneously under image guidance, and the number of treated nerve levels is determined based on the anatomical distribution of the neuroma and clinical assessment. These interventions are delivered in addition to standard trauma care and supportive therapy according to institutional protocols. The study adopts a randomized, parallel assignment design. Eligible adult patients presenting with neuroma-associated pain following combat-related trauma are randomized to receive either cryoablation or radiofrequency ablation. Pain intensity is measured using validated scales at baseline and at predefined follow-up time points to capture both immediate and short-term effects of each intervention. Opioid and other analgesic use is recorded and standardized to allow comparisons between treatment arms. Pulmonary and functional measures, including incentive spirometry and pain provoked by movement or specific activities, are assessed where clinically relevant to evaluate the functional impact of pain reduction. Mechanical sensitivity of the affected area is measured using Von Frey testing to provide objective assessment of nociceptive changes. Patient-reported outcomes, including the LANS scale for neuropathic pain characteristics, the McGill Pain Questionnaire for qualitative pain assessment, and the PHQ-9 for depressive symptoms, are also collected to assess the multidimensional impact of pain and the effect of interventions on overall well-being. Demographic, clinical, and procedural variables are collected, including age, sex, body mass index, baseline pain intensity, neuroma location, and the number of nerve levels treated. These data allow for exploratory and adjusted analyses to identify factors associated with treatment response and clinically meaningful pain reduction. Data are entered into standardized electronic case report forms to ensure consistency and data quality across all participating centers. Safety monitoring is conducted throughout the study period. Both cryoablation and radiofrequency ablation are performed by clinicians experienced in interventional pain management, following established procedural safety protocols. Adverse events, including procedural complications and clinically significant changes in neurological function, are systematically documented and reviewed. The primary focus of safety assessment is on immediate and short-term complications related to the interventions, while longer-term follow-up may include monitoring for delayed adverse events associated with nerve-targeting procedures. The study is expected to generate clinically relevant evidence comparing the analgesic efficacy, functional impact, opioid-sparing potential, and safety profile of cryoablation versus radiofrequency ablation for neuroma-associated pain following combat-related trauma. Results will provide guidance for clinicians in selecting appropriate interventions for this patient population, support evidence-based pain management strategies, and contribute to improving patient outcomes by optimizing functional recovery and minimizing reliance on systemic analgesics.

Conditions

• Pain Management
• Quality of Life
• Neuroma
• Functional Outcome
• Depression in Adults
• Neuropathic Pain
• Hypoesthesia

Interventions

Type	Name	Description
PROCEDURE	cryoablation	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.
PROCEDURE	Radiofrequency 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.

Timeline

• Start date: 2026-02-05
• Primary completion: 2027-02-05
• Completion: 2027-02-05
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Ukraine