Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine
Recruiting · NCT07416448 · Interventional (participants receive a specific treatment) · Lead sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
- Medically stable and able to undergo a percutaneous interventional procedure
- Able to understand and provide written informed consent
- Willing and able to comply with study procedures, including follow-up assessments and patient-reported outcome measures
- May be receiving standard analgesic therapy, including opioids, if usage can be monitored
- No planned surgical intervention at the neuroma site during the study period that could interfere with pain assessment
Exclusion criteria
- Age under 18 years
- Pregnant or breastfeeding
- Severe uncontrolled medical comorbidities that preclude safe participation
- Active infection at or near the proposed intervention site
- Known coagulopathy or use of anticoagulants that cannot be safely withheld
- Previous cryoablation or radiofrequency ablation at the target neuroma within the past 6 months
- Inability to provide informed consent or comply with study procedures
- Participation in another interventional clinical trial that could interfere with study outcomes
- Known allergy or intolerance to materials used during the procedures
Where it is running
1 location listed.
- Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council - Rivne, Ukraine