Comparing cryoablation versus radiofrequency ablation for neuroma pain after combat injuries
Comprehensive Multicenter Study on the Management of Neuroma-Associated Pain Following Combat-Related Trauma in Ukraine
This study will try cryoablation or radiofrequency ablation to see if one reduces neuroma-related pain and opioid use in adults with combat-related nerve injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ukrainian Society of Regional Anesthesia and Pain Therapy Academic / other |
| Locations | 1 site (Rivne) |
| Trial ID | NCT07416448 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized interventional study in Ukraine assigns adults with clinically significant neuroma-associated pain after combat trauma to image-guided cryoablation or radiofrequency ablation of the affected nerve. Both procedures are minimally invasive, percutaneous treatments performed under imaging to target the neuroma or involved peripheral nerve. The study measures changes in pain intensity, opioid consumption, functional outcomes, and patient-reported quality of life and mood at predefined follow-up time points. The goal is a direct comparison of safety and effectiveness between the two ablation approaches in tertiary care centers in Vinnytsia, Rivne, and Lviv.
Who should consider this trial
Good fit: Adults (18+) with combat-related peripheral neuroma pain rated moderate to severe who are medically stable and able to undergo a percutaneous, image-guided nerve ablation and follow-up evaluations.
Not a fit: Patients with non-neuroma pain sources, severe uncontrolled comorbidities, active infection at the intervention site, uncorrectable coagulopathy, or who cannot attend follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify which procedure better reduces neuroma pain, improves function, and lowers reliance on opioid medications.
How similar studies have performed: Both cryoablation and radiofrequency ablation have shown benefit for peripheral neuroma or neuropathic pain in case series and small trials, but high-quality head-to-head comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rivne
- Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council — Rivne, Ukraine (Recruiting)
Study contacts
- Study coordinator: Maksym Barsa, MD, PhD
- Email: maksymbarsa@gmail.com
- Phone: +380952074098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.