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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Age under 18 years

Pregnant or breastfeeding

Severe uncontrolled medical comorbidities that preclude safe participation

Active infection at or near the proposed intervention site

Trial design

Treatments tested in this trial

  • cryoablation
  • Radiofrequency ablation alone

Treatment groups

50 Participants
are divided into 2 treatment groups