Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07416448

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

Led by Ukrainian Society of Regional Anesthesia and Pain Therapy · Updated on 2026-02-18

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 64 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council

Rivne, Ukraine, 33003

Actively Recruiting

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Research Team

M

Maksym Barsa, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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