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

Sponsor
Ukrainian Society of Regional Anesthesia and Pain Therapy
Study ID
NCT07416448
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cryoablation — PROCEDURE
    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.
  • Radiofrequency ablation alone — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
Feb 5, 2027
Completion
Feb 5, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: Radiofrequency Ablation
    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.

Primary Outcome Measure

Change in Pain Intensity Measured by Verbal Numeric Rating Scale (VNRS) [ Time Frame: 4, 24, and 72 hours post-procedure. ]

Central Contacts

Related Studies