Clinical trial · Interventional
Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine
Comprehensive Multicenter Study on the Management of Neuroma-Associated Pain Following Combat-Related Trauma in Ukraine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression in Adults | — | UNRESOLVED | — |
| Functional Outcome | — | UNRESOLVED | — |
| Hypoesthesia | — | UNRESOLVED | — |
| Neuroma | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
| Pain Management | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryoablation | Procedure | — | UNRESOLVED |
| Radiofrequency ablation alone | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cryoablation
- description
- 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.
- interventionNames
- Procedure: Radiofrequency ablation alone
- type
- ACTIVE_COMPARATOR
- label
- Radiofrequency Ablation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDmytriiev D, Liu W, Barsa M, Khomenko A, Strokan A, Pasquina PF, Cohen SP. Perineuromal hydrodissection for acute postamputation pain? An observational study in a time of war. Reg Anesth Pain Med. 2026 Jul 6;51(7):795-804. doi: 10.1136/rapm-2024-106307. PMID 39971386