Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine (NCT07416448) | Clinical Trial Compass
RecruitingNot Applicable
Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine
Ukraine50 participantsStarted 2026-02-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Measured by Verbal Numeric Rating Scale (VNRS)
Timeframe: 4, 24, and 72 hours post-procedure.
Trial details
NCT IDNCT07416448
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy