Perineuromal hydrodissection for acute postamputation pain? An observational study in a time of war.
Dmytro Dmytriiev, Winnie Liu, Maksym Barsa...
https://pubmed.ncbi.nlm.nih.gov/39971386Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07416448
Comprehensive Multicenter Study on the Management of Neuroma-Associated Pain Following 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two minimally invasive procedures, cryoablation and radiofrequency ablation, to manage neuroma-associated pain in adults who have experienced combat-related trauma. This multicenter study in Ukraine focuses on patients with significant neuropathic pain caused by neuromas. The goal is to assess which procedure better reduces pain, improves function, and decreases opioid use in this patient population. Participants are randomly assigned to receive either image-guided cryoablation, which uses cold temperatures to temporarily disrupt nerve signals while preserving nerve structure, or radiofrequency ablation, which applies thermal energy to modulate nerve function and reduce pain transmission. Both procedures are performed percutaneously and added to standard trauma care and supportive therapy. The number of nerve levels treated depends on the location and extent of the neuroma. Throughout the study, pain intensity is measured at various time points, including 4, 24, and 72 hours after the procedure, using a verbal numeric rating scale. Researchers also track opioid use, mechanical pain sensitivity, functional mobility, sleep quality, and patient-reported outcomes related to neuropathic pain characteristics, pain quality, and depressive symptoms. Safety is monitored for immediate and short-term complications, with follow-up assessments up to six months after treatment. The total study period extends until February 2027.
CONDITIONS
Brief Title
Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
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 2 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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with assessments up to 72 hours post-procedure
Participants receive either image-guided cryoablation or radiofrequency ablation of the neuroma or affected peripheral nerve. These minimally invasive procedures are performed percutaneously under image guidance to reduce pain by modulating nerve function. The number of treated nerve levels depends on the neuroma location and extent. Treatment is given in addition to standard trauma care and supportive therapy.
1 procedure visit and follow-up visits within 72 hours
Follow-up
Duration - Up to 6 months
Participants are monitored to assess pain intensity, opioid use, functional outcomes, and quality of life using various patient-reported and clinical measures. Follow-up includes assessments at 72 hours post-procedure and additional evaluations up to 6 months to evaluate long-term effects and safety.
Visits at 72 hours and at 6 months post-procedure
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
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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