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This study is a multicenter clinical trial conducted in Vinnytsia, Rivne, and Lviv, Ukraine, focusing on the management of acute pain following thoracic injuries sustained during combat. The main purpose of the study is to evaluate and compare the effectiveness and safety of two minimally invasive procedures, cryoablation and radiofrequency ablation, in controlling severe chest pain and improving patients' recovery. Cryoablation involves applying extreme cold to specific intercostal nerves to reduce pain signals, while radiofrequency ablation uses controlled heat to achieve a similar effect. Both procedures target the nerves responsible for transmitting pain from the injured areas and are performed by experienced clinicians under careful monitoring to minimize risks. Adult patients who have experienced thoracic combat trauma and are experiencing moderate to severe pain may be eligible to participate in the study if they are able to provide informed consent and comply with the study procedures. Participants will be randomly assigned to receive either cryoablation or radiofrequency ablation. Pain intensity will be assessed before the procedure, and then again at four, twenty-four, and seventy-two hours afterward using a standardized verbal numeric rating scale. In addition to measuring changes in pain, the study will monitor opioid medication use to determine whether either procedure reduces the need for pain-relieving drugs. Mechanical pain sensitivity will be evaluated using Von Frey testing, and pulmonary function will be assessed using incentive spirometry to determine whether pain reduction improves the ability to breathe deeply and cough effectively. The impact of pain on daily activities, quality of life, and emotional well-being will also be measured using validated tools such as the LANS scale, the McGill Pain Questionnaire, and the PHQ-9 depression screening questionnaire. The study aims to provide important information on the relative benefits and risks of cryoablation and radiofrequency ablation for the treatment of acute thoracic pain, including changes in pain intensity, opioid consumption, respiratory function, and overall comfort. Potential risks associated with the procedures include temporary soreness, bruising, or rare complications, but all interventions are performed under strict safety protocols. Participation in this study may allow patients to experience better pain control, potentially reduced reliance on opioid medications, and faster recovery, while contributing valuable data that could improve pain management strategies for other patients in similar circumstances. Data collected during the study will be analyzed to compare the effectiveness of the two procedures and to identify factors that may influence outcomes, such as age, body mass index, the number of intercostal levels treated, and baseline pain scores. The study provides a structured, evidence-based approach to understanding acute pain management after thoracic combat injuries and aims to support clinicians in making informed decisions to improve patient care. For patients, families, and healthcare providers, this research offers an opportunity to participate in a carefully monitored clinical trial designed to enhance recovery and reduce suffering after serious chest trauma while advancing medical knowledge in the field of pain management.
Full description
This study is a prospective, multicenter clinical investigation designed to compare cryoablation and radiofrequency ablation as interventional techniques for the management of acute pain following thoracic combat-related trauma in adult patients treated in Ukraine. Thoracic injuries sustained during combat are commonly associated with severe acute pain, which can negatively affect respiratory mechanics, impair coughing and mobilization, increase opioid requirements, and contribute to pulmonary complications and prolonged recovery. Effective and timely pain control is therefore a critical component of trauma care in this patient population.
Cryoablation and radiofrequency ablation are minimally invasive procedures that target peripheral nerves involved in pain transmission, most commonly intercostal nerves in the setting of thoracic trauma. Cryoablation induces a temporary and reversible disruption of nerve conduction through localized application of extreme cold, while radiofrequency ablation produces thermal modulation of nerve function using controlled radiofrequency energy. Both techniques aim to provide targeted analgesia while reducing reliance on systemic analgesics, particularly opioids. Although both approaches are used in clinical practice, comparative evidence regarding their effectiveness, functional impact, and opioid-sparing potential in patients with acute thoracic combat trauma remains limited.
The study will be conducted at multiple tertiary care centers in Vinnytsia, Rivne, and Lviv. Adult patients presenting with thoracic combat-related trauma and clinically significant acute pain will be screened for eligibility and enrolled after providing informed consent. Participants will be randomly assigned to receive either cryoablation or radiofrequency ablation as part of their acute pain management, in addition to standard trauma care according to institutional protocols. The selection of intercostal levels for treatment will be based on injury distribution and clinical assessment, following a standardized procedural approach to ensure consistency across centers.
Pain intensity will be assessed using the Verbal Numeric Rating Scale at baseline prior to intervention and at predefined time points after the procedure to evaluate early and short-term analgesic effects. Opioid consumption will be recorded before intervention and during follow-up and standardized to allow comparison between treatment groups. Because thoracic pain directly affects respiratory function, pulmonary performance will be evaluated using incentive spirometry before and after the intervention to assess changes in airflow and the ability to perform deep breathing and coughing maneuvers.
Mechanical pain sensitivity will be assessed using Von Frey testing to evaluate changes in nociceptive thresholds following treatment. Pain provoked by coughing, a clinically relevant indicator of functional pain control in thoracic trauma, will be measured using a visual analog scale. In addition, patient-reported outcome measures will be collected using validated instruments, including the LANS scale for neuropathic pain features, the McGill Pain Questionnaire for qualitative pain assessment, and the PHQ-9 to screen for depressive symptoms that may influence pain perception and recovery.
Demographic and clinical variables, including age, body mass index, baseline pain severity, and the number of intercostal levels treated, will be collected to support exploratory and adjusted analyses. Data will be entered into a standardized electronic case report form to ensure data quality and consistency across sites. Statistical analyses will include assessment of within-group changes over time and between-group comparisons of pain reduction, opioid use, respiratory function, and patient-reported outcomes. Multivariable analyses may be performed to identify factors associated with treatment response and clinically meaningful pain reduction.
Safety will be monitored throughout the study period. All procedures will be performed by clinicians experienced in interventional pain management techniques, following established institutional and procedural safety standards. Adverse events related to the interventions will be documented and reviewed. Given the acute nature of the intervention and follow-up period, safety assessments will focus on immediate and early procedural complications.
This study aims to generate clinically relevant evidence regarding the comparative effectiveness and safety of cryoablation and radiofrequency ablation for acute pain management following thoracic combat-related trauma. The results are expected to inform clinical decision-making, support optimization of pain management strategies, reduce opioid exposure, and improve functional recovery in this high-risk patient population.
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50 participants in 2 patient groups
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Dmytro Dmytriiev, PhD, Dr.med.science, professor; Maksym Barsa, MD, PhD
Data sourced from clinicaltrials.gov
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