An interventional study of cryoablation and Radiofrequency ablation alone in Pain Management, Quality of Life and Neuroma, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Recruiting at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Not applicable, Interventional, and Treatment
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.
This multicenter interventional study is designed to compare the safety and effectiveness of cryoablation and radiofrequency ablation in the management of neuroma-associated pain following combat-related trauma in adult patients treated at tertiary care centers in Vinnytsia, Rivne, and Lviv, Ukraine. Neuroma-associated pain is a neuropathic pain condition that often develops after peripheral nerve injury and is characterized by chronic or acute pain that can severely limit function, reduce quality of life, and increase reliance on opioid and other analgesic medications. Despite advances in pain management, there is limited high-quality comparative evidence regarding the relative benefits and risks of cryoablation versus radiofrequency ablation for acute and subacute neuroma pain, particularly in patients recovering from combat-related trauma.
Cryoablation and radiofrequency ablation are minimally invasive, image-guided procedures that target peripheral nerves to reduce or block pain signal transmission. Cryoablation involves the application of extremely low temperatures to the neuroma or affected nerve, producing a temporary and reversible interruption of nerve conduction while preserving overall nerve structure. Radiofrequency ablation delivers controlled thermal energy to the target nerve, modulating nerve function and reducing pain signaling. Both interventions are performed percutaneously under image guidance, and the number of treated nerve levels is determined based on the anatomical distribution of the neuroma and clinical assessment. These interventions are delivered in addition to standard trauma care and supportive therapy according to institutional protocols.
The study adopts a randomized, parallel assignment design. Eligible adult patients presenting with neuroma-associated pain following combat-related trauma are randomized to receive either cryoablation or radiofrequency ablation. Pain intensity is measured using validated scales at baseline and at predefined follow-up time points to capture both immediate and short-term effects of each intervention. Opioid and other analgesic use is recorded and standardized to allow comparisons between treatment arms. Pulmonary and functional measures, including incentive spirometry and pain provoked by movement or specific activities, are assessed where clinically relevant to evaluate the functional impact of pain reduction. Mechanical sensitivity of the affected area is measured using Von Frey testing to provide objective assessment of nociceptive changes. Patient-reported outcomes, including the LANS scale for neuropathic pain characteristics, the McGill Pain Questionnaire for qualitative pain assessment, and the PHQ-9 for depressive symptoms, are also collected to assess the multidimensional impact of pain and the effect of interventions on overall well-being.
Demographic, clinical, and procedural variables are collected, including age, sex, body mass index, baseline pain intensity, neuroma location, and the number of nerve levels treated. These data allow for exploratory and adjusted analyses to identify factors associated with treatment response and clinically meaningful pain reduction. Data are entered into standardized electronic case report forms to ensure consistency and data quality across all participating centers.
Safety monitoring is conducted throughout the study period. Both cryoablation and radiofrequency ablation are performed by clinicians experienced in interventional pain management, following established procedural safety protocols. Adverse events, including procedural complications and clinically significant changes in neurological function, are systematically documented and reviewed. The primary focus of safety assessment is on immediate and short-term complications related to the interventions, while longer-term follow-up may include monitoring for delayed adverse events associated with nerve-targeting procedures.
The study is expected to generate clinically relevant evidence comparing the analgesic efficacy, functional impact, opioid-sparing potential, and safety profile of cryoablation versus radiofrequency ablation for neuroma-associated pain following combat-related trauma. Results will provide guidance for clinicians in selecting appropriate interventions for this patient population, support evidence-based pain management strategies, and contribute to improving patient outcomes by optimizing functional recovery and minimizing reliance on systemic analgesics.
Exclusion Criteria:
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.
Procedure: Radiofrequency ablation alone
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.
Procedure: 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.
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.
Change in Pain Intensity Measured by Verbal Numeric Rating Scale (VNRS)
Pain intensity is assessed using the Verbal Numeric Rating Scale (VNRS), a validated 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain intensity. Change in pain intensity is evaluated by comparing VNRS scores across predefined time points.
Time frame: 4, 24, and 72 hours post-procedure.
Mechanical pain threshold
Assess mechanical pain threshold changes using Von Frey test
Time frame: Before and 72 hours after
Opioid consumption
Compare opioid consumption
Time frame: before and 72 hours after ablation
Evaluate quality of life and functional outcomes with Leeds Assessment of Neuropathic Symptoms and Signs LANS
Quality of life and functional outcomes were evaluated using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale. LANSS is a validated instrument designed to identify and quantify neuropathic pain and its functional impact. The scale consists of symptom-based questions and sensory examination items, with a total score ranging from 0 to 24. A score of 0 indicates no neuropathic pain features, while a score of 24 indicates the maximum severity of neuropathic pain features. Higher LANSS scores reflect greater neuropathic pain burden, increased functional impairment, and poorer quality of life, representing a worse outcome. Changes in LANSS scores were assessed over the study period to evaluate treatment-related effects.
Time frame: 6 month after
Quality of life and functional outcomes were evaluated using the McGill Pain Questionnaire (MPQ)
Quality of life and functional outcomes were evaluated using the McGill Pain Questionnaire (MPQ), a validated multidimensional instrument assessing the sensory, affective, and evaluative components of pain and their impact on daily functioning. The total Pain Rating Index (PRI) derived from the MPQ ranges from 0 to 78, where 0 indicates no pain-related impact and 78 indicates the maximum pain-related impact. Higher scores represent greater pain intensity and functional impairment, corresponding to poorer quality of life and a worse outcome. Changes in MPQ scores were assessed over the study period to evaluate treatment-related effects.
Time frame: 6 mounth
Quality of life and functional outcomes were evaluated using the Patient Health Questionnaire-9 (PHQ-9)
Quality of life and functional outcomes were evaluated using the Patient Health Questionnaire-9 (PHQ-9), a validated self-reported instrument used to assess the severity of depressive symptoms and their impact on daily functioning and overall quality of life. The PHQ-9 total score ranges from 0 to 27, where 0 indicates no depressive symptoms and 27 indicates severe depressive symptoms. Higher scores represent greater symptom severity, increased functional impairment, and poorer quality of life, corresponding to a worse outcome. Changes in PHQ-9 scores were assessed over the study period to evaluate treatment-related effects.
Time frame: 6 mounth
Change in Functional Mobility Measured by Goniometric Range of Motion and Functional Activity Scale
Functional mobility is assessed by measuring active range of motion of the affected region using a standard clinical goniometer (degrees of movement) and by recording performance on a standardized functional activity scale (0-10 numeric rating of activity limitation). Higher goniometric values indicate greater range of motion, and higher functional activity scores indicate greater activity limitation. Change in functional mobility is evaluated by comparing measurements obtained at baseline and predefined post-procedure time points.
Time frame: Baseline and 72 hours post-procedure
Change in Sleep Quality Measured by Numeric Rating Scale
Sleep quality is assessed using a Sleep Quality Numeric Rating Scale, an 11-point scale ranging from 0 to 10, where 0 indicates "worst possible sleep quality" and 10 indicates "best possible sleep quality." Higher scores indicate better sleep quality. Change in sleep quality is evaluated by comparing scores obtained at baseline and predefined post-procedure time points.
Time frame: Baseline and 72 hours post-procedure
Patient Global Impression of Change Score
Patient status is assessed using the Patient Global Impression of Change scale, a standardized 7-point Likert scale ranging from 1 to 7, where 1 indicates "very much worse," 4 indicates "no change," and 7 indicates "very much improved." Higher scores indicate greater perceived improvement. Scores obtained at predefined post-procedure time points are recorded and analyzed to characterize patient-reported global status following intervention.
Time frame: 72 hours post-procedure
Local Procedure Site Reaction / Adverse Events
Documentation of local complications such as bruising, swelling, soreness, or sensory changes at the site of nerve intervention to assess procedural safety.
Time frame: Immediate post-procedure and 72 hours
Time to First Rescue Analgesic
Time from procedure to first use of additional analgesics (other than baseline opioids) to evaluate the duration of pain relief provided by each intervention.
Time frame: Up to 72 hours post-procedure
Change in Functional Pain Interference Measured by Brief Pain Inventory Interference Scale
Functional impact of pain is assessed using the Brief Pain Inventory Interference Scale, a validated patient-reported outcome measure consisting of seven items evaluating pain interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Each item is scored on an 11-point numeric scale ranging from 0 to 10, where 0 indicates "does not interfere" and 10 indicates "completely interferes." Higher scores indicate greater pain-related interference. Change in functional pain interference is evaluated by comparing scores obtained at baseline and predefined post-procedure time points.
Time frame: Baseline and 72 hours post-procedure
Plan to share: No
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Ukrainian Society of Regional Anesthesia and Pain Therapy