Neuroma-Associated Pain Management After Combat-Related Trauma in Ukraine

NCT07416448 | Recruiting

• 1 other identifier: CMS-NAP-UA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management; Quality of Life; Neuroma; Functional Outcome; Depression in Adults; Neuropathic Pain; Hypoesthesia

Keywords

Neuroma Pain; Combat-Related Trauma; Cryoablation; Radiofrequency Ablation; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  4, 24, and 72 hours post-procedure.

Secondary Outcomes (11)

• Mechanical pain threshold

  Before and 72 hours after

• Opioid consumption

  before and 72 hours after ablation

• Evaluate quality of life and functional outcomes with Leeds Assessment of Neuropathic Symptoms and Signs LANS

  6 month after

• Quality of life and functional outcomes were evaluated using the McGill Pain Questionnaire (MPQ)

  6 mounth

• Quality of life and functional outcomes were evaluated using the Patient Health Questionnaire-9 (PHQ-9)

  6 mounth

Study Arms (2)

Cryoablation

ACTIVE COMPARATOR

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

Radiofrequency Ablation

ACTIVE COMPARATOR

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

Interventions

cryoablation PROCEDURE

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.

Radiofrequency Ablation

Radiofrequency ablation alone PROCEDURE

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.

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (1)

Communal enterprise "Yuri Semenyuk Rivne Regional Clinical Hospital" of Rivne Regional Council

Rivne, 33003, Ukraine

RECRUITING

Related Publications (1)

• Dmytriiev 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. 2025 Feb 26:rapm-2024-106307. doi: 10.1136/rapm-2024-106307. Online ahead of print.

  PMID: 39971386 RESULT

MeSH Terms

Conditions

Agnosia; Neuroma; Neuralgia; Hypesthesia

Interventions

Cryosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Somatosensory Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Radiofrequency Therapy; Therapeutics

Central Study Contacts

Maksym Barsa, MD, PhD

CONTACT

+380952074098; maksymbarsa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)