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Not Yet Recruiting NCT07626983

Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation

Conditions: Chronic Pain Due to Injury, Neuroma of Lower Limb, Neural Injury, Neuroma of Upper Limb, Combat Related Symptoms

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

Location: Feofaniya Clinical Hospital Kyiv Vinnytsia Oblast

Summary

Patients with combat-related amputations frequently experience persistent neuroma pain that may interfere with rehabilitation, prosthesis use, sleep, mobility, and quality of life. Current treatment options often provide only temporary relief. This study aims to compare two ultrasound-guided injection approaches for chronic neuroma pain after combat-related amputation: botulinum toxin type A and local anesthetic injection. Participants will be randomly assigned to receive one of the two treatments. Pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes will be evaluated during follow-up visits over a 24-week period. The goal of the study is to determine whether botulinum toxin type A provides longer-lasting pain reduction and improved functional recovery compared with local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years * Combat-related limb amputation * Persistent neuroma pain lasting ≥3 months * Ultrasound-confirmed neuroma * Positive Tinel sign over the neuroma * Average pain intensity ≥4/10 on the Numeric Rating Scale (NRS) * Stable analgesic regimen for at least 14 days before enrollment * Ability to provide written informed consent Exclusion Criteria: * Active infection at the injection site * Previous botulinum toxin injection within 6 months * Previous neuroma surgery within 3 months * Severe uncontrolled psychiatric disorder * Coagulopathy or anticoagulant therapy contraindicating injection * Known allergy to botulinum toxin or local anesthetics * Severe uncontrolled systemic disease * Inability to complete study follow-up or questionnaires

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07626983). StuddyBuddy aggregates publicly available trial information.