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NCT07624877
Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation
Conditions: Chronic Pain, Neuroma, Botulinium Toxin-A, Combat Trauma
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
Summary
Patients with combat-related amputations frequently experience chronic neuroma pain that may interfere with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a potential treatment option for persistent neuroma pain; however, the optimal injection technique remains unclear.
This prospective multicenter study aims to compare two ultrasound-guided botulinum toxin injection techniques for chronic neuroma pain after combat-related amputation: intraneuroma injection and perineuroma injection.
Participants with ultrasound-confirmed painful neuromas will undergo one of the two injection approaches based on the treating physician's clinical decision and local practice. Pain intensity, neuropathic pain characteristics, phantom limb pain, prosthesis tolerance, functional outcomes, and adverse events will be evaluated during follow-up.
The goal of the study is to evaluate the feasibility, safety, and potential clinical effectiveness of intraneuroma and perineuroma botulinum toxin type A injection techniques in patients with chronic neuroma pain following combat-related amputation.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Combat-related limb amputation
* Chronic neuroma pain lasting ≥3 months
* Ultrasound-confirmed painful neuroma
* Average neuroma pain intensity ≥4/10 on the Numeric Rating Scale
* Ability to undergo ultrasound-guided injection
* Stable analgesic regimen for at least 14 days before enrollment
* Ability to provide written informed consent
Exclusion Criteria:
* Active infection at or near the injection site
* Open wound preventing safe injection
* Previous botulinum toxin injection for neuroma pain within 6 months
* Previous neuroma surgery within 3 months
* Known allergy to botulinum toxin type A
* Coagulopathy or anticoagulation contraindicating injection
* Severe uncontrolled systemic disease
* Inability to complete follow-up assessments
Source: ClinicalTrials.gov (NCT07624877). StuddyBuddy aggregates publicly available trial information.
