Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation
Not yet recruitingNot applicableNCT07626983
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Multicenter Randomized Double-Blind Trial
- Conditions
- Chronic Pain Due to Injury
- Neuroma of Lower Limb
- Neural Injury
- Neuroma of Upper Limb
- Combat Related Symptoms
- Interventions
- Drug: Botulinum Toxin Type A (BoNT-A)
- Drug: Local Anesthetic Solution
- Sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Start date
- 2026-05-30
- Primary completion
- 2026-12-15
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Ukraine
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07626983