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Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation

Study acronym: IN-PERI NEUROM
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Start date changed from estimate of May 27, 2026 to Oct 1, 2026 Show 6 more changesShow less
    • Completed without a posted recruiting period
    • Primary completion date changed from estimate of May 27, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site contacts updated at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07624877
Lead Sponsor Ukrainian Society of Regional Anesthesia and Pain Therapy
Conditions
(from sponsor)
Chronic Pain, Neuroma, Botulinium Toxin-A, Combat Trauma
Related terms Chronic Pain, Neuroma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov