Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection (NCT07431944) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection
Ukraine100 participantsStarted 2026-02-15
Plain-language summary
Neuroma-related pain is a frequent and disabling condition after limb trauma and amputation. Available treatments often provide short-lasting or insufficient analgesia. The SILENCE-NEUROMA Trial is a multicenter, randomized, double-blind, active-controlled study designed to compare the efficacy and safety of botulinum toxin type A versus local anesthetic injection for the treatment of neuroma-related pain. The primary outcome is pain reduction at 8 weeks after treatment.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* History of limb trauma and/or limb amputation at least 3 months prior to enrollment
* Clinical diagnosis of neuroma-related pain with focal tenderness and positive - - Tinel sign
* Imaging confirmation of neuroma by ultrasound or MRI
* Average pain intensity ≥4 on a 0-10 Numerical Rating Scale (NRS) during the week prior to screening
* Stable analgesic regimen for at least 14 days prior to enrollment
* Ability to provide written informed consent
Exclusion Criteria:
* Chronic pain condition unrelated to neuroma that predominates clinical symptoms
* infection at or near the planned injection site
* Known neuromuscular junction disorders (e.g., myasthenia gravis)
* Pregnancy or breastfeeding
* Botulinum toxin treatment within the previous 4-6 months
* Planned surgical neuroma revision during the study period
* allergy or hypersensitivity to botulinum toxin or local anesthetics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)
Timeframe: Baseline (prior to injection) and Week 8 (56 ± 7 days) after injection
Trial details
NCT IDNCT07431944
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)