Clinical trial · Interventional
Botulinum Toxin Type A for Neuroma Pain
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective treatment for painful neuromas. The ideal therapy for painful neuromas would be effective, non-addictive, safe, localized, and cost-effective treatment. At the same time, the therapy would also address the complex peripheral and central mechanisms. Btx-A is a potential treatment that addresses each of these requirements while preserving the existing sensation and function. Study Hypothesis: Btx-A injection relieves neuroma pain better than a placebo
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2nd phase - onabotulinum toxin type-A | Drug | — | UNRESOLVED |
| onabotulinum toxin type-A | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- onabotulinum toxin type-A
- description
- 1 injection of Btx-A, or up to 4 injections of Btx-A during the 1-year study period if pain recurs
- interventionNames
- Drug: onabotulinum toxin type-A
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- saline
- interventionNames
- Other: placebo
- type
- ACTIVE_COMPARATOR
- label
- 2nd phase - onabotulinum toxin type-A
- description
- 2 - 3 injections of Btx-A, specific to patient pain recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female * aged 18-75 years * diagnosed with neuroma pain * able to return/be available for follow-up evaluations * willingness and ability to give informed consent Exclusion Criteria: * positive for HIV/AIDS or otherwise immunocompromised * history of neuromuscular disease * reported allergy to BOTOX® * history or symptoms of any significant medical problem in the last year (i.e., bradycardia, impaired cardiovascular function, liver disease) * symptoms of infection or illness with initial enrollment * pregnant or lactating women * unable or unwilling to maintain abstinence or use contraception for 28 days following all injections * cognitively impaired patients unable to give informed consent
References
Publications (2)
- BACKGROUNDNeumeister MW. Botulinum toxin type A in the treatment of Raynaud's phenomenon. J Hand Surg Am. 2010 Dec;35(12):2085-92. doi: 10.1016/j.jhsa.2010.09.019. PMID 21134617
- BACKGROUNDNeumeister MW, Chambers CB, Herron MS, Webb K, Wietfeldt J, Gillespie JN, Bueno RA Jr, Cooney CM. Botox therapy for ischemic digits. Plast Reconstr Surg. 2009 Jul;124(1):191-201. doi: 10.1097/PRS.0b013e3181a80576. PMID 19568080