Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
2상
완료
NCT03848143
| 대상 질환 | Neuropathic Pain |
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| 임상 단계 | 2상 |
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| 스폰서 | Isabel Moreno Hay |
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| 상태 | 완료 |
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| 참여자 수 | 8 명 |
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| 중재(약물) | onabotulinum toxin A |
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| 시작일 | 2019년 9월 11일 |
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| 완료일 | 2025년 6월 30일 |
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| 결과 공개일 | 2026년 7월 30일 |
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요약
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain. HYPOTHESIS: There will be statistically significant differ
Change in Pain Intensity (Round 1)
Baseline, 3 month follow up · units on a scale
| BOTOX | 3.91 ± .86 units on a scale |
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Change in Pain Intensity (Round 2)
Baseline, 6 month follow up · units on a scale
| BOTOX | 3.33 ± 3.51 units on a scale |
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