IADR Abstract Archives
Botulinum Toxin for Treatment of Painful Traumatic Trigeminal Neuropathy
Objectives: Peripheral painful traumatic trigeminal neuropathy (PPTTN), is poorly relieved by existing treatments. Botulinum toxin-A (BTX) has shown some efficacy for spinal neuropathic pain and trigeminal neuralgia but evidence is lacking for PPTTN (1) . The aim of this study was to evaluate the effect of BTX in PPTTN patients
Methods: A double blind randomized controlled clinical trial, with 2 parallel groups receiving either 0.2mL of BTX 50UI (Allergan®)(BTX) or saline (CTRL) injected intraorally at the location of pain, was performed in adult PTTN (2) patients (NCT03555916).
The main objective of the study was to evaluate the pain intensity 4 weeks after injection, self-recorded on a [0-10] numerical scale (NS) during 7 days. The secondary objectives and endpoints included assessment at 1, 3 and 6 months of 1) Pain intensity (NS) and quality (NPSI questionnaire), patients' overall impression of change (Lickert scale), area of pain, 2) Sensory changes using Quantitative Sensory Testing (3); 3) Emotional state (Hospital Anxiety and Depression Scale); 4) Movement and function (Brief Pain Inventory); 5) Quality of life (GOHAI and OHIP-14 questionnaires); 6) Assessment of safety with declaration of adverse effects.
Results: 40 patients were enrolled between 2019 and 2023 including 15 men and 5 women in each group, of mean age 53±14, with no significant differences between groups. Regarding the main objective, the pain score before treatment was 5±2 vs 5±1 in the CTRL and BTX groups respectively, and (5±.2 vs 4±2) after 1 month (p=0.685, Mann & Whitney test). Regarding secondary objectives, there were no statistically significant differences between neither pain nor other variables at the different time points.
Conclusion: No significant difference was evidenced between BTX and CTRL groups, indicating that this therapy is not effective in the tested conditions for PPTTN
Conclusions: No significant difference was evidenced between BTX and CTRL groups, indicating that this therapy is not effective in the tested conditions for PPTTN.
Refs (PMIDs): 1(28118416), 2(33945123), 3(21241350)
Methods: A double blind randomized controlled clinical trial, with 2 parallel groups receiving either 0.2mL of BTX 50UI (Allergan®)(BTX) or saline (CTRL) injected intraorally at the location of pain, was performed in adult PTTN (2) patients (NCT03555916).
The main objective of the study was to evaluate the pain intensity 4 weeks after injection, self-recorded on a [0-10] numerical scale (NS) during 7 days. The secondary objectives and endpoints included assessment at 1, 3 and 6 months of 1) Pain intensity (NS) and quality (NPSI questionnaire), patients' overall impression of change (Lickert scale), area of pain, 2) Sensory changes using Quantitative Sensory Testing (3); 3) Emotional state (Hospital Anxiety and Depression Scale); 4) Movement and function (Brief Pain Inventory); 5) Quality of life (GOHAI and OHIP-14 questionnaires); 6) Assessment of safety with declaration of adverse effects.
Results: 40 patients were enrolled between 2019 and 2023 including 15 men and 5 women in each group, of mean age 53±14, with no significant differences between groups. Regarding the main objective, the pain score before treatment was 5±2 vs 5±1 in the CTRL and BTX groups respectively, and (5±.2 vs 4±2) after 1 month (p=0.685, Mann & Whitney test). Regarding secondary objectives, there were no statistically significant differences between neither pain nor other variables at the different time points.
Conclusion: No significant difference was evidenced between BTX and CTRL groups, indicating that this therapy is not effective in the tested conditions for PPTTN
Conclusions: No significant difference was evidenced between BTX and CTRL groups, indicating that this therapy is not effective in the tested conditions for PPTTN.
Refs (PMIDs): 1(28118416), 2(33945123), 3(21241350)