Botulinum Toxin—A High-Dosage Effect on Functional Outcome and Spasticity-Related Pain in Subjects with Stroke
Abstract
:1. Introduction
2. Results
2.1. Functional Outcome
2.2. Spasticity-Related Pain
Study | Design | Patients/Sex/ Age | BTX-A Doses and Guidance/Follow-Up | Functional Measures and SRP Evaluation | Effect on Spasticity-Related Pain | Effect on Spasticity and Functional Outcome |
---|---|---|---|---|---|---|
Mancini et al., 2005 [25] | randomized, double-blind, study | N = 45 pts; N = 15 pts with onaBTX-A high dosage; (M 8, F 7) mean age 63.2 ± 10.1 | onaBTX-A (Botox) 540 ± 124.2 U; EMG; 4 months | MRC; MAS; VAS GT; GV; | improvement of pain | prolonged effect of BTX on spasticity, GV, gait function, pain, and presence of clonus |
Santamato et al., 2013 [26] | prospective | N = 25 12 F, 8 M; age (range 45–71 years) | incoBTX-A (Xeomin) 840 U (ranged from 750 to 840 U) in both UL and LL; UL muscles received a dosage of a maximum of 540 U; 340 U was administered in LL (range 250–340 U); US; 3 months | AS; DAS; GATR; VAS | improvement of SRP was observed for all patients | improvement of disability and muscle tone. Significant decrease evaluated after 30 and 90 days from the treatment (p < 0.05) to functional measures |
Invernizzi et al., 2014 [27] | case control | N = 11; 5 M, 6 F; age from 44 to 72 years | incoBTX-A (Xeomin) higher 600 U; 12 U/kg (range 600–800); NR | AS > 2; ECG for HRV (RR interval) | N/A | N/A |
Baricich et al., 2015 [28] | cohort; retrospective | N = 26; M 13, F 13; mean age 54.7 ± 11.6 | onaBTX-A (Botox) 600 IU; 13 pts > 700 IU; mean dose 676.9 ± 86.3 IU; US; 23 pts were treated at both upper and lower limbs; 3 months | MAS; DAS; GAE | N/A | significant reduction of spasticity (p < 0.0001). Improvement in DAS and GAE |
Santamato et al., 2017 [29] | cohort; prospective | 25 pts; 20 (12 F, 8 M); mean age 60.8 ± 7.8 | incoBTX-A (Xeomin); 830 U (ranged from 750 U to 830 U) in both upper and lower limb; US; UL received a dosage of a maximum of 560 U and LL a dosage of a maximum of 460 U (ranged from 260 U to 460 U); 2 years | AS; DAS GATR | the rate of patients that chose pain as the primary target of DAS was increased compared to the baseline: 39% and 24%, respectively | improvements as assessed on clinical scales for spasticity (AS), disability (DAS), and global assessment of treatment response (GATR) |
Wissel et al., 2017 [30] | prospective, single-arm, dose-titration study | mixed sample N = 155 pts M 104; F 51; mean age 53.7 ± 13.1 N = 132 with stroke; N = 23 other causes ^ | incoBTX-A (Xeomin); 400 to 800 IU; 36–48 weeks | AS; REPAS; GAS; | N/A | dosage up to 800 U was associated with increased treatment efficacy, improved muscle tone, and goal attainment |
Baricich et al., 2017 [31] | single-blind randomized controlled crossover study design | 10 pts; 7 M, 3 F; age 69 ± 10.5 | N = 5 onaBTX-A (Botox) 600 U (670 ± 83.67); N = 5 incoBTX-A (Xeomin) (660 ± 89.44); doses below 12 U/Kg | AS; BI; MI; FAC | N/A | N/A |
Ianieri et al., 2018 [32] | cohort, retrospective | mixed sample ° N = 120 N = 58 M 28, F 22; mean age 66 ± 3.2 | incoBTX-A (Xeomin) N = 58 received 700–1000 U (from 775.65 ± 30.45 to 986.65 ± 13.67); NR; 2 years | AS; FIM; MyotonPRO | N/A | reduction of spasticity and statistical improvement of FIM in 10 patients treated by 100–400 UI when the dosage increased up to 700 U |
Chiu SY et al., 2020 [33] | cohort, retrospective | mixed sample N = 68 pts F 43, M 25; N = 24 with spasticity *, N = 44 with dystonia | onaBTX-A (Botox) > 400 U receiving doses up to 800 U (range 425–800); 12 up 86 months | CGIS | N/A | all patients had a reduction of spasticity after the first treatment and the duration of benefit was 8.8 weeks ± 3.1 |
3. Discussion
4. Conclusions
5. Materials and Methods
Author Contributions
Funding
Institutional Review Board Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Intiso, D.; Centra, A.M.; Gravina, M.; Chiaramonte, A.; Bartolo, M.; Di Rienzo, F. Botulinum Toxin—A High-Dosage Effect on Functional Outcome and Spasticity-Related Pain in Subjects with Stroke. Toxins 2023, 15, 509. https://doi.org/10.3390/toxins15080509
Intiso D, Centra AM, Gravina M, Chiaramonte A, Bartolo M, Di Rienzo F. Botulinum Toxin—A High-Dosage Effect on Functional Outcome and Spasticity-Related Pain in Subjects with Stroke. Toxins. 2023; 15(8):509. https://doi.org/10.3390/toxins15080509
Chicago/Turabian StyleIntiso, Domenico, Antonello Marco Centra, Michele Gravina, Angelo Chiaramonte, Michelangelo Bartolo, and Filomena Di Rienzo. 2023. "Botulinum Toxin—A High-Dosage Effect on Functional Outcome and Spasticity-Related Pain in Subjects with Stroke" Toxins 15, no. 8: 509. https://doi.org/10.3390/toxins15080509