Botulinum toxin type A for upper limb spasticity following stroke: an open-label study with individualised, flexible injection regimens

Abstract

Current antispastic medications are unsatisfactory for spasticity treatment, but botulinum toxin type A (BTX-A) shows promise as a new therapeutic option. This open-label, prospective study aimed to assess the effectiveness of BTX-A in improving functional mobility in the early post-stroke population using an individualised, flexible range of doses and targeted muscle groups. Twenty-one stroke patients (13 male, 8 female) were enrolled and injected with BTX-A (Botox, Allergan, mean dose: 255 U; range: 185-300) according to individual spasticity patterns. Assessments were made at baseline and weeks 2, 4, 6, 10 and 16 post-treatment. Outcome measures comprised: Modified Ashworth Scale (MAS), finger flexion scale (Bhakta), MRC scale, Physician's Rating Scale (PRS), Nine Hole Peg Test (9HPT), Motor Assessment Scale, Clinical Global Impression (CGI), Global Assessment of Spasticity (GASS) and Visual Analogue Scale (VAS) for pain assessment. Statistically significant improvements in muscle tone as determined by the MAS were found in all areas (except arm) till week 16 (p<0.05). Finger positioning improved for the study duration, whilst muscle power increased only slightly in specific muscles. PRS revealed significant improvements to week 10 and slight improvement in 9HPT performance in selected patients was observed. Motor Assessment Scale results were statistically significant for arm, hand and advanced hand functions, although the overall functional benefit was mild. GASS and CGI results also showed improvement. Pain was present only in 11 patients and did not significantly improve following treatment. Individualised BTX-A injection regimens may be an effective, reversible and safe new treatment option for patients with spasticity. Nevertheless, functional improvement may be reached only in selected patients.

Botulinum toxin A modifies nociceptive withdrawal reflex in subacute stroke patients

“…Botulinum toxin is routinely used to treat focal spastic hypertonia in various upper motor neuron disorders (Esquenazi et al., 2013; Simpson et al., 1996). Indeed, peripheral injection of botulinum toxin type A (BoNT‐A) is one available treatment for focal problematic spastic hypertonia and associated pain, and it is particularly effective on upper limb spasticity in the subacute phase after stroke (Gracies et al., 2015; Slawek, Bogucki, & Reclawowicz, 2005). Physiotherapy in the subacute phase can further prolong the positive effect induced by botulinum toxin injection (Han, Wang, Meng, & Qi, 2013; Kinnear, Lannin, Cusick, Harvey, & Rawicki, 2014).…”

“…These plastic changes lead, on the one hand, to the development of spasticity, and, on the other hand, to motor recovery (Pin‐Barre & Laurin, 2015). In theory, treating spasticity with BoNT‐A from the early poststroke phase may improve the outcome of a rehabilitation intervention and further promote motor recovery (Slawek et al., 2005). From this perspective, it is extremely important to quantitatively evaluate spinal plastic changes induced by early BoNT‐A treatment.…”

Effect of Upper Limb Botulinum Toxin Injections on Impairment, Activity, Participation, and Quality of Life Among Stroke Patients

“…1 Certain studies claim to identify functional effects of BoNT-A injections with the Frenchay Arm Test 5 or the Disability Assessment Scale (DAS) 2,3 and have shown variable results. 6 However, such instruments do not focus on activity and certain domains measured by the DAS (eg, pain and palmar infection) refer to impairment and not to functional upper limb abilities. The study by Brashear 3 was criticized, 6,7 because of its lack of clarity regarding the term "functional disability," and because of the limited improvement recorded in a subjective and narrow band of patient disabilities.…”

The Evaluation of Botulinum Toxin Injection Effect for Poststroke Spasticity Treatment

“…Neutralizing antibodies should be considered in patients who are unresponsive to repeated injections of BTX-A in the long term (38). We did not observe adverse effects due to BTX-A in our study.…”