Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized, double-blind, placebo-controlled trial

Abstract

The placebo-controlled trial favours the concept that electrical stimulation enhances the effectiveness of BtxA in the treatment of chronic upper limb flexor spasticity after stroke.

Botulinum neurotoxins for post‐stroke spasticity in adults: A systematic review

“…23,24,26,28,29 Baseline spasticity was of comparable severity in the BoNT and placebo groups in seven trials, 11,21,23,24,26,27,29 whereas information on baseline clinical characteristics was considered insufficient in the other four studies. 7,10,25,28 Considering the potential relevance of concomitant drug treatments, rehabilitation, or devices, this information was not reported in seven trials, 7,11,21,24,[27][28][29] whereas one study indicated that no patient received concomitant therapy 23 and three studies reported no between-group differences. 10,25,26 In two studies, 23,29 all patients received a concomitant rehabilitation program.…”

“…7,10,25,28 Considering the potential relevance of concomitant drug treatments, rehabilitation, or devices, this information was not reported in seven trials, 7,11,21,24,[27][28][29] whereas one study indicated that no patient received concomitant therapy 23 and three studies reported no between-group differences. 10,25,26 In two studies, 23,29 all patients received a concomitant rehabilitation program. Information on clinical side effects and adverse events was reported in all trials, but severe adverse effects were a priori defined in one study only.…”

“…2B) Three studies with Dysport were not included in the meta-analysis of primary outcomes because standard deviations were not indicated. One of them 23 analyzed the efficacy of BoNT/A alone or combined with electrical stimulation: it was found that BoNT alone did not reduce Ashworth scores 2, 6, or 12 weeks after a total injection of 1,000 U in elbow, wrist, and finger flexors. The other trial 11 reported improvement in finger flexor spasticity 2, 6, or 12 weeks after a total injection of 1,000 Dysport U; elbow spasticity was reduced only at 2 weeks after treatment, but not at 6 or 12 weeks.…”

“…Concealment of treatment allocation was adequate in two trials 11,26 and unclear in the other nine. 7,10,21,[23][24][25][27][28][29] Blinding of patients and of the outcome assessor was poorly reported in four studies. 10,21,27,29 The Ashworth score was used as a primary outcome measure in all trials, but some trials used the scale as a continuous measure, 7,10,11,21,23,24,28 whereas others used it as a categorical measure.…”

“…7,10,21,[23][24][25][27][28][29] Blinding of patients and of the outcome assessor was poorly reported in four studies. 10,21,27,29 The Ashworth score was used as a primary outcome measure in all trials, but some trials used the scale as a continuous measure, 7,10,11,21,23,24,28 whereas others used it as a categorical measure. [25][26][27]29 Overall, 29 (3.7%) patients were excluded by the studies after randomization or loss to follow-up: in one study 21 no indication of allocation (BoNT vs. placebo) was given for two dropouts; in the other trials there were 15 BoNT-treated dropouts and 12 placebo-treated dropouts.…”