A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury

Sj, Smith; Ellis, Elizabeth; White, Sarah; Moore, Andrew R.

doi:10.1191/026921500666642221

Cited by 157 publications

(119 citation statements)

References 14 publications

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“…From the 98 selected papers, six fulfilled all inclusion criteria [8][9][10][11][12][13] . Despite one study 8 presented the described criteria, it was excluded from the metaanalysis because it did not present comparable data to be analysed ( Table 1).…”

Section: Resultsmentioning

confidence: 99%

Botulinum toxin type A for the treatment of the upper limb spasticity after stroke: a meta-analysis

Cardoso

Rodrigues

Lucena

et al. 2005

Arq. Neuro-Psiquiatr.

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Muscle over-activity is one of the cardinal features of spasticity and it is a common disability of stroke patients. In this group, spasticity is responsible for several limitations that interfere in their daily activities and quality of life. To treat spasticity, neurologists usually prescribe drugs as baclofen, tizanidine or benzodiazepines or even use definitive treatment as phenol or surgery. Authors suggest the use of botulinum toxin type A (BTX-A) for spasticity in the upper limbs after stroke, but there are few papers with adequate methodology supporting this idea. In this article we summarize the data of previous double-blind, randomised clinical trials to asses, with a meta-analysis, if BTX-A is an adequate treatment for spasticity due to stroke. The results show a statistical superiority of BTX-A ov%r placebo on reducing muscle tone by the Modified Ashworth Scale (WMD= 0.95 [0.74 to 1.17]) in patients with post-stroke upper limb spasticity.

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Section: Resultsmentioning

confidence: 99%

Botulinum toxin type A for the treatment of the upper limb spasticity after stroke: a meta-analysis

Cardoso

Rodrigues

Lucena

et al. 2005

Arq. Neuro-Psiquiatr.

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“…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.…”

Section: Findings Description Of Studiesmentioning

confidence: 99%

“…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.…”

Section: Findings Description Of Studiesmentioning

confidence: 99%

“…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.…”

Section: Findings Description Of Studiesmentioning

confidence: 99%

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

et al. 2009

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The aim of this systematic review was to determine whether botulinum neurotoxin (BoNT) reduce spasticity or improve function in adult patients after stroke. Eleven double-blind randomized placebo-controlled trials met inclusion criteria. They encompassed 782 patients, 767 (98%) of whom received BoNT/A, and 15 (2%) BoNT/B. Most studies used the Ashworth scale as primary outcome measure. Differences between treated and control groups were assessed as categorical or continuous comparisons. The overall effect on upper limb spasticity was in favor of BoNT/A. A significantly higher number of patients had a reduction of upper limb spasticity at 4-week and 8-week evaluations in the treatment group compared with placebo. Mean changes in joint spasticity revealed improvement 3 to 6 weeks and 9 to 12 weeks after treatment. There were insufficient data to establish BoNT/A efficacy on lower limb spasticity or the effect of BoNT/B on the upper and lower limbs. Because of inconsistency and heterogeneity of the available data, it was not possible to perform a meta-analysis on disability and patients' reported outcomes. There was an overlapping safety profile between the treatment and the placebo groups. BoNT/ A reduces upper limb spasticity in patients post-stroke, but the improvement in functional ability remains to be established. This gap needs to be filled by new studies to assess the effect of BoNT in the context of multidisciplinary patient management.2009 Movement Disorder Society

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“…Different treatment methods have been used for treatment of spasticity include physical therapy, oral anti-spastic drugs, chemical nerve block and motor point block using phenol or ethyl alcohol and botulinum toxin injection [5,6]. It has been reported that muscular injections of botulinum toxin type A decreases muscular tone in hypertonic muscles of the hand, with improvement in the use of the upper limb and a decrease in complications [7][8][9][10]. However, the development of neutralizing antibodies can reduce the efficacy of treatment.…”

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confidence: 99%

Effect of Different Energy Levels of Radial Shock Wave Therapy on Spasticity in Patients With Stroke

Fouda¹,

Mansour²

2018

IJPR

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Background and purpose: Spasticity in the hands and a wrist is a major problem in the management of stroke patients. Different energy levels of shock wave therapy (SWT) have been used for treatment of spasticity. So, the purpose of the study was to compare the effect of two different energy levels of radial SWT on spastic muscles of the hand and wrist in patients affected by stroke. Materials and Methods:Patients randomly assigned into two groups. Group A received the low energy radial SWT while group B received the medium energy radial SWT. Spasticity of wrist and fingers was evaluated using Modified Ashworth Scale (MAS), range of motion (ROM) of the wrist was evaluated using digital goniometer and pain was measured by Visual Analogue Scale (VAS).Results: there was a significant decrease in MAS scores of the wrist flexors and fingers flexors muscles post treatment for both groups (P<0.05). The ROM was significantly increased post treatment from (48.46±2.09) to (70.02±3.23) for group A and from (49.15±1.95) to (79.13±3.42) for group B. Also VAS scores was a significantly decreased in both groups post treatment. Conclusion:Radial SWT is an effective therapeutic tool in reducing flexor spasticity of the wrist and hand in patients with stroke. Moreover, the medium energy level was superior to the low energy level in regarding to the measured treatment outcomes.

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A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury

Abstract: Botulinum toxin produced beneficial effects in spasticity and passive range of movement in the hemiplegic upper limb. Increasing the dose increased the magnitude of response for impairments in some muscle groups but had little effect on duration of response.

Cited by 157 publications

References 14 publications

Botulinum toxin type A for the treatment of the upper limb spasticity after stroke: a meta-analysis

Botulinum toxin type A for the treatment of the upper limb spasticity after stroke: a meta-analysis

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

Effect of Different Energy Levels of Radial Shock Wave Therapy on Spasticity in Patients With Stroke

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