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Clinical Trial
. 2021 Mar;35(3):399-409.
doi: 10.1177/0269215520963855. Epub 2020 Oct 11.

Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial

Cameron Lindsay  1   2 , Sissi Ispoglou  3 , Brinton Helliwell  2 , Dawn Hicklin  3 , Steve Sturman  4 , Anand Pandyan  1
Affiliations
Clinical Trial

Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial

Cameron Lindsay et al. Clin Rehabil. 2021 Mar.

Abstract

Objective: Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function.

Design: Randomised placebo-controlled-trial.

Setting: Specialised stroke-unit.

Participants & intervention: Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment).

Outcome-measures: Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection.

Results: Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between -8.5(95% CI -17 to 0) to -9.4(95% CI -14 to -5) µV.Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI -0.7 to -12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively.Arm-function was not significantly different between the groups MD2.4 (95% CI -5.3 to 10.1) and 2.9 (95% CI -5.8 to 11.6) at week-12 and month-6 respectively.

Conclusion: BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function.

Trial registration: EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.

Keywords: Stroke; arm; botulinum toxin; spasticity; upper limb.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CL, ADP, SS and DH have all received honorarium and funding to attend courses from Allergan, Ipsen and Merz. SI and BH have no competing interests.

Figures

Figure 1.
Figure 1.
Consort flow chart summarising the flow of participants through the study. The last value was carried forward in case of missing values. SAH: subarachnoid heamorahhage; SOL: space occupying lesion.
See this image and copyright information in PMC

References

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