Lindsay, C, Ispoglou, S, Helliwell, B, Hicklin, D, Sturman, S and Pandyan, A ORCID: https://orcid.org/0000-0002-2180-197X (2020) Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial. Clinical Rehabilitation.

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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.

Item Type: Article
Uncontrolled Keywords: Stroke; spasticity; botulinum toxin; arm; upper limb
Subjects: R Medicine > RM Therapeutics. Pharmacology > RM930 Rehabilitation therapy
Divisions: Faculty of Medicine and Health Sciences > School of Allied Health Professions
Depositing User: Symplectic
Date Deposited: 20 Oct 2020 15:10
Last Modified: 29 Oct 2020 12:10
URI: https://eprints.keele.ac.uk/id/eprint/8811

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