Evidence map›Paper›PMID 33040610›Full record

Trial reportClinical rehabilitation2021

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

Cameron Lindsay, Sissi Ispoglou, Brinton Helliwell, Dawn Hicklin, Steve Sturman, Anand Pandyan

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical rehabilitation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01882556 (Is it Clinically Effective to Treat Arm Flexor Spasticity, With Botulinum Toxin - Type A), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
2.0field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01882556 phase2completednot on this map

Is it Clinically Effective to Treat Arm Flexor Spasticity, With Botulinum Toxin - Type A (BoNTA) and Physiotherapy, as Soon as Signs of Abnormal Muscle Activity Are Observed?

TypeinterventionalSponsorSandwell & West Birmingham Hospitals NHS TrustRan2012 to 2014Enrolled120ConditionsStroke, Muscle Spasticity, ContractureArmsonabotulinumtoxinA, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
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  19. Botulinum neurotoxin as early treatment in acute-onset lesional hemiballism.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Cameron LindsaySchool of Allied Health Professions, Keele University, Staffordshire, UK.
Sissi IspoglouDepartment of Elderly Medicine, Sandwell Hospital, West Bromwich, West Midlands, UK.
Brinton HelliwellUlster Hospital, South Eastern HSC Trust, Belfast.
Dawn HicklinDepartment of Elderly Medicine, Sandwell Hospital, West Bromwich, West Midlands, UK.
Steve SturmanNeurology Department, Queen Elizabeth Hospital, Birmingham, UK.
Anand PandyanSchool of Allied Health Professions, Keele University, Staffordshire, UK.ORCID https://orcid.org/0000-0002-2180-197X
Sandwell General Hospital · GBUlster Hospital · GBKeele University · GBQueen Elizabeth Hospital Birmingham · GB

Funding

Department of Health PB-PG-0808-16319
6 · The paper itself

Abstract

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

designRandomised placebo-controlled-trial.

settingSpecialised stroke-unit. PARTICIPANTS &

interventionPatients 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.

resultsNinety 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.

conclusionBoNTA 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 registrationEudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.

Indexed as

AgedAged, 80 and overBotulinum Toxins, Type AContractureFemaleHand StrengthHumansMaleMiddle AgedMuscle SpasticityNeuromuscular AgentsSplintsStrokeWrist JointBotulinum Toxins, Type ANeuromuscular Agentsonabotulinum toxin Aarmbotulinum toxinspasticityStrokeupper limb

Identifiers

PMID33040610
PMCPMC7944432
OpenAlexW3092645710

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.