Evidence map›Paper›PMID 39728768›Full record

Trial reportToxins2024

The Lack of Effect of Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: A Short Report from the InTENSE Trial.

Ian D Cameron, Louise Ada, Maria Crotty, Mithu Palit, Lydia Huang, John Olver, Steven G Faux, Senen Gonzales, Brian Anthonisz, Malcolm Bowman and 6 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Toxins, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
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

16 authors.

Ian D CameronJohn Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, NSW 2065, Australia.ORCID 0000-0003-0147-047X
Louise AdaFaculty of Medicine and Health, University of Sydney, Camperdown, NSW 2050, Australia.ORCID 0000-0003-1369-5721
Maria CrottyCollege of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia.
Mithu PalitAlfred Health, Melbourne, VIC 3004, Australia.
Lydia HuangFlinders Medical Centre, Bedford Park, SA 5042, Australia.
John OlverEpworth Monash, Rehabilitation Research Unit, Richmond, VIC 3121, Australia.ORCID 0000-0001-7069-1191
Steven G FauxSacred Heart Rehabilitation, St Vincent's Hospital Sydney, Darlinghurst, NSW 2010, Australia.
Senen GonzalesAustin Hospital, Heidelberg, VIC 3084, Australia.
Brian AnthoniszAlfred Health, Melbourne, VIC 3004, Australia.
Malcolm BowmanSt Joseph's Hospital, St Vincent's HealthCare, East Sydney, NSW 2010, Australia.
Yuriko WatanabeSacred Heart Rehabilitation, St Vincent's Hospital Sydney, Darlinghurst, NSW 2010, Australia.ORCID 0000-0002-2608-3495
Yan ChowAustin Hospital, Heidelberg, VIC 3084, Australia.ORCID 0000-0002-9832-4737
Rachel MilteCaring Futures Institute, Flinders University, Bedford Park, SA 5042, Australia.
Julie RatcliffeCaring Futures Institute, Flinders University, Bedford Park, SA 5042, Australia.
Coralie K EnglishHeart and Stroke Program, School of Health Sciences, University of Newcastle, Callaghan, NSW 2308, Australia.
Natasha A LanninAlfred Health, Melbourne, VIC 3004, Australia.ORCID 0000-0002-2066-8345

Funding

Australian National Health and Medical Research Council GNT1079542
6 · The paper itself

Abstract

We examined the effect of botulinum toxin-A on upper limb impairments and activity limitations in chronic stroke. This study is a secondary analysis of control group data from a national, multicenter, Phase III randomized trial with a masked outcome assessment. We studied 71 stroke survivors who received a botulinum toxin-A injection in any muscle(s) that crosses the wrist due to significant spasticity after a stroke greater than 3 months previously. We measured upper limb activity, spasticity, range of motion, grip strength, pain and other outcomes at injection and three months later. The median difference between injection and 3 months later was 0.0 blocks/s (interquartile range (IQR) 0.0) on the Box and Block Test, 0/4 (IQR 1) on the Tardieu Scale, 4 degrees (IQR 26) of wrist extension, 0.0 kg (IQR 2) of grip strength, 0.0 (IQR 1.5) on the 10 cm visual analogue scale for pain, 0/100 (IQR 21) on the 10 cm visual analogue scale for overall health, 0/3 (IQR 0) for self-care and -2 (IQR 8) for burden of care. In chronic stroke survivors who have little activity in their upper limb, botulinum toxin-A is not effective in improving any measured outcomes and does not appear to be clinically justified in this population with severe activity limitations.

Indexed as

Botulinum Toxins, Type AMuscle SpasticityNeuromuscular AgentsStrokeUpper ExtremityAgedChronic DiseaseFemaleHand StrengthHumansMaleMiddle AgedRange of Motion, ArticularTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsbotulinum toxin type-Amovement painquality of liferehabilitationspasticitywrist

Identifiers

PMID39728768
PMCPMC11728757

What OpenQuestion holds

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Registered trials

None linked

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.