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^{1

2}, Louise Ada², Maria Crotty^{3

4}, Mithu Palit⁵, Lydia Huang⁴, John Olver⁶, Steven G Faux^{7

8}, Senen Gonzales⁹, Brian Anthonisz⁵, Malcolm Bowman¹⁰, Yuriko Watanabe⁷, Yan Chow⁹, Rachel Milte¹¹, Julie Ratcliffe¹¹, Coralie K English^{12

13}, Natasha A Lannin^{5

14}

Affiliations

¹ John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, NSW 2065, Australia.
² Faculty of Medicine and Health, University of Sydney, Camperdown, NSW 2050, Australia.
³ College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia.
⁴ Flinders Medical Centre, Bedford Park, SA 5042, Australia.
⁵ Alfred Health, Melbourne, VIC 3004, Australia.
⁶ Epworth Monash, Rehabilitation Research Unit, Richmond, VIC 3121, Australia.
⁷ Sacred Heart Rehabilitation, St Vincent's Hospital Sydney, Darlinghurst, NSW 2010, Australia.
⁸ St Vincent's Clinical School, University of New South Wales, Sydney, NSW 2033, Australia.
⁹ Austin Hospital, Heidelberg, VIC 3084, Australia.
¹⁰ St Joseph's Hospital, St Vincent's HealthCare, East Sydney, NSW 2010, Australia.
¹¹ Caring Futures Institute, Flinders University, Bedford Park, SA 5042, Australia.
¹² Heart and Stroke Program, School of Health Sciences, University of Newcastle, Callaghan, NSW 2308, Australia.
¹³ Hunter Medical Research Institute, New Lambton Heights, NSW 2305, Australia.
¹⁴ Department of Neurosciences, Central Clinical School, Monash University, Clayton, VIC 3800, Australia.

PMID: 39728768
PMCID: PMC11728757
DOI: 10.3390/toxins16120510

Clinical Trial

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 et al. Toxins (Basel). 2024.

. 2024 Nov 26;16(12):510.

doi: 10.3390/toxins16120510.

Authors

Affiliations

¹ John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, NSW 2065, Australia.
² Faculty of Medicine and Health, University of Sydney, Camperdown, NSW 2050, Australia.
³ College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia.
⁴ Flinders Medical Centre, Bedford Park, SA 5042, Australia.
⁵ Alfred Health, Melbourne, VIC 3004, Australia.
⁶ Epworth Monash, Rehabilitation Research Unit, Richmond, VIC 3121, Australia.
⁷ Sacred Heart Rehabilitation, St Vincent's Hospital Sydney, Darlinghurst, NSW 2010, Australia.
⁸ St Vincent's Clinical School, University of New South Wales, Sydney, NSW 2033, Australia.
⁹ Austin Hospital, Heidelberg, VIC 3084, Australia.
¹⁰ St Joseph's Hospital, St Vincent's HealthCare, East Sydney, NSW 2010, Australia.
¹¹ Caring Futures Institute, Flinders University, Bedford Park, SA 5042, Australia.
¹² Heart and Stroke Program, School of Health Sciences, University of Newcastle, Callaghan, NSW 2308, Australia.
¹³ Hunter Medical Research Institute, New Lambton Heights, NSW 2305, Australia.
¹⁴ Department of Neurosciences, Central Clinical School, Monash University, Clayton, VIC 3800, Australia.

PMID: 39728768
PMCID: PMC11728757
DOI: 10.3390/toxins16120510

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.

Keywords: botulinum toxin type-A; movement pain; quality of life; rehabilitation; spasticity; wrist.

PubMed Disclaimer

Conflict of interest statement

J Olver and S Gonzalez declare that they have received honoraria from Allergan; J Olver, M Palit and S Gonzalez declare that they have received honoraria from Ipsen; S Gonzalez declares that he has received honoraria from Merz. The other authors report no conflicts of interest. The funders had no role in the design of the study; in the collection, analyses or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

References

1. Stroke Foundation Clinical Guidelines for Stroke Management; Melbourne, Australia, 2024. [(accessed on 4 November 2024)]. Available online: https://informme.org.au/Guidelines/Clinical-Guidelines-for-Stroke-Manage....
1. Royal College of Physicians, British Society of Rehabilitation Medicine, The Chartered Society of Physiotherapy, Association of Chartered Physiotherapists in Neurology and the Royal College of Occupational Therapists . Spasticity in Adults: Management Using Botulinum Toxin. Royal College of Physicians; London, UK: 2018. National Guidelines.
1. Lannin N.A., Ada L., English C., Ratcliffe J., Faux S.G., Palit M., Gonzalez S., Olver J., Cameron I., Crotty M. Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial. Stroke. 2020;51:556–562. doi: 10.1161/STROKEAHA.119.027602. - DOI - PMC - PubMed
1. Foley N., Pereira S., Salter K., Fernandez M.M., Speechley M., Sequeira K., Miller T., Teasell R. Treatment with botulinum toxin improves upper-extremity function post stroke: A systematic review and meta-analysis. Arch. Phys. Med. Rehabil. 2013;94:977–989. doi: 10.1016/j.apmr.2012.12.006. - DOI - PubMed
1. Lannin N.A., Ada L., English C., Ratcliffe J., Crotty M. Effect of adding upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: Protocol for the InTENSE trial. Int. J. Stroke. 2018;13:648–653. doi: 10.1177/1747493018765228. - DOI - PubMed

Publication types

Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions

Grants and funding

GNT1079542/Australian National Health and Medical Research Council

LinkOut - more resources

Full Text Sources
- MDPI
- PubMed Central
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical