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  • Phase I/II parallel double-blind randomized controlled clinical trial of perispinal etanercept for chronic stroke

    Author(s)
    Ralph, Stephen
    Ferguson, Samantha
    Griffith University Author(s)
    Ralph, Stephen J.
    Ferguson, Samantha
    Year published
    2020-01
    Metadata
    Show full item record
    Abstract
    Background: Previous open-label studies showed that chronic post-stroke pain could be abated by treatment with perispinal etanercept, although these benefits were questioned. A randomized double-blind placebo controlled clinical trial was conducted to test perispinal etanercept for chronic post-stroke pain. Research design and methods: Participants received two treatments, either perispinal etanercept (active) or saline (control). Primary outcomes were the differences in daily pain levels between groups analyzed by SPSS. Results: On the 0–100 points visual analog scale, perispinal etanercept reduced mean levels for ...
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    Background: Previous open-label studies showed that chronic post-stroke pain could be abated by treatment with perispinal etanercept, although these benefits were questioned. A randomized double-blind placebo controlled clinical trial was conducted to test perispinal etanercept for chronic post-stroke pain. Research design and methods: Participants received two treatments, either perispinal etanercept (active) or saline (control). Primary outcomes were the differences in daily pain levels between groups analyzed by SPSS. Results: On the 0–100 points visual analog scale, perispinal etanercept reduced mean levels for worst and average daily pain from baseline after two treatments by 19.5 – 24 points (p < 0.05), and pain alleviation was maintained in the etanercept group, with no significant change in the control group. Thirty percent of etanercept participants had near complete pain abatement after first treatment. Goniometry of the paretic arm showed improved mean shoulder rotation by 55 degrees in active forward flexion for the etanercept group (p = 0.003) only. Conclusions: Perispinal etanercept can provide significant and ongoing benefits for the chronic poststroke management of pain and greater shoulder flexion by the paretic arm. Effects are rapid and highly significant, supporting direct action on brain function. Trial registration: ACTRN12615001377527 and Universal Trial Number U1111-1174-3242.
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    Publisher URI
    https://griffith.edu.au/
    DOI
    https://doi.org/10.25904/5e1bea4668c34
    Copyright Statement
    Restricted access and viewing. Investigators must request access for citation or collaboration after completing agreement. No restrictions for how people with access can reuse the data following approved access. Requests via mediated request form.
    Item Access Status
    Mediated access requests via link provided.
    Note
    Dataset supporting publication: Phase I/II parallel double-blind randomized controlled clinical trial of perispinal etanercept for chronic stroke: improved mobility and pain alleviation. Ralph SJ, Weissenberger A, Bonev V, King LD, Bonham MD, Ferguson S, Smith AD, Goodman-Jones AA, Espinet AJ. Expert Opin Investig Drugs. 2020 Jan 3:1-16. doi: 10.1080/13543784.2020.1709822. [Epub ahead of print] PMID: 31899977
    Subject
    Central Nervous System
    Neurology and Neuromuscular Diseases
    Clinical trial
    perispinal etanercept
    reduced post-stroke pain
    increased flexion
    Publication URI
    http://hdl.handle.net/10072/390154
    Data link
    https://bit.ly/GRDCmediation
    Collection
    • Research data

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