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An early botulinum toxin A treatment in subacute stroke patients may prevent a disabling finger flexor stiffness six months later: a randomized controlled trial.

Abstract

OBJECTIVE
The study asked whether an early botulinum toxin A (BTX-A) injection in subacute stroke patients may prevent a disabling finger flexor stiffness six months later.
DESIGN
Single-blind, randomized pilot study. Setting: Inpatient rehabilitation centre.
SUBJECTS
Eighteen stroke patients, interval 4-6 weeks, non-functional arm, Fugl-Meyer arm score (0-66) <20, beginning elevated finger flexor tone, randomly allocated to group A or B. Interventions: In group A patients 150 units BTX-A (Xeomin) injected into the deep and superficial finger (100 units) and wrist flexors (50 units), no injection in group B patients. Comprehensive rehabilitation in both groups.
MAIN MEASURES
Primary variable was the Modified Ashworth Scale score (0-5) of the finger flexors; secondary variables were whole arm muscle tone with REPAS (a summary rating scale for resistance to passive movement), its motor control with the Fugl-Meyer arm score, and a disability scale, blindly assessed at T0 (start), T1 (four weeks) and T6 (six months).
RESULTS
Homogeneous groups at T0. Significantly less finger flexor stiffness in the BTX-A group at T1 and T6, the mean (SD) Modified Ashworth Scale scores in group A (B) were: 1.7 ± 0.5 (1.6 ± 0.5) at T0; 0.4 ± 0.5 (1.9 ± 0.7) at T1; and 1.4 ± 0.7 (2.4 ± 0.9) at T6. Among the secondary measures, the disability score, namely the items pain and passive nail trimming, was lower in group A at T1 and T6.
CONCLUSIONS
The results indicate an effect of early BTX-A injection on finger flexor stiffness six months later, presumably attributable to a reduced contracture development. Effect size calculation suggests inclusion of at least 17 patients per group excluding drop-outs in a warranted placebo-controlled trial.

Links

  • Publisher Full Text
  • Authors

    Hesse S, Mach H, Fröhlich S, Behrend S, Werner C, Melzer I

    Source

    Clinical rehabilitation 26:3 2012 Mar pg 237-45

    MeSH

    Adult
    Aged
    Botulinum Toxins, Type A
    Confidence Intervals
    Contracture
    Disability Evaluation
    Drug Administration Schedule
    Female
    Finger Joint
    Follow-Up Studies
    Germany
    Hemiplegia
    Humans
    Injections, Intralesional
    Male
    Middle Aged
    Muscle Spasticity
    Muscle, Skeletal
    Pilot Projects
    Rehabilitation Centers
    Risk Assessment
    Single-Blind Method
    Statistics, Nonparametric
    Stroke
    Time Factors
    Treatment Outcome

    Pub Type(s)

    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21971750