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

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.

RCT Entities:   Population Interventions Outcomes