ABSTRACT
Botulinum toxin type A is approved for the focal treatment of spasticity; however, the effectiveness of abobotulinumtoxinA (aboBoNT-A) in patients with shoulder pain who have set reduced pain as a treatment goal is understudied. In addition, some patients encounter delays in accessing treatment programs; therefore, the suitability of aboBoNT-A for pain reduction in this population requires investigation. These factors were assessed in aboBoNT-A-naive Brazilian patients in a post hoc analysis of data from BCause, an observational, multicenter, prospective study (NCT02390206). Patients (N = 49, n = 25 female; mean (standard deviation) age of 60.3 (9.1) years; median (range) time since onset of spasticity of 16.1 (0-193) months) received aboBoNT-A injections to shoulder muscles in one or two treatment cycles (n = 47). Using goal attainment scaling (GAS), most patients achieved their goal of shoulder pain reduction after one treatment cycle (72.1%; 95% confidence interval: 57.2-83.4%). Improvements in GAS T-score from baseline, clinically meaningful reductions in pain score at movement, and clinically meaningful increases in passive shoulder abduction angle further improved with repeated treatment more than 4 months later, despite treatment starting at a median of 16.1 months after the onset of spasticity. These findings support the further investigation of aboBoNT-A injections in chronic post-stroke shoulder pain.
Subject(s)
Botulinum Toxins, Type A , Shoulder , Aged , Female , Humans , Male , Middle Aged , Botulinum Toxins, Type A/therapeutic use , Muscle Spasticity/drug therapy , Muscle Spasticity/etiology , Prospective Studies , Shoulder Pain/drug therapy , Shoulder Pain/etiologyABSTRACT
Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.
