A 56-year-old man became quadriplegic, bed bound, and carer-dependent secondary to cervical osteomyelitis. Three years later, he presented with generalised spasticity, crouched posture, and a large sacral pressure sore. The severe spasticity in his hips and knees prevented ischial sitting. Injections of botulinum toxin type A to both hamstrings and gastrosoleuii controlled the flexor spasticity of his lower limbs and facilitated rehabilitation and wound healing through proper positioning, wound care, stretching, and weight-bearing exercises. A few weeks later, the patient could better position himself in bed (prone lying) and on his wheelchair (ischial sitting). His spasm-related pain lessened and his mobility and activities of daily living improved. The sacral pressure sore healed completely a few months later. The patient could sleep better, feed with set-up and adaptive aids, groom, dress, and transfer himself with minimal assistance. The effects of botulinum toxin extended beyond just spasticity reduction. His upper extremity function, mobility, and social well-being were all improved through better positioning.
The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2⁻12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies.