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Botulinum toxin type A (BTX-A) is the treatment of choice for hemifacial spasm (HFS) with a transient effect of around 3 to 4 months. Its efficacy might be enhanced by active muscle exercise immediately after an injection. Enhanced neuromuscular junction blocking effect of BTX-A in patients with writer’s cramp and spasmodic dysphonia was demonstrated.1 2 One small randomised controlled trial (RCT) of combined facial exercise and BTX-A in patients with abnormal facial movements reported no significant reduction in the severity and frequency of facial muscle spasm.3 However, only four patients with HFS were included.
Thus, we conducted a pilot, randomised, cross-over trial to explore the efficacy and safety of the combined facial exercise with BTX-A injection versus BTX-A injection along with the feasibility for a future confirmatory trial.
Methods and patients
A 32-week, pilot, assessor-blinded, single-centred, randomised, controlled AB/BA cross-over design of combined facial exercise with BTX-A injection (treatment A) versus BTX-A injection alone (treatment B) in adult patients with HFS was performed.
Participants aged 18–80 years with HFS of any degree of severity treated regularly with BTX-A every 16 weeks were recruited. Exclusion criteria were stroke, blepharospasm, dementia, blindness, physical dependence, taking anticoagulants and inability to perform the facial exercise following video guidance.
Eligible participants were randomised to combined facial exercise with BTX-A injection, followed by BTX-A injection only (Group AB) or vice versa (Group BA). Both groups were injected with onabotulinumtoxinA (Botox; Allergan, Irvine, California, USA). In brief, the novel protocol involved 7 min of active and passive facial muscle squeezing of the muscles usually affected by …
Contributors YP and PS conceptualised and wrote the study protocol, performed the study, collected the data, and prepared the first draft and revised the manuscript. AS, JS and TS helped to perform the study, collected the data, reviewed and criticised this manuscript. CK served as a statistical consultant, selected the statistical analysis method and performed these analyses. PS conceptualised the study protocol, performed the study, criticised and revised the manuscript for intellectual content.
Funding This study was funded by the Siriraj Medical Research Center (grant no: Si 080/2018).
Competing interests None declared.
Patient consent for publication Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
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