Objective: We aimed to evaluate the efficacy and safety of injecting botulinum toxin A (BoNT-A)
into the neck muscles to treat cervical dystonia (CD) in patients with dyskinetic cerebral palsy
(CP).
Method: This was a randomized, double-blinded, placebo-controlled trial with cross-over design. We
prospectively enrolled adults with dyskinetic CP who were over 20 years old and had been clinically
diagnosed with CD for more than one year. The primary outcome measure was the change in Toronto
Western Spasmodic Torticollis Rating Scale (TWSTRS) at four weeks from the baseline TWSTRS.
Results: Seventeen patients were initially enrolled, but one patient was excluded after the final evaluation
because of a violation of the study protocol. Demographic and clinical data for the sixteen participants
included in the study are presented in Table 1.
- Changes on the TWSTRS after the Injection
TWSTRS total scores at baseline, four weeks, and 12 weeks are presented in Figure 1. At four weeks, the BoNT-A injections showed significant improvement in the TWSTRS total score (Figure 1A) compared to the saline injections (p = 0.0286 for ANCOVA). At 12 weeks, the BoNT-A injections had a tendency to show greater improvement than the saline injections, but this difference was not statistically significant (p = 0.0783). There was no significant difference between the two injections on the TWSTRS severity score (Figure 1B). At four weeks there was a significant improvement in the TWSTRS disability score (Figure 1C) for the BoNT-A injections compared to the saline injections (p = 0.0152), but there was no significant difference after 12 weeks (p = 0.6444). On the TWSTRS pain score (Figure 1D), the BoNT-A injections showed statistically significant improvement compared to the saline injections at both four and 12 weeks (p = 0.0013 and 0.0200, respectively).
- Changes in Numerical Rating Scale (NRS) after the Injection
Figure 2 presents the NRS for both pain and disability at baseline, four weeks, and 12 weeks and the NRS for satisfaction at four weeks and 12 weeks. On the pain NRS (Figure 2A), the BoNT-A injections had a tendency toward lower pain at four and 12 weeks, but there was no statistically significant difference between the two treatments (p = 0.0603 and 0.1796, respectively). On the disability NRS (Figure 2B), the BoNT-A injections had a tendency toward lower disability at four weeks, but there was no statistically significant difference between the two treatments (p = 0.1466). On the satisfaction NRS (Figure 2C), which was not obtained at the baseline, the BoNT-A injections scored higher at four weeks and 12 weeks. This difference reached statistical significance only at four weeks (p = 0.0176).
Conclusion: BoNT-A injection for CD in adults with dyskinetic CP is relative safe and improves pain and disability. |
