OBJECTIVE: To determine whether additional physiotherapy increases Botulinum toxin type A effects in reducing spasticity in patients with multiple sclerosis. DESIGN: A single-blind, randomized, controlled pilot trial with a 12-week study period. SUBJECTS: Thirty-eight patients with progressive multiple sclerosis affected by focal spasticity and who were observed at the Multiple Sclerosis Centre operating in the S Andrea Hospital in Rome. INTERVENTIONS: For intervention all patients received Botulinum toxin type A; the treatment group also received additional physiotherapy to optimize management through passive or active exercise and stretching regimens. MAIN MEASURES: To measure objective and subjective level of spasticity, patients were assessed at baseline, 2, 4 and 12 weeks post treatment by Modified Ashworth Scale and visual analogue scale. RESULTS: When compared with the control group, we found a significant decrease of spasticity by Modified Ashworth Scale (p < 0.01 by t-test) in the treatment group at week 2 (2.73 versus 3.22), week 4 (2.64 versus 3.33) and week 12 (2.68 versus 3.33). The mean (%) difference in Modified Ashworth Scale score between baseline and the end of follow-up was -0.95 (26.1) in the treatment group and -0.28 (7.7) in the control group (p < 0.01). The combined treatment proved also to be more effective by visual analogue scale (p < 0.01) at week 4 (6.95 versus 5.50) and at week 12 (7.86 versus 6.56) but not at week 2 (5.18 versus 5.50; p = 0.41). CONCLUSIONS: Our data suggest that physiotherapy in combination with Botulinum toxin type A injection can improve overall response to Botulinum toxin.

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