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Does giving segmental muscle vibration alter the response to Botulinum toxin injections in the treatment of spasticity in people with multiple sclerosis? A single-blind randomized controlled trial [with consumer summary] |
Paoloni M, Giovannelli M, Mangone M, Leonardi L, Tavernese E, di Pangrazio E, Bernetti A, Santilli V, Pozzilli C |
Clinical Rehabilitation 2013 Sep;27(9):803-812 |
clinical trial |
8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine if segmental muscle vibration and Botulinum toxin-A injection, either alone or in combination, reduces spasticity in a sample of patients with multiple sclerosis. DESIGN: Single-blind, randomized controlled trial. SETTING: Physical medicine and rehabilitation outpatients service. SUBJECTS: Forty-two patients affected by the secondary progressive form of multiple sclerosis randomized to group A (30 minutes of 120 Hz segmental muscle vibration over the rectus femoris and gastrocnemius medial and lateral, three per week, over a period of four weeks), group B (Botulinum toxin in the rectus femoris, gastrocnemius medial and lateral and soleus, and segmental muscle vibration) and group C (botulinum toxin). MAIN MEASURES: Modified Ashworth Scale at knee and ankle, and Fatigue Severity Scale. All the measurements were performed at baseline (T0), 10 weeks (T1) and 22 weeks (T2) postallocation. RESULTS: Modified Ashworth Scale at knee and ankle significantly decreased over time (p < 0.001) in all groups. Patients in group C displayed a significant increase of knee and ankle spasticity at T2 when compared with T1 (p < 0.05). Fatigue Severity Scale values in groups A and C were significantly higher at T0 (A 53.6 (2.31); C 48.5 (2.77)) than at either T1 (A 48.6 (2.21); p = 0.03; C 43.5 (3.22); p = 0.03) or T2 (A 46.7 (2.75); p = 0.02; C 42.5 (2.17); p = 0.02), while no differences were detected in group B (T0 43.4 (3.10); T1 37.3 (3.15); T2 39.7 (2.97)). CONCLUSION: Segmental muscle vibration and Botulinum toxin-A reduces spasticity and improves fatigue in the medium-term follow-up in patients with multiple sclerosis.
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