OBJECTIVE: To determine if botulinum toxin type B (MyoBloc) decreases spasticity. DESIGN: Investigator-initiated trial, open-label, single-treatment session. SETTING: Single site. PARTICIPANTS: Ten patients with stable upper-limb spasticity and an Ashworth Scale score of 2 or higher at the elbow, wrist, and fingers. INTERVENTIONS: Total dose of 10,000U of botulinum toxin type B injected into 5 major muscles. MAIN OUTCOME MEASURES: The Ashworth Scale, goniometry, and functional assessments were performed at injection and weeks 4, 8, and 12. The principal investigator (PI) global assessment of change (GAC) and the patient GAC were done at weeks 4, 8, and 12 postinjection. The safety of the procedure was measured by adverse events and vital signs. RESULTS: Improvements in Ashworth Scale scores were observed at weeks 4, 8, and 12 postinjection. At week 4, the mean changes (in Ashworth score) were elbow, -1.0 (P=.016); wrist, -1.7 (P=.004); finger, -1.35 (P=.02); at week 8: elbow, -.83 (P=.016); wrist, -1.00 (P=.016); finger, -.94 (P=.08); and at week 12: elbow, -.61 (P=.07); wrist, -1.00 (P=.016); and finger, -.89 (P=.10). The PI GAC improved at all visits. Nine of the 10 subjects reported dry mouth at week 4, with resolution by week 12. No changes were seen on the functional measures. CONCLUSIONS: Botulinum toxin type B may be useful in treatment of spasticity. Copyright 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation
OBJECTIVE: To determine if botulinum toxin type B (MyoBloc) decreases spasticity. DESIGN: Investigator-initiated trial, open-label, single-treatment session. SETTING: Single site. PARTICIPANTS: Ten patients with stable upper-limb spasticity and an Ashworth Scale score of 2 or higher at the elbow, wrist, and fingers. INTERVENTIONS: Total dose of 10,000U of botulinum toxin type B injected into 5 major muscles. MAIN OUTCOME MEASURES: The Ashworth Scale, goniometry, and functional assessments were performed at injection and weeks 4, 8, and 12. The principal investigator (PI) global assessment of change (GAC) and the patient GAC were done at weeks 4, 8, and 12 postinjection. The safety of the procedure was measured by adverse events and vital signs. RESULTS: Improvements in Ashworth Scale scores were observed at weeks 4, 8, and 12 postinjection. At week 4, the mean changes (in Ashworth score) were elbow, -1.0 (P=.016); wrist, -1.7 (P=.004); finger, -1.35 (P=.02); at week 8: elbow, -.83 (P=.016); wrist, -1.00 (P=.016); finger, -.94 (P=.08); and at week 12: elbow, -.61 (P=.07); wrist, -1.00 (P=.016); and finger, -.89 (P=.10). The PI GAC improved at all visits. Nine of the 10 subjects reported dry mouth at week 4, with resolution by week 12. No changes were seen on the functional measures. CONCLUSIONS: Botulinum toxin type B may be useful in treatment of spasticity. Copyright 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation
Authors: Patrick Hogan; P David Charles; Maureen Wooten Watts; Janice M Massey; Tamara Miller; John Mackowiack Journal: Curr Ther Res Clin Exp Date: 2004-03