Randomized Controlled Trial Multicenter Study Comparative Study
- Malin Ernberg, Britt Hedenberg-Magnusson, Thomas List, and Peter Svensson.
- Unit of Clinical Oral Physiology, Department of Dental Medicine, Karolinska Institutet, Box 4064, SE 141 04 Huddinge, Sweden Department of Stomatognathic Physiology, Eastman Institute, Dalagatan 11, SE 113 24 Stockholm, Sweden Department of Stomatognathic Physiology, Faculty of Dentistry, Malmö University, SE 212 22 Malmö, Sweden Department of Clinical Oral Physiology, School of Dentistry, Aarhus University, DK 8000 Aarhus, Denmark Center for Functionally Integrative Neuroscience (CFIN), MindLab, Aarhus University Hospital, Aarhus, Denmark.
- Pain. 2011 Sep 1; 152 (9): 1988-1996.
AbstractEvidence of an effect by botulinum toxins is still lacking for most pain conditions. In the present randomized, placebo-controlled, crossover multicenter study, the efficacy of botulinum toxin type A (BTX-A) was investigated in patients with persistent myofascial temporomandibular disorders (TMD). Twenty-one patients with myofascial TMD without adequate pain relief after conventional treatment participated. A total of 50 U of BTX-A or isotonic saline (control) was randomly injected into 3 standardized sites of the painful masseter muscles. Follow-up was performed after 1 and 3 months, followed by a 1-month washout period, after which crossover occurred. Pain intensity at rest was the primary outcome measure, while physical and emotional function, global improvement, side effects, and clinical measures were additional outcome measures. There was no main difference between drugs (ANOVA; P=.163), but there was a significant time effect (P<.001), so BTX-A reduced mean (SD) percent change of pain intensity by 30 (33%) after 1 month and by 23 (30%) after 3 months compared to 11 (40%) and 4 (33%) for saline. The number of patients who received a 30% pain reduction was not significantly larger for BTX-A than after saline at any follow-up visit. The number needed to treat was 11 after 1 month and 7 after 3 months. There were no significant changes after treatment in any other outcome measures, with the exception of pain on palpation, which decreased 3 months after saline injection (P<.05). These results do not indicate a clinical relevant effect of BTX-A in patients with persistent myofascial TMD pain.Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
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