Clinical benefit of botulinum toxin for treatment of persistent TMD‐related myofascial pain: A randomized, placebo‐controlled, cross‐over trial.
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| Title: | Clinical benefit of botulinum toxin for treatment of persistent TMD‐related myofascial pain: A randomized, placebo‐controlled, cross‐over trial. |
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| Authors: | Sitnikova, V., Kämppi, A., Kämppi, L., Alvesalo, E., Burakova, M., Kemppainen, P., Teronen, O. |
| Source: | Pain Practice. Nov2024, Vol. 24 Issue 8, p1014-1023. 10p. |
| Subjects: | Temporomandibular disorders, Pain measurement, Placebos, Physiologic salines, Statistical sampling, Randomized controlled trials, Treatment effectiveness, Mann Whitney U Test, Descriptive statistics, Crossover trials, Injections, Electromyography, Masticatory muscles, Dental occlusion, Botulinum toxin, Drug efficacy, Comparative studies, Sociodemographic factors, Data analysis software, Algorithms |
| Abstract: | Background: Injections of botulinum toxin type A (BoNT‐A) have been proposed as an additional treatment modality for patients suffering chronic temporomandibular disorder (TMD)‐related myofascial pain (MFP). BoNT‐A impairs muscle function, along with its analgesic effect, and a minimal effective dose should be used. The objective of this randomized placebo‐controlled crossover study was to evaluate the clinical benefit of a moderate dose (50 U) of BoNT‐A. Methods: Sixty‐six subjects were randomized into two groups, one which received BoNT‐A first and a second which received a saline solution (SS) first. Follow‐ups were performed 2, 11, and 16 weeks after the injections. Diagnostic criteria for temporomandibular disorders (DC/TMD) diagnostic algorithms were used to evaluate characteristic pain intensity (CPI) and pain‐related disability based on the Graded Chronic Pain Scale (GCPS). Electromyographic and bite force were also evaluated. Results: The within‐group analysis showed a significant improvement in pain intensity and pain‐related disability after BoNT‐A (p < 0.001, p = 0.005, p = 0.011) and SS (p = 0.003, p = 0.005, p = 0.046) injections up to week 16. The between‐group analysis of pain‐related variables revealed no differences between groups at any time. Nonetheless, BoNT‐A, but not SS, caused a significant decline in muscle performance. The number needed to treat (NNT) regarding a clinically significant pain reduction (≥30%) was 6.3, 57.0, and 19.0 at 2, 11, and 16‐week follow‐ups favoring BoNT‐A. Conclusions: Injections of 50 U of BoNT‐A might improve MFP symptoms, but the specific effect of the drug on pain compared to the placebo is not obvious. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| Abstract: | Background: Injections of botulinum toxin type A (BoNT‐A) have been proposed as an additional treatment modality for patients suffering chronic temporomandibular disorder (TMD)‐related myofascial pain (MFP). BoNT‐A impairs muscle function, along with its analgesic effect, and a minimal effective dose should be used. The objective of this randomized placebo‐controlled crossover study was to evaluate the clinical benefit of a moderate dose (50 U) of BoNT‐A. Methods: Sixty‐six subjects were randomized into two groups, one which received BoNT‐A first and a second which received a saline solution (SS) first. Follow‐ups were performed 2, 11, and 16 weeks after the injections. Diagnostic criteria for temporomandibular disorders (DC/TMD) diagnostic algorithms were used to evaluate characteristic pain intensity (CPI) and pain‐related disability based on the Graded Chronic Pain Scale (GCPS). Electromyographic and bite force were also evaluated. Results: The within‐group analysis showed a significant improvement in pain intensity and pain‐related disability after BoNT‐A (p < 0.001, p = 0.005, p = 0.011) and SS (p = 0.003, p = 0.005, p = 0.046) injections up to week 16. The between‐group analysis of pain‐related variables revealed no differences between groups at any time. Nonetheless, BoNT‐A, but not SS, caused a significant decline in muscle performance. The number needed to treat (NNT) regarding a clinically significant pain reduction (≥30%) was 6.3, 57.0, and 19.0 at 2, 11, and 16‐week follow‐ups favoring BoNT‐A. Conclusions: Injections of 50 U of BoNT‐A might improve MFP symptoms, but the specific effect of the drug on pain compared to the placebo is not obvious. [ABSTRACT FROM AUTHOR] |
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| ISSN: | 15307085 |
| DOI: | 10.1111/papr.13396 |
