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Scandinavian Journal of Pain

Official Journal of the Scandinavian Association for the Study of Pain

Editor-in-Chief: Breivik, Harald

CiteScore 2018: 0.85

SCImago Journal Rank (SJR) 2018: 0.494
Source Normalized Impact per Paper (SNIP) 2018: 0.427

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Volume 2, Issue 1


Dysport® for the treatment of myofascial back pain: Results from an open-label, Phase II, randomized, multicenter, dose-ranging study

Gerhard H.H. Müller-Schwefe
  • Corresponding author
  • Facharzt für Anasthesiologie und fur Allgemeinmedizin, Spezielle Schmerztherapie, Leitender Arzt Schmerzzentrum Göppingen, Schillerplatz 8/1, D-73033 Göppingen, Germany
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/ Michael A. Überall
  • Institut für Neurowissenschaften, Algesiologie und Pädiatrie (IFNAP), Deutsche Gesellschaft für Schmerztherapie (DGS), O. Meany – Medical Data & Project Management GmbH, Theodorstraße 1, D-90489 Nürnberg, Germany
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Published Online: 2011-01-01 | DOI: https://doi.org/10.1016/j.sjpain.2010.11.002


Background and purpose

Botulinum toxin type A (BoNT-A) has antinociceptive and muscle-relaxant properties. The objectives of this study were to investigate the efficacy and safety of a single BoNT-A (Dysport®) treatment in myofascial back pain.


In this randomized, open-label, multicenter study, adults with myofascial lower back pain received Dysport® injections at four trigger points (60,80 or 120 units per injection point). Patients were followed for 12 weeks. The a priori primary endpoint was a pooled evaluation, at Week 6, of seven measures of efficacy, including pain intensity (patient diary), modified Pain Disability Index (PDI) score, use of interfering concomitant analgesics, and patient-rated global efficacy. Optional assessments of pressure thresholds and tissue compliance were conducted. Safety was also assessed.


A total of 202 patients were randomized to treatment and 189 patients received a low (n = 57), medium (n = 57), or high (n = 75) total dose of Dysport® at 34 centers in Germany between October 2002 and October 2003. All treated patients were included in the safety population; 8 patients were excluded from the intention-to-treat population. Patients had moderate to severe pain at baseline. At baseline, 120 patients were receiving concomitant analgesic therapy; 6.7%, 74.2% and 19.2% were considered to cause mild, moderate and severe interference with pain measurements, respectively. There was no difference between doses for the a priori combined primary endpoint. Patient-reported pain intensity scores at rest and on movement decreased significantly after treatment for all groups combined (p < 0.0001 at all visits). At Week 6, reductions in pain intensity at rest were 29%, 19% and 26% for the low-, medium- and high-dose groups, respectively; reductions in pain intensity on movement were 27%, 18% and 26%, respectively. Overall, patients who reported pain intensity reductions at Week 6 were evident within 3 weeks of treatment and were maintained for the 12 weeks of the study. In the total population, significant decreases in mean PDI sum scores from baseline were observed from Week 3 and were maintained through to the end of treatment (Week 12); no differences between the dose groups were observed. Pressure thresholds and tissue compliance also increased during the study. Adverse events were generally as expected for BoNT-A; the majority were mild or moderate in severity.


Dysport® treatment was associated with reductions in myofascial back pain and was well tolerated. Nodose-response relationship was observed; treatment with Dysport® using a four-trigger-point injection protocol at 60 units per trigger point was associated with a clinically relevant and statistically significant improvement in pain and pain-related disability; there was no additional benefit from the higher doses.


Our findings are limited by the lack of a control group and further research is warranted to confirm the value of Dysport® for the treatment of myofascial back pain and confirm the optimum dosing in this indication.

Keywords: Myofascial pain syndrome; Myofascial back pain; Botulinum toxin type A; Dysport®

DOI of refers to article: 10.1016/j.sjpain.2010.12.002.


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About the article

Tel.: +49 7161 97 64 76; fax: +49 7161 97 64 77 E-mail: gerhard@mueller-schwefe.de

Received: 2010-08-17

Revised: 2010-10-25

Accepted: 2010-11-08

Published Online: 2011-01-01

Published in Print: 2011-01-01

Conflict of interestConflict of interest statement: The authors have no commercial associations (e.g. consultancies, stock ownership, equity interest, and patent-licensing arrangements) that might pose a conflict of interest in connection with this article.

Citation Information: Scandinavian Journal of Pain, Volume 2, Issue 1, Pages 25–33, ISSN (Online) 1877-8879, ISSN (Print) 1877-8860, DOI: https://doi.org/10.1016/j.sjpain.2010.11.002.

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