Jump to ContentJump to Main Navigation
Show Summary Details
More options …

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

Online
ISSN
1877-8879
See all formats and pricing
More options …
Volume 2, Issue 1

Issues

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
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ 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
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2011-01-01 | DOI: https://doi.org/10.1016/j.sjpain.2010.11.002

Abstract

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.

Methods

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.

Results

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.

Conclusions

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.

Implications

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.

References

  • [1]

    FischerAA. New developments in diagnosis of myofascial pain and fibromyalgia. Phys Med Rehabil Clin NorthAm 1997;8:1–22.CrossrefGoogle Scholar

  • [2]

    Gerwin RD. Classification, epidemiology, and natural history of myofascial pain syndrome. Curr Pain Headache Rep 2001;5:412–20.CrossrefPubMedGoogle Scholar

  • [3]

    Wheeler AH. Myofascial pain disorders: theory to therapy. Drugs 2004;64:45–62.PubMedCrossrefGoogle Scholar

  • [4]

    Simons DG. Clinical and etiological update of myofascial pain from trigger points. J Musculoskeletal Pain 1996;4:93–121.CrossrefGoogle Scholar

  • [5]

    KuanTS. Current studies on myofascial painsyndrome. Curr Pain Headache Rep 2009;13:365–9.CrossrefGoogle Scholar

  • [6]

    Baldry P. Management of myofascial trigger point pain. Acupunct Med 2002;20:2–10.PubMedCrossrefGoogle Scholar

  • [7]

    Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep 2006;10:345–9.PubMedCrossrefWeb of ScienceGoogle Scholar

  • [8]

    Rudin NJ. Evaluation of treatments for myofascial pain syndrome and fibromyalgia. Curr Pain Headache Rep 2003;7:433–42.CrossrefPubMedGoogle Scholar

  • [9]

    Casale R, Tugnoli V. Botulinum toxin for pain. Drugs R D 2008;9:11–27.PubMedCrossrefWeb of ScienceGoogle Scholar

  • [10]

    Jeynes LC, Gauci CA. Evidence forthe use ofbotulinum toxin inthe chronic pain setting - a review ofthe literature. Pain Pract 2008;8:269–76.CrossrefGoogle Scholar

  • [11]

    Qerama E, Fuglsang-Frederiksen A, Jensen TS. The role ofbotulinum toxin in management of pain: an evidence-based review. Curr Opin Anaesthesiol 2010;23:602–10.CrossrefGoogle Scholar

  • [12]

    Filippi GM, Errico P, Santarelli R, Bagolini B, Manni E. BotulinumAtoxin effects on rat jaw muscle spindles. Acta Otolaryngol 1993;113:400–4.PubMedCrossrefGoogle Scholar

  • [13]

    Rosales RL, Arimura K, Takenaga S, Osame M. Extrafusal and intrafusal muscle effects in experimental botulinum toxin-A injection. Muscle Nerve 1996;19:488–96.CrossrefPubMedGoogle Scholar

  • [14]

    Acquadro MA, Borodic GE. Botulinum toxin efficacy forthe treatment of pain. J Clin Anesth 2005;17:328–30.CrossrefGoogle Scholar

  • [15]

    Cheshire WP, Abashian SW, Mann JD. Botulinum toxin in the treatment of myofascial pain syndrome. Pain 1994;59:65–9.CrossrefPubMedGoogle Scholar

  • [16]

    Ferrante FM, Bearn L, Rothrock R, King L. Evidence againsttriggerpoint injection technique for the treatment ofcervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology 2005;103:377–83.PubMedCrossrefGoogle Scholar

  • [17]

    Göbel H, Heinze A, Reichel G, Hefter H, Benecke R. Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport) for the relief of upperback myofascial pain syndrome: results from a randomized double-blind placebo-controlled multicentre study. Pain 2006;125:82–8.CrossrefGoogle Scholar

  • [18]

    Graboski CL, Gray DS, Burnham RS. Botulinum toxin A versus bupivacaine trigger point injections for the treatment of myofascial pain syndrome: a randomised double blind crossover study. Pain 2005;118:170–5.CrossrefPubMedGoogle Scholar

  • [19]

    Ho KY, Tan KH. Botulinum toxin A for myofascial trigger point injection: a qualitative systematic review. Eur J Pain 2007;11:519–27.Web of ScienceCrossrefPubMedGoogle Scholar

  • [20]

    Kamanli A, Kaya A, Ardicoglu O, Ozgocmen S, Zengin FO, Bayik Y. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Rheumatol Int 2005;25:604–11.PubMedCrossrefGoogle Scholar

  • [21]

    Ojala T, Arokoski JP, Partanen J. The effect of small doses of botulinum toxin A on neck-shoulder myofascial pain syndrome: a double-blind, randomized, and controlled crossover trial. Clin J Pain 2006;22:90–6.PubMedCrossrefGoogle Scholar

  • [22]

    Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain 2000;85:101–5.CrossrefPubMedGoogle Scholar

  • [23]

    Qerama E, Fuglsang-Frederiksen A, Kasch H, Bach FW, Jensen TS. A double-blind, controlled study of botulinum toxin A in chronic myofascial pain. Neurology 2006;67:241–5.CrossrefPubMedWeb of ScienceGoogle Scholar

  • [24]

    Wheeler AH, Goolkasian P, Gretz SS. A randomized, double-blind, prospective pilot study of botulinum toxin injection for refractory, unilateral, cervicothoracic, paraspinal, myofascial pain syndrome. Spine (Phila Pa 1976) 1998;23:1662–6, discussion 7.CrossrefPubMedGoogle Scholar

  • [25]

    Yue SK. Initial experience in the use of botulinum-toxin A for the treatment of myofascial related muscle dysfunctions .J Musculoskelet Pain 1995;3:22.Google Scholar

  • [26]

    Bakheit AM, Fedorova NV, Skoromets AA, Timerbaeva SL, Bhakta BB, Coxon L. The beneficial antispasticity effect of botulinum toxin type A is maintained after repeated treatment cycles.J Neurol Neurosurg Psychiatry 2004;75:1558–61.PubMedCrossrefGoogle Scholar

  • [27]

    Hyman N, Barnes M, Bhakta B, Cozens A, Bakheit M, Kreczy-Kleedorfer B, et al. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomised, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry 2000;68:707–12.PubMedCrossrefGoogle Scholar

  • [28]

    Jitpimolmard S, Tiamkao S, Laopaiboon M. Long term results of botulinum toxin type A (Dysport) in the treatment of hemifacial spasm: a report of 175 cases. J Neurol Neurosurg Psychiatry 1998;64:751–7.CrossrefPubMedGoogle Scholar

  • [29]

    Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, et al. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformityafter stroke. Cerebrovasc Dis 2003;15:289–300.PubMedCrossrefGoogle Scholar

  • [30]

    Truong D, Duane DD, Jankovic J, Singer C, Seeberger LC, Comella CL, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord 2005;20:783–91.CrossrefPubMedGoogle Scholar

  • [31]

    Truong D, Comella C, Fernandez HH, Ondo WG. Dysport Benign Essential Blepharospasm Study Group. Parkinsonism Relat Disord 2008;14:407–14.PubMedGoogle Scholar

  • [32]

    Van den Bergh P, Francart J, Mourin S, Kollmann P, Laterre EC. Five-year experience in the treatment of focal movement disorders with low-dose Dysport botulinum toxin. Muscle Nerve 1995;18:720–9.PubMedCrossrefGoogle Scholar

  • [33]

    Wissel J, Kanovsky P, Ruzicka E, Bares M, Hortova H, Streitova H, et al. Efficacy and safety of a standardised 500 unit dose of Dysport (clostridium botulinum toxin type A haemaglutinin complex) in a heterogeneous cervical dystonia population: results of a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel group study. J Neurol 2001;248:1073–8.Google Scholar

  • [34]

    Chibnall JT, Tait RC. The Pain Disability Index: factor structure and normative data. Arch Phys Med Rehabil 1994;75:1082–6.CrossrefPubMedGoogle Scholar

  • [35]

    Pollard CA. The relationship of family environment to chronic pain disability. Diss Abstr Int 1981:42 (2077B).Google Scholar

  • [36]

    Tait RC, Pollard CA, Margolis RB, Duckro PN, Krause SJ. The Pain Disability Index: psychometric and validity data. Arch Phys Med Rehabil 1987;68: 438–41.PubMedGoogle Scholar

  • [37]

    Fischer AA. Pressure threshold meter: its use for quantification of tender spots. Arch Phys Med Rehabil 1986;67:836–8.PubMedGoogle Scholar

  • [38]

    Fischer AA. Pressure tolerance over muscles and bones in normal subjects. Arch Phys Med Rehabil 1986;67:406–9.PubMedGoogle Scholar

  • [39]

    Fischer AA. Tissue compliance meter for objective, quantitative documentation of soft tissue consistency and pathology. Arch Phys Med Rehabil 1987;68:122–5.PubMedGoogle Scholar

  • [40]

    Colditz GA, Miller JN, Mosteller F. Measuring gain in the evaluation of medical technology. The probability of a better outcome. Int J Technol Assess Health Care 1988;4:637–42.CrossrefPubMedGoogle Scholar

  • [41]

    Wei L, Lachin J. Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J Am Stat Assoc 1984;79:653–61.CrossrefGoogle Scholar

  • [42]

    Grosse J, Kramer G, Stohrer M. Success of repeat detrusor injections of botulinum A toxin in patients with severe neurogenic detrusor overactivity and incontinence. Eur Urol 2005;47:653–9.CrossrefPubMedGoogle Scholar

  • [43]

    Rosales RL, Bigalke H, Dressler D. Pharmacology of botulinum toxin: differences between type A preparations. Eur J Neurol 2006;13(Suppl. 1):2–10.PubMedCrossrefGoogle Scholar

  • [44]

    Straughan D. Progress in applying the three Rs to the potency testing of botulinum toxin type A. Altern Lab Anim 2006;34:305–13.PubMedGoogle Scholar

  • [45]

    Van den Bergh PY, Lison DF. Dose standardization of botulinum toxin. Adv Neurol 1998;78:231–5.PubMedGoogle Scholar

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.

Export Citation

© 2010 Scandinavian Association for the Study of Pain.Get Permission

Comments (0)

Please log in or register to comment.
Log in