Open-label, Multicenter, Randomized Study Investigating the Efficacy and Safety of Botulinum Toxin Type A in the Treatment of Myofascial Pain Syndrome in the Neck and Shoulder Girdle

Abstract

Objectives

To evaluate two doses of botulinum toxin A [BoNT-A] for the treatment of chronic myofascial pain syndrome [MPS].

Methods

A 12-week, open-label, randomized study in which patients [N  =  163] with MPS in the neck and shoulder girdle muscles were treated with intramuscular injections of 200 U [25 U/trigger point [TrP]] or 320 U [40 U/TrP] BoNT-A.

Results

At Week 7, 34.8 percent of BoNT-A 200 U and 34.3 percent of BoNT-A 320 U patients had clinically significant improvement in pain. Treatment was well-tolerated.

Conclusions

Both doses provided effective relief from chronic MPS; benefits were maintained for at least three months.

Keywords:

• Botulinum toxin A
• chronic myofascial pain
• safety
• efficacy

ACKNOWLEDGMENTS

This study was supported by Ipsen Pharma GmbH, Germany. Data management and statistical analyses were performed by CRS-Mannheim GmbH, Germany. Editorial assistance for the preparation of this manuscript was provided by Ogilvy Healthworld Medical Education; funding was provided by Ipsen Pharma GmbH. Jörg Jerosch declares no conflict of interest and Manfred Söhling is Speaker honoraria from Ipsen Pharma. The authors thank Dr Helmut Brunner, who was president of the IGOST at that time, for his support in the planning and execution of the study [IGOST: Interdisziplinäre Gesellschaft für Orthopädische und Unfallchirurgische SchmerzTherapie; Interdisciplinary Association for Orthopaedic and Casualty Surgeon Pain Therapy].

Notes

*Dysport is not approved for treatment of myofascial pain