Botulinum Type A Toxin Complex for the Relief of Upper Back Myofascial Pain Syndrome: How Do Fixed-Location Injections Compare with Trigger Point-Focused Injections?

Objective.  This was a prospective, randomized, double‐blind, placebo‐controlled, 12‐week, multicenter study to evaluate the efficacy and tolerability of fixed location injections of botulinum type A toxin (BoNT‐A, Dysport) in predetermined injection sites in patients with myofascial pain syndrome o...

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Bibliographic Details
Published in:Pain medicine (Malden, Mass.) Mass.), 2011-11, Vol.12 (11), p.1607-1614
Main Authors: Benecke, Reiner, Heinze, Axel, Reichel, Gerhard, Hefter, Harald, Göbel, Hartmut
Format: Article
Language:English
Subjects:
Adult
Back Pain - drug therapy
Botulinum Toxins, Type A - administration & dosage
Botulinum Toxins, Type A - therapeutic use
Botulinum Type A Toxin
Cervical Vertebrae
Double-Blind Method
Drug therapy
Humans
Injection Technique
Injections
Male
Middle Aged
Muscles
Myofascial Pain Syndromes - drug therapy
Myofascial Trigger Points
Neuromuscular Agents - administration & dosage
Neuromuscular Agents - therapeutic use
Pain
Pain Measurement
Placebos
Prospective Studies
Shoulder
Treatment Outcome
Trigger Points
Upper Back Myofascial Pain
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Summary:Objective.  This was a prospective, randomized, double‐blind, placebo‐controlled, 12‐week, multicenter study to evaluate the efficacy and tolerability of fixed location injections of botulinum type A toxin (BoNT‐A, Dysport) in predetermined injection sites in patients with myofascial pain syndrome of the upper back. Design.  Patients with moderate‐to‐severe myofascial pain syndrome affecting cervical and/or shoulder muscles (10 trigger points, disease duration 6–24 months) and moderate‐to‐severe pain intensity were randomized to BoNT‐A (N = 81) or saline (N = 72). Intervention.  Patients received treatment into 10 predetermined fixed injection sites in the head, neck, and shoulder (40 units of BoNT‐A per site or saline, a total of 400 units of BoNT‐A). Outcome Measures.  The primary efficacy outcome was the proportion of patients with mild or no pain at week 5 (responders). Secondary outcomes included changes in pain intensity and the number of pain‐free days per week. Results.  At week 5, 49% (37/76) of BoNT‐A patients and 38% (27/72) of placebo patients had responded to treatment (P = 0.1873). Duration of daily pain was reduced in the BoNT‐A group compared with the placebo group from week 5, with statistically significant differences at weeks 9 and 10 (P = 0.04 for both). Treatment was well tolerated. Conclusion.  Fixed‐location treatment with BoNT‐A of patients with upper back myofascial pain syndrome did not lead to a significant improvement of the main target parameter in week 5 after treatment. Only in week 8 were significant differences found. Several secondary parameters, such as physicians' global assessment and patients' global assessment, significantly favored BoNT‐A over placebo at weeks 8 and 12.
ISSN:1526-2375
1526-4637
DOI:10.1111/j.1526-4637.2011.01163.x