Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport) for the relief of upper back myofascial pain syndrome: results from a randomized double-blind placebo-controlled multicentre study.
Botulinum type A toxin (BoNT-A) has antinociceptive and muscle-relaxant properties and may help relieve the symptoms of myofascial pain syndrome. In this study we evaluated the efficacy and tolerability of BoNT-A (Dysport) in patients with myofascial pain syndrome of the upper back. We conducted a prospective, randomized, double-blind, placebo-controlled, 12-week, multicentre study. Patients with moderate-to-severe myofascial pain syndrome affecting cervical and/or shoulder muscles (10 trigger points, disease duration 6-24 months) were randomized to Dysport or saline. Injections were made into the 10 most tender trigger points (40 units per site). The primary outcome was the proportion of patients with mild or no pain at week 5. Secondary outcomes included changes in pain intensity and the number of pain-free days per week. Tolerability and safety were also assessed. At week 5, significantly more patients in the Dysport group reported mild or no pain (51%), compared with the patients in the placebo group (26%; p=0.002). Compared with placebo, Dysport resulted in a significantly greater change from baseline in pain intensity during weeks 5-8 (p<0.05), and significantly fewer days per week without pain between weeks 5 and 12 (p=0.036). Treatment was well tolerated, with most side effects resolving within 8 weeks. In conclusion, in patients with upper back myofascial pain syndrome, injections of 400 Ipsen units of Dysport at 10 individualised trigger points significantly improved pain levels 4-6 weeks after treatment. Injections were well tolerated.
Göbel
Hartmut
H
Kiel Pain Centre, Heikendorfer Weg 9-27, 24149 Kiel, Germany. hg@schmerzklinik.de
Heinze
Axel
A
Reichel
Gerhard
G
Hefter
Harald
H
Benecke
Reiner
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D001317:Austria; D001416:Back Pain / Q000175:diagnosis / Q000188:drug therapy*; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009209:Myofascial Pain Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects; D010147:Pain Measurement / Q000187:drug effects*; D015990:Placebo Effect; D020069:Shoulder Pain / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A