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A randomised double blind crossover study
Botulinum toxin A versus bupivacaine trigger point injections for the treatment of myofascial pain syndrome: A randomised double blind crossover study Corrie L. Graboski, D. Shaun Gray, Robert S. Burnham Pain Nov;118(1-2): Epub 2005 Oct 3
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Introduction Myofascial pain syndrome (MPS) is characterized by muscle pain, tenderness, fatigue and stiffness. The hallmark physical examination finding of MPS is the trigger point.
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Introduction The etiology of the trigger point is poorly understood.
Treatment of MPS is diverse and includes steroids,NSAIDs, antidepressants, physiotherapy/exercise and trigger point injections .
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Introduction Dry needling of the trigger point, as well as the injection of various substances including local anesthetics and botulinum toxin have been shown to be effective. BTX A is a potent neurotoxin that blocks the release of acetylcholine at the neuromuscular junction and thereby inhibits muscle contraction.
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The purpose of our study was to compare the effectiveness of trigger point injections using BTX A versus bupivacaine in combination with a home-based rehabilitation program for the treatment of MPS.
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Group A: Botulinum Group B:Bupivacaine
Methods Assessment at Baseline Study PopulationRandomization (N=18) Group A: Botulinum Group B:Bupivacaine toxin A (N=9) (N=9) Followed until pain returned to 75% of pre-injection pain based on weekly self reported average VAS pain score over preceding week Self-Reported questionnaires of satisfaction, cost, function measured every two weeks Washout 2 Weeks
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Group B:Bupivacaine GroupA: Botulinum
Methods Group B:Bupivacaine GroupA: Botulinum (N=9) toxin A (N=9) Followed until pain returned to 75% of pre-injection pain based on weekly self reported average VAS pain score over preceding week Self-Reported questionnaires of satisfaction, cost, function measured every two weeks Withdrawn (N=0) Withdrawn (N=1) Completed Trial (N=9) Completed Trial(N=8)
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Results Mean age = 51.1 years Female = 9 Male = 8
Average preinjection pain intensity = 6.9 Average number of trigger points injected per subject = 6.1
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Results No significant difference between BTX A and 0.5% bupivacaine in the magnitude, duration of pain relief and speed of pain relief response
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Results No difference in indirect and direct costs incurred to the subjects The amount of medication used was also not different between groups No difference in the first satisfaction measure or the second satisfaction measure
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Discussion No differences between the two agents
These findings are in agreement with some previous studies (Kamanli et al., 2004; Wheeler et al., 1998; Wheeler et al., 2001) but in disagreement with others (Cheshire,1994; Freund and Schwartz, 2000; Lang, 2000; Porta, 2000).
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Discussion A less likely explanation for the similar results of BTX A and 0.5% bupivacaine is incorrect dosing. The site of administration of the BTX A injections may be another factor in effectiveness as a treatment for myofascial pain.
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Discussion The mean duration of pain relief in our study was only 4 weeks. When the cost of the injectate is excluded, there was no significant difference in cost of care between the two groups. However, when the cost of the injectate is considered, it was quite a different story.
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Conclusions No benefit to injecting BTX A over 0.5% bupivacaine in any outcome measure when combined with a home based exercise program for the treatment of MPS.
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