One hundred sixty subjects will be randomly assigned to one of four arms
(placebo/placebo, placebo/Botox, Botox/placebo, Botox/Botox). In the first
of two phases, randomized subjects will blindly receive either Botox®
(study arms Botox/placebo and Botox/Botox) or placebo (study arms
placebo/placebo and placebo/Botox) injection into the lumbar paraspinal
muscles. The subjects will be assessed using validated scales for pain and
disability prior to injection and monthly thereafter for four months. In
the second phase, a second set of lumbar injections will be administered
based on the initial randomization and will blindly receive either Botox®
(study arms placebo/Botox and Botox/Botox) or placebo (study arms
placebo/placebo and Botox/placebo) injection into the lumbar paraspinal
muscles. The subjects will again be assessed using the same validated
scales for pain and disability, prior to injection and monthly thereafter,
but for six months to extend the monitoring period to better define the
limits of duration of effect.
For The Full Story:
http://clinicaltrials.gov/ct/show/NCT00404417?order=2
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