NCT00384371 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Foster L, Clapp L, Erickson M, Jabbari B
Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology. 2001 May 22;56(10):1290-3.
Frymoyer JW
Predicting disability from low back pain. Clin Orthop Relat Res. 1992 Jun;(279):101-9. Review.
Haig AJ, LeBreck DB, Powley SG
Paraspinal mapping. Quantified needle electromyography of the paraspinal muscles in persons without low back pain. Spine (Phila Pa 1976). 1995 Mar 15;20(6):715-21.
Polo KB, Jabbari B
Effectiveness of botulinum toxin type A against painful limb myoclonus of spinal cord origin. Mov Disord. 1994 Mar;9(2):233-5.
Rand MJ, Whaler BC
Impairment of sympathetic transmission by botulinum toxin. Nature. 1965 May 8;206(984):588-91.
Wipf JE, Deyo RA
Low back pain. Med Clin North Am. 1995 Mar;79(2):231-46. Review.

Pilot Study to Assess the Efficacy of Botulinum Toxin A (BOTOX®) Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Sub-Acute Low Back Pain.

Details for clinical trial NCT00384371

Clinical trial NCT00384371 - References