Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain

Summary

This study will test the hypothesis that Botulinum toxin B (Myobloc®) treatment reduces pain and disability in subjects suffering from acute low back pain due to an identifiable muscle strain or back trauma occurring 3 to 6 weeks prior to enrollment. The study will also delineate the duration of medication effect and control for any placebo or mechanical trigger-point injection effect by employing a prospective, double-blind, placebo-controlled design.

Timeline

Start

2008-02

Primary completion

2010-08

Completion

2010-08

Publications

• Background Wipf JE, Deyo RA. Low back pain. Med Clin North Am. 1995 Mar;79(2):231-46. doi: 10.1016/s0025-7125(16)30065-7.
• Background Frymoyer JW. Predicting disability from low back pain. Clin Orthop Relat Res. 1992 Jun;(279):101-9.
• Background Lew MF, Brashear A, Factor S. The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Neurology. 2000;55(12 Suppl 5):S29-35.
• Background Rand MJ, Whaler BC. Impairment of sympathetic transmission by botulinum toxin. Nature. 1965 May 8;206(984):588-91. doi: 10.1038/206588a0. No abstract available.
• Background Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. doi: 10.1016/j.neuro.2005.01.017. Epub 2005 Jul 5.
• Background 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. doi: 10.1212/wnl.56.10.1290.
• Background Aoki KR. Pharmacology and immunology of botulinum toxin serotypes. J Neurol. 2001 Apr;248 Suppl 1:3-10. doi: 10.1007/pl00007816.

Drugs

Indications

No indication recorded.