Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-Acute Low Back Pain

Summary

This study will test the hypothesis that Botulinum toxin A (BOTOX®) treatment reduces pain and disability in subjects suffering from sub-acute low back pain due to an identifiable muscle strain or back trauma occurring 6 to 16 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

2008-06

Primary completion

2011-09

Completion

2011-09

Outcome

Outcome not reported

Stopped (Business): “Funding was unable to be secured for this study”

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 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. doi: 10.1002/mds.870090221.
• 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 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.
• 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.

Drugs

Indications

No indication recorded.