NCT00404417

Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain

Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain: A Prospective Randomized Double-blind Placebo-controlled Crossover Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Walter Reed Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will assess the efficacy and the duration of efficacy of Botulinum toxin A (Botox®) injected into the lumbar paraspinal muscles for reducing pain and disability in subjects suffering from chronic low back pain of six months duration or longer and arising from an identifiable muscle strain injury or back trauma. The treatment modality and techniques used are based on a successful prior 4 month open-labeled pilot study done by this research group, but will employ a prospective double-blind, randomized, cross-over design to control for any placebo or mechanical trigger-point injection effects. Subjects will also be assessed for a longer duration to better define the duration of efficacy.

Detailed description

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. This will result in half of the subjects being crossed-over from Botox® to placebo (study arm Botox/placebo) or vice versa (study arm placebo/Botox) and one quarter of subjects receiving two courses of either Botox® alone (Botox/Botox) or placebo alone (placebo/placebo). All subjects will continue to receive medication and/or physiotherapy per standard of care but those treatments will be recorded and controlled for in the data analysis.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Botulinum Toxin A / Placebo	Botulinum Toxin A at first injection / Placebo at second injection
DRUG	Botulinum Toxin A / Botulinum Toxin A	Botulinum Toxin A at first injection / Botulinum Toxin A at second injection
DRUG	Placebo / Botulinum Toxin A	Placebo at first injection / Botulinum Toxin A at second injection
DRUG	Placebo / Placebo	Placebo at first injection / Placebo at second injection

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2006-11-28
• Last updated: 2010-03-02

Locations

1 site across 1 country: United States