NCT00444886

Treatment of Thoracic Outlet Syndrome (TOS) With Botox

Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is: 1. To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS. 2. To assess the effect of BOTOX injection on numbness and tingling and quality of life.

Detailed description

Background: Thoracic Outlet Syndrome (TOS) is a symptom complex consisting of pain, paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb. Impingement may occur at the interscalene triangle, and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of TOS in non-randomized controlled trials. Objective: To assess the effect of Botulinum Toxin Type A (BTX-A) injections into the scalene muscles on pain, paresthesias and function in subjects with TOS. Hypothesis: BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo. Intervention: Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.

Conditions

• Thoracic Outlet Syndrome

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A injection (BOTOX)	Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.
DRUG	Botulinum Toxin Type A injection (BOTOX)	Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2007-03-08
• Last updated: 2011-02-10

Locations

1 site across 1 country: Canada