Treatment of Thoracic Outlet Syndrome (TOS) With Botox

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00444886
Study type	Interventional
Source	University of British Columbia
Contact
Status	Completed
Phase	Phase 2
Start date	May 2007
Completion date	February 2011

View Details

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