Thoracic Outlet Syndrome Clinical Trial
Official title:
Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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