Botulinum Toxin Injections for Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

Official title: Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial

Status Not yet recruiting

Clinical Trial Summary

Botulinum toxin type 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.

Clinical Trial Description

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.

Study design:

Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection.

Study population:

Sixty subjects at least eighteen years of age with a clinical diagnosis of TOS of at least three months duration but less than one year, referred to our practice for management of TOS.

Intervention:

Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 100 units of BTX-A (experimental group), or normal saline (control group). Outcome measures:

The primary outcome measure will be pain as measured on a ten point Numeric Rating Scale with a two point reduction considered significant. Secondary outcomes will be paresthesias as measured on a Numeric Rating Scale, function measured on the Disabilities of the arm, shoulder and hand (DASH) questionnaire. ;

Study Design

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

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

• NCT number: NCT01405482
• Study type: Interventional
• Source: University of British Columbia
• Contact: Heather Finlayson, MD
• Phone: 604-714-4112
• Email: heather.finlayson@vch.ca
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2011
• Completion date: June 2013