Treatment of Thoracic Outlet Syndrome (TOS) With Botox

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Drug: Botulinum Toxin Type A injection (BOTOX)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • GF Strong Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age at least 19 years
• Medically stable
• Able to give informed consent
• Meets criteria for clinical diagnosis of TOS
• Symptoms of TOS present for at least six months
• Have had EMG studies and a CT or MRI scan of the cervical spine

Exclusion Criteria:

• Prior treatment with BTX-A
• Allergy to BTX-A
• History of botulinum toxicity
• Prior scalenectomy
• Surgery for TOS planned within six months
• Use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin
• History of Myasthenia Gravis, Eaton-Lambert Syndrome or Shy-Drager Syndrome
• Unable to complete follow-up assessments at 6 weeks, 3 months and 6 months
• Any abnormalities on EMG, CT or MRI studies suggesting an alternate diagnosis
• Pregnancy or planned pregnancy within six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.	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.
Active Comparator: 2; To assess the effect of BOTOX injection on numbness and tingling and quality of life.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention	6 monhts

Secondary Outcome Measures

Outcome Measure	Time Frame
Paresthesias as measured on VAS	6 months
Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work	6 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Allergan
• Investigators: Principal Investigator: Andrew Travlos, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 7, 2007
• First Submitted That Met QC Criteria: March 7, 2007
• First Posted (Estimate): March 8, 2007

Study Record Updates

• Last Update Posted (Estimate): February 10, 2011
• Last Update Submitted That Met QC Criteria: February 9, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Pain; Botulinum Toxin; Botox; Thoracic Outlet Syndrome (TOS)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: H06-03355; Data not known