Botulinum Toxin Injections for Thoracic Outlet Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Drug: Botulinum Toxin Type A; Other: Normal Saline injection

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z-2G9
      • G F 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 three months and less than two year
• 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 four 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 and 4 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum Toxin Type A injection; Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of BTX-A into the scalene muscles and pectoralis minor muscle under EMG guidance.	Drug: Botulinum Toxin Type A; Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle; Other Names: Xeomin
Placebo Comparator: Normal Saline; Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of placebo into the scalene muscles under EMG guidance.	Other: Normal Saline injection; 10 cc of Normal Saline will be injected under EMG guidance into the Anterior and Middle Scalenes and Pectoralis Minor muscle of individual diagnosed with Thoracic Outlet Syndrome.; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	The primary outcome measure will be change in baseline pain as measured on a ten point Numeric Scale and will be assessed at six weeks and four months following injection.	Change from baseline at six weeks and four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paresthesias on Numeric Rating Scale	Secondary outcomes will be change from baseline in paresthesias as measured on a Numeric Rating Scale at baseline, six weeks and four months.	Change from baseline at six weeks and four months
Function on DASH scale	Secondary outcome will be change from baseline in function on the Disabilities of the arm, shoulder, hand questionnaire at six weeks and at four months.	change from baseline at 6 weeks and 4 monthss

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Merz Pharmaceuticals
• Investigators: Principal Investigator: Heather Finlayson, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2011
• Last Update Submitted That Met QC Criteria: July 28, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Botulinum Toxin Type A; Thoracic Outlet Syndrome
• 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: H11-00407