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Treatment of Thoracic Outlet Syndrome (TOS) With Botox
This study is not yet open for patient recruitment.
Verified by University of British Columbia March 2007
Sponsors and Collaborators: University of British ColumbiaAllergan
Information provided by: University of British Columbia ClinicalTrials.gov Identifier: NCT00444886
Purpose
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.

Condition Intervention Phase Thoracic Outlet Syndrome
Drug: Botulinum Toxin Type A injection (BOTOX)
Phase II

MedlinePlus related topics: Thoracic Outlet Syndrome

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial
Further study details as provided by University of British Columbia:
Primary Outcome Measures:

• Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention

Secondary Outcome Measures:

• Paresthesias as measured on VAS
• Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work

Total Enrollment: 40
Study start: May 2007; Expected completion: May 2009

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.

Eligibility
Ages Eligible for Study: 19 Years and above, Genders Eligible for Study: Both
Criteria
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

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00444886
Heather Finlayson, MD, FRCPC 604-714-4112 heather.finlayson@vch.ca


Canada, British Columbia
GF Strong Rehabilitation Centre, Vancouver, British Columbia, V5Z 2G9, Canada Heather Finlayson, MD, FRCPC 604-714-4112
Russell O'Connor, MD, Sub-Investigator
Heather Finlayson, MD, FRCPC, Sub-Investigator



Study chairs or principal investigators

Andrew Travlos, MD, Principal Investigator, University of British Columbia
More Information
Study ID Numbers: H06-03355
Last Updated: March 7, 2007
Record first received: March 7, 2007
ClinicalTrials.gov Identifier: NCT00444886
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on June 21, 2007

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