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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

U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services, USA.gov
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I started experiencing TOS symptoms on my Left side (previous right side TOS Surgery). Had Marcaine injection in Left Scalene muscle ... it was a miracle I haven't felt that good in years... unfortuntately its diagnostic not a treatment and wears off in about 4 hours. I followed up the Marcaine with a Botox injection in Left Scalene. Symptoms in my arms subsided within about 2 -3 weeks. However I had an increase in pain in my neck for about 4.5 weeks. This has all resolved now, and I'm feeling really good. Unfortunately they'd told me that the Botox wears off in about 3-4 months. You can have multiple injections but apparently they become less affective over time

Here the result :

We studied the effect of botulinum toxin type A (BTX-A) injections to the scalene muscles on pain in subjects with thoracic outlet syndrome (TOS) in this double-blind, randomized, parallel group trial with follow-up at 6weeks, 3months, and 6months. Thirty-eight patients referred to physiatrists for management of TOS with BTX-A injection were included. One subject was lost to follow-up and all other subjects completed the trial. A 75-unit dose of BTX-A reconstituted with 0.75cc of normal saline was injected to the anterior scalene (37.5units) and middle scalene (37.5units) muscles using electromyographic guidance. The primary outcome measure was pain as measured on a horizontal visual analog scale (VAS) 6weeks-post-injection. Secondary outcomes were paresthesias measured on a VAS and function measured with the Disabilities of the Arm, Shoulder and Hand (DASH) and Short-form 36 (SF-36) questionnaires. For the primary outcome measure of VAS scores for pain at 6weeks, the difference in the means adjusted for baseline VAS scores between placebo and BTX-A was 5.03mm in favor of BTX-A (95% confidence interval -15.7 to 5.7, P=.36). Changes in secondary outcome measures were also not statistically significant. We conclude that BTX-A injections to the scalene muscles did not result in clinically or statistically significant improvements in pain, paresthesias, or function in this population of subjects with TOS.

Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

http://www.ncbi.nlm.nih.gov/pubmed/21628084

thats surprising! anyone got theories about why it didnt work

im thinking it helps with spasms, there's probably a study just testing that