Status:
COMPLETED
Treatment of Thoracic Outlet Syndrome (TOS) With Botox
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Allergan
Conditions:
Thoracic Outlet Syndrome
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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 a...
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. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00444886
Start Date
May 1 2007
End Date
February 1 2011
Last Update
February 10 2011
Active Locations (1)
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1
GF Strong Rehabilitation Centre
Vancouver, British Columbia, Canada, V5Z 2G9