Status:
UNKNOWN
Botulinum Toxin Injections for Thoracic Outlet Syndrome
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Merz Pharmaceuticals
Conditions:
Thoracic Outlet Syndrome
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
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 lea...
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 m...
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 three months and less than two year
- 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 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01405482
Start Date
August 1 2011
End Date
June 1 2013
Last Update
July 29 2011
Active Locations (1)
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1
G F Strong Rehabilitation Centre
Vancouver, British Columbia, Canada, V5Z-2G9