Treatment of Thoracic Outlet Syndrome (TOS) With Botox

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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 and quality of life.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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