Botulinum Toxin Injections for Thoracic Outlet Syndrome
NCT ID: NCT01405482
Last Updated: 2011-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2011-08-31
2013-06-30
Brief Summary
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Detailed Description
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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.
Study design:
Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection.
Study population:
Sixty subjects at least eighteen years of age with a clinical diagnosis of TOS of at least three months duration but less than one year, referred to our practice for management of TOS.
Intervention:
Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 100 units of BTX-A (experimental group), or normal saline (control group). Outcome measures:
The primary outcome measure will be pain as measured on a ten point Numeric Rating Scale with a two point reduction considered significant. Secondary outcomes will be paresthesias as measured on a Numeric Rating Scale, function measured on the Disabilities of the arm, shoulder and hand (DASH) questionnaire.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Botulinum Toxin Type A injection
Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of BTX-A into the scalene muscles and pectoralis minor muscle under EMG guidance.
Botulinum Toxin Type A
Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle
Normal Saline
Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of placebo into the scalene muscles under EMG guidance.
Normal Saline injection
10 cc of Normal Saline will be injected under EMG guidance into the Anterior and Middle Scalenes and Pectoralis Minor muscle of individual diagnosed with Thoracic Outlet Syndrome.
Interventions
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Botulinum Toxin Type A
Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle
Normal Saline injection
10 cc of Normal Saline will be injected under EMG guidance into the Anterior and Middle Scalenes and Pectoralis Minor muscle of individual diagnosed with Thoracic Outlet Syndrome.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
19 Years
ALL
No
Sponsors
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Merz Pharmaceuticals
INDUSTRY
University of British Columbia
OTHER
Responsible Party
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University of British Columbia - Vancouver Coastal Health Research Institute
Principal Investigators
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Heather Finlayson, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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G F Strong Rehabilitation Centre
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Other Identifiers
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H11-00407
Identifier Type: -
Identifier Source: org_study_id