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Botulinum Toxin Injections for Thoracic Outlet Syndrome

This study is not yet open for participant recruitment.
Verified July 2011 by University of British Columbia
Sponsor:
Collaborator:
Merz Pharma Canada
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01405482
First received: June 23, 2011
Last updated: July 28, 2011
Last verified: July 2011
History of Changes
  Purpose

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 lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.


Condition Intervention Phase
Thoracic Outlet Syndrome
 Drug: Botulinum Toxin Type A
Other: Normal Saline injection
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Pain [ Time Frame: Change from baseline at six weeks and four months ] [ Designated as safety issue: No ]
    The primary outcome measure will be change in baseline pain as measured on a ten point Numeric Scale and will be assessed at six weeks and four months following injection.


Secondary Outcome Measures:
  • Paresthesias on Numeric Rating Scale [ Time Frame: Change from baseline at six weeks and four months ] [ Designated as safety issue: No ]
    Secondary outcomes will be change from baseline in paresthesias as measured on a Numeric Rating Scale at baseline, six weeks and four months.

  • Function on DASH scale [ Time Frame: change from baseline at 6 weeks and 4 monthss ] [ Designated as safety issue: No ]
    Secondary outcome will be change from baseline in function on the Disabilities of the arm, shoulder, hand questionnaire at six weeks and at four months.


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Drug: 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
Other Name: Xeomin
Placebo Comparator: 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.
 Other: 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 Name: Saline

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 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 three months and less than two year
  • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405482

Contacts
Contact: Heather Finlayson, MD 604-714-4112 heather.finlayson@vch.ca
Contact: Jacqueline Foley, MD 778-863-4334 Jacqueline.foley@vch.ca

Locations
Canada, British Columbia
G F Strong Rehabilitation Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z-2G9
Principal Investigator: Heather Finlayson, MD            
Sponsors and Collaborators
University of British Columbia
Merz Pharma Canada
Investigators
Principal Investigator: Heather Finlayson, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Heather Finlayson, University of British Columbia - Vancouver Coastal Health Research Institute
ClinicalTrials.gov Identifier: NCT01405482     History of Changes
Other Study ID Numbers: H11-00407
Study First Received: June 23, 2011
Last Updated: July 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Botulinum Toxin Type A
Thoracic Outlet Syndrome

Additional relevant MeSH terms:
Thoracic Outlet Syndrome
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
 Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013