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Trial record 2 of 2 for:    "Thoracic Outlet Syndrome" | "Botulinum Toxins, Type A"

Botulinum Toxin Injections for Thoracic Outlet Syndrome

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ClinicalTrials.gov Identifier: NCT01405482
Recruitment Status : Unknown
Verified July 2011 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
Sponsor:
Collaborator:
Merz Pharmaceuticals
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date  ICMJE June 23, 2011
First Posted Date  ICMJE July 29, 2011
Last Update Posted Date July 29, 2011
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
Pain [ Time Frame: Change from baseline at six weeks and four months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • Paresthesias on Numeric Rating Scale [ Time Frame: Change from baseline at six weeks and four months ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Injections for Thoracic Outlet Syndrome
Official Title  ICMJE Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial
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 lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Thoracic Outlet Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Botulinum Toxin Type A
  • 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.
    Intervention: Other: Normal Saline injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01405482
Other Study ID Numbers  ICMJE H11-00407
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Heather Finlayson, University of British Columbia - Vancouver Coastal Health Research Institute
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Merz Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Heather Finlayson, MD University of British Columbia
PRS Account University of British Columbia
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP