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
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Outlet Syndrome||Drug: Botulinum Toxin Type A Other: Normal Saline injection||Phase 1|
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.
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.
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.
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405482
|Contact: Heather Finlayson, MDfirstname.lastname@example.org|
|Contact: Jacqueline Foley, MD||778-863-4334||Jacqueline.email@example.com|
|Canada, British Columbia|
|G F Strong Rehabilitation Centre|
|Vancouver, British Columbia, Canada, V5Z-2G9|
|Principal Investigator: Heather Finlayson, MD|
|Principal Investigator:||Heather Finlayson, MD||University of British Columbia|