Botulinum Toxin Injections for Thoracic Outlet Syndrome

Study Overview
=================
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.

Official Title
-----------------
Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial

Conditions
-----------------
Thoracic Outlet Syndrome

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Other: Normal Saline injection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum Toxin Type A injection<br>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<br>* Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle<br>* Other names: Xeomin;|
| Placebo Comparator: Normal Saline<br>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<br>* 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.<br>* Other names: Saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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. | Change from baseline at six weeks and four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paresthesias on Numeric Rating Scale | Secondary outcomes will be change from baseline in paresthesias as measured on a Numeric Rating Scale at baseline, six weeks and four months. | Change from baseline at six weeks and four months | 
| Function on DASH scale | 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. | change from baseline at 6 weeks and 4 monthss | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Botulinum Toxin Type A, Thoracic Outlet Syndrome