Botulinum Toxin Injections for Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01405482
• Other study ID #: H11-00407
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 23, 2011
• Last updated: July 28, 2011
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2011
• Source: University of British Columbia
• Contact: Heather Finlayson, MD
• Phone: 604-714-4112
• Email: heather.finlayson[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

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:
• 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.

Locations

Country	Name	City	State
Canada	G F Strong Rehabilitation Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Merz Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No