Treatment of Thoracic Outlet Syndrome (TOS) With Botox

Thoracic Outlet Syndrome Clinical Trial

Official title:

Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444886
• Other study ID #: H06-03355
• Secondary ID: Data not known
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: February 9, 2011
• Start date: May 2007
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is:

1. To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.

2. To assess the effect of BOTOX injection on numbness and tingling and quality of life.

Description:

Background:

Thoracic Outlet Syndrome (TOS) is a symptom complex consisting of pain, paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb. Impingement may occur at the interscalene triangle, and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of TOS in non-randomized controlled trials.

Objective:

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.

Intervention:

Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• 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 six months

• 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 six 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, 3 months and 6 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

Drug:
• Botulinum Toxin Type A injection (BOTOX)
Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.
• Botulinum Toxin Type A injection (BOTOX)
Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.

Locations

Country	Name	City	State
Canada	GF Strong Rehabilitation Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention		6 monhts	No
Secondary	Paresthesias as measured on VAS		6 months	No
Secondary	Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work		6 months	No