Treatment of Thoracic Outlet Syndrome (TOS) With Botox

• ClinicalTrials.gov Identifier: NCT00444886
• Recruitment Status: Completed
• First Posted: March 8, 2007
• Last Update Posted: February 10, 2011
• Sponsor: University of British Columbia
• Collaborator: Allergan
• Information provided by: University of British Columbia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Thoracic Outlet Syndrome	Drug: Botulinum Toxin Type A injection (BOTOX)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial
• Study Start Date: May 2007
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: February 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.	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.
Active Comparator: 2; To assess the effect of BOTOX injection on numbness and tingling and quality of life.	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.

Outcome Measures

Primary Outcome Measures :

1. Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention [ Time Frame: 6 monhts ]

Secondary Outcome Measures :

1. Paresthesias as measured on VAS [ Time Frame: 6 months ]
2. Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Locations

Canada, British Columbia

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada, V5Z 2G9

Sponsors and Collaborators

University of British Columbia

Allergan

Investigators

• Principal Investigator: Andrew Travlos, MD; University of British Columbia

More Information

• Responsible Party: Heather Finlayson, University of British Columbia
• ClinicalTrials.gov Identifier: NCT00444886
• Other Study ID Numbers: H06-03355; Data not known
• First Posted: March 8, 2007
• Last Update Posted: February 10, 2011
• Last Verified: February 2011

Keywords provided by University of British Columbia:

Thoracic Outlet Syndrome (TOS); Botulinum Toxin; Botox; Pain

Additional relevant MeSH terms:

Nerve Compression Syndromes; Thoracic Outlet Syndrome; Syndrome; Disease; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents