Treatment of Thoracic Outlet Syndrome (TOS) With Botox - Full Text View

Sponsors and Collaborators:	University of British Columbia Allergan
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00444886

Purpose

The purpose of this study is:

To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.
To assess the effect of BOTOX injection on numbness and tingling and quality of life.

Condition	Intervention	Phase
Thoracic Outlet Syndrome	Drug: Botulinum Toxin Type A injection (BOTOX)	Phase II

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Botox Thoracic Outlet Syndrome

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention [ Time Frame: 6 monhts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Paresthesias as measured on VAS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444886

Contacts

Contact: Heather Finlayson, MD, FRCPC

604-714-4112

heather.finlayson@vch.ca

Locations

Canada, British Columbia
GF Strong Rehabilitation Centre	Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Heather Finlayson, MD, FRCPC 604-714-4112
Sub-Investigator: Russell O'Connor, MD
Sub-Investigator: Heather Finlayson, MD, FRCPC

Sponsors and Collaborators

University of British Columbia

Allergan

Investigators

Principal Investigator:

Andrew Travlos, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Heather Finlayson )
Study ID Numbers:	H06-03355, Data not known
Study First Received:	March 7, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00444886 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Thoracic Outlet Syndrome (TOS)
Botulinum Toxin
Botox
Pain

Study placed in the following topic categories:

Roussy Levy Hereditary Areflexic Dystasia
Charcot Marie Tooth Disease
Charcot-Marie-Tooth Disease
Vascular Diseases
Pain
Tomaculous Neuropathy
Nerve Compression Syndromes

Thoracic Outlet Syndrome
Botulinum Toxins
Neuromuscular Diseases
Peripheral Nervous System Diseases
Hereditary Motor and Sensory Neuropathies
Peripheral Nervous System Agents
Botulinum Toxin Type A

Additional relevant MeSH terms:

Disease
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Vascular Diseases
Neuromuscular Agents
Pharmacologic Actions
Nerve Compression Syndromes
Thoracic Outlet Syndrome
Pathologic Processes

Botulinum Toxins
Neuromuscular Diseases
Therapeutic Uses
Syndrome
Peripheral Nervous System Diseases
Cardiovascular Diseases
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009