Treatment of Thoracic Outlet Syndrome (TOS) With Botox

NCT00444886 | Completed Phase 2

• 2 other identifiers: H06-03355Data not known
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

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

Conditions

Thoracic Outlet Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention

  6 monhts

Secondary Outcomes (2)

• Paresthesias as measured on VAS

  6 months

• Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work

  6 months

Study Arms (2)

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)

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)

Interventions

Botulinum Toxin Type A injection (BOTOX) DRUG

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.

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Allergan: collaborator

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome; Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Andrew Travlos, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 10, 2011

Record last verified: 2011-02

Locations

CA (1)