Botulinum Toxin Injections for Thoracic Outlet Syndrome

NCT01405482 | Unknown Phase 1 DMC

• 1 other identifier: H11-00407
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Outlet Syndrome

Keywords

Botulinum Toxin Type A; Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Paresthesias on Numeric Rating Scale

  Change from baseline at six weeks and four months

• Function on DASH scale

  change from baseline at 6 weeks and 4 monthss

Study Arms (2)

Botulinum Toxin Type A injection

ACTIVE COMPARATOR

Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of BTX-A into the scalene muscles and pectoralis minor muscle under EMG guidance.

Drug: Botulinum Toxin Type A

Normal Saline

PLACEBO COMPARATOR

Double-blind, randomized, placebo-controlled trial evaluating changes in pain, paresthesias, and function in subjects with TOS before, at six weeks, and four months following injection of placebo into the scalene muscles under EMG guidance.

Other: Normal Saline injection

Interventions

Botulinum Toxin Type A DRUG

Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle

Also known as: Xeomin

Botulinum Toxin Type A injection

Normal Saline injection OTHER

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.

Also known as: Saline

Normal Saline

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 three months and less than two year
• 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 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

Sponsors & Collaborators

• University of British Columbia: lead
• Merz Pharmaceuticals: collaborator

Study Sites (1)

G F Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z-2G9, Canada

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Heather Finlayson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Finlayson, MD

CONTACT

604-714-4112; heather.finlayson@vch.ca

Jacqueline Foley, MD

CONTACT

778-863-4334; Jacqueline.foley@vch.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: July 29, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 29, 2011

Record last verified: 2011-07

Locations

CA (1)