Clinical trial NCT01405482: Botulinum Toxin Injections for Thoracic Outlet Syndrome
Official title: Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Thoracic Outlet Syndrome
Keywords: Botulinum Toxin Type A
Thoracic Outlet Syndrome
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Merz Pharmaceuticals
First posted: 2011-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Study design:

Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection.

Study population:

Sixty subjects at least eighteen years of age with a clinical diagnosis of TOS of at least three months duration but less than one year, referred to our practice for management of TOS.

Intervention:

Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 100 units of BTX-A (experimental group), or normal saline (control group). Outcome measures:

The primary outcome measure will be pain as measured on a ten point Numeric Rating Scale with a two point reduction considered significant. Secondary outcomes will be paresthesias as measured on a Numeric Rating Scale, function measured on the Disabilities of the arm, shoulder and hand (DASH) questionnaire.

Eligibility 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 three months and less than two year
* 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 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

Primary outcomes:
measure: Pain
timeFrame: Change from baseline at six weeks and four months
Secondary outcomes:
measure: Paresthesias on Numeric Rating Scale
timeFrame: Change from baseline at six weeks and four months
measure: Function on DASH scale
timeFrame: change from baseline at 6 weeks and 4 monthss
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: G F Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Heather Finlayson, MD
role: PRINCIPAL_INVESTIGATOR
References: