Thoracic Outlet SyndromePhase 1NCT01405482
Botulinum Toxin Injections for Thoracic Outlet Syndrome
A Phase 1 study testing Botulinum Toxin Type A and Normal Saline injection in people with Thoracic Outlet Syndrome, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Botulinum Toxin Type A and Normal Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
G F Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z-2G9
Heather Finlayson, MD
About this study
Official title: Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial
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.
Read the 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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Botulinum Toxin Type A, Normal Saline injection
- Keywords
- Botulinum Toxin Type A, Thoracic Outlet Syndrome
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Xeomin
Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle
Normal Saline injectionOther
Also called Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at six weeks and four months
Secondary outcomes (2)
Paresthesias on Numeric Rating Scale
Secondary outcomes will be change from baseline in paresthesias as measured on a Numeric Rating Scale at baseline, six weeks and four months.
Measured: Change from baseline at six weeks and four months
Function on DASH scale
Secondary outcome will be change from baseline in function on the Disabilities of the arm, shoulder, hand questionnaire at six weeks and at four months.
Measured: change from baseline at 6 weeks and 4 monthss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Investigators
- Heather Finlayson, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405482
- Sponsor's protocol ID
- H11-00407
- Status last verified
- Jul 2011
- First submitted
- 23 Jun 2011
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulin Toxin Type A Injections for Thoracic Outlet Syndrome: A Double-Blind, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01405482
- Acronym / sponsor ID
- H11-00407
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Botulinum Toxin Type A, Thoracic Outlet Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A injection | Active comparator | Drug: Botulinum Toxin Type ADouble-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. |
| Normal Saline | Placebo comparator | Other: Normal Saline injectionDouble-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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Prior treatment with BTX-A
- Allergy to BTX-A
- History of botulinum toxicity
- Prior scalenectomy
- Surgery for TOS planned within four months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: XeominBotulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle | Drug | Botulinum Toxin Type A injection |
| Normal Saline injectionAlso: Saline10 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. | Other | Normal Saline |
Primary outcome
Pain
Time frame: Change from baseline at six weeks and four months
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.
2 secondary outcomes
Paresthesias on Numeric Rating Scale
Time frame: Change from baseline at six weeks and four months
Function on DASH scale
Time frame: change from baseline at 6 weeks and 4 monthss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Finlayson, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum Toxin Type A and Normal Saline injection in people with Thoracic Outlet Syndrome, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Finlayson, MD (604-714-4112, heather.finlayson@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from baseline at six weeks and four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.