Thoracic Outlet SyndromePhase 2NCT00444886
Treatment of Thoracic Outlet Syndrome (TOS) With Botox
A Phase 2 study testing Botulinum Toxin Type A injection (BOTOX) in people with Thoracic Outlet Syndrome, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is: 1. To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS. 2. To assess the effect of BOTOX injection on numbness and tingling and quality of life. 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 injection (BOTOX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Feb 2011
- Phase
- Phase 2
- 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 six months
- 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 six 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, 3 months and 6 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
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Botulinum Toxin Type A injection (BOTOX)
- Keywords
- Thoracic Outlet Syndrome (TOS), Botulinum Toxin, Botox, Pain
- Medical subject headings
- Thoracic Outlet Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS. Receives: 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. Receives: Drug: Botulinum Toxin Type A injection (BOTOX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention
Measured: 6 monhts
Secondary outcomes (2)
Paresthesias as measured on VAS
Measured: 6 months
Function as measured with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, SF-36, number of days lost from work
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2011
- Study completionFeb 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Andrew Travlos, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444886
- Sponsor's protocol ID
- H06-03355
- Other IDs
- Data not known
- Status last verified
- Feb 2011
- First submitted
- 7 Mar 2007
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00444886
- Acronym / sponsor ID
- H06-03355
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Thoracic Outlet Syndrome (TOS), Botulinum Toxin, Botox, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- May 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Mar 2007 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Botulinum Toxin Type A injection (BOTOX)To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS. |
| 2 | Active comparator | Drug: Botulinum Toxin Type A injection (BOTOX)To assess the effect of BOTOX injection on numbness and tingling and quality of life. |
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 six months
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 six 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 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. | Drug | 1 |
| 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. | Drug | 2 |
Primary outcome
Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention
Time frame: 6 monhts
2 secondary outcomes
Paresthesias as measured on VAS
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Andrew Travlos, 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 2 study testing Botulinum Toxin Type A injection (BOTOX) 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: finished, as of the sponsor's last update on 10 Feb 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as measured on Visual Analog Scale (VAS) at 6 weeks, 3 months and 6 months post-intervention (time frame: 6 monhts). 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 10 Feb 2011.