Thoracic Outlet SyndromePhase 4NCT05536570
Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin.
A Phase 4 study testing IncobotulinumtoxinA 100 UNT in people with Thoracic Outlet Syndrome and Whiplash Injuries, run by King, David, MD at 1 site in Canada.
Trial summary
Whiplash injuries following car accident are common, it has been reported to affect 83% of individuals injured in traffic collisions (Yadla S, 2007). The condition is caused by a rapid acceleration followed immediately by a rapid deceleration of the neck and head. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Outlet Syndrome, Whiplash Injuries
- What is being tested?
- IncobotulinumtoxinA 100 UNT
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2022to 15 Jun 2023
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patient must have been diagnosed with a muscle strain to the lateral neck muscles following a car accident and there must be the following clinical signs of TOS: pain in the proper distribution, weakened grip, shoulder elevation on the appropriate side and numbness or tingling in the arm or fingers;
- Patient must have no signs suggesting a radiculopathy that could account for similar symptoms;
- Patient must have a PDQ \>70, i.e. in the moderate to very severe disability range;
- Patient must experience symptoms for longer than 3 months;
- Patient must have had the accident leading to whiplash within the last 3 years;
- Patient must be 18 years of age or older;
Show all 10Show fewer
- Patient must be eligible and agreeable to treatment with BoNT-A;
- Patient must be toxin-naïve for the treatment of the cervical region, or have undergone a six months washout period;
- Patient must be English speaking;
- Patient must be able to provide informed consent.
Who cannot join
- • Patient unable or unwilling to complete the necessary assessment tasks;
- Patient with hypersensitivity to botulinum neurotoxin type A or to any of the excipients, generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), or infection or inflammation at the proposed injection site(s);
- Patient who requires physiotherapy and/or massage therapy;
- Patient for whom concomitant medications are not controlled at study start and/or may require change/adjustment during the study;
- Patient who had surgery which may interfere with the study;
- Women who are pregnant or nursing, or women in age of reproduction not using a contraceptive method;
- Patient in active litigation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Private Office
Halifax, Nova Scotia, B3P 1M3
David B King, BSc, MD, 902 425 7344, david.larkspur@gmail.com
About this study
Official title: Management of Functional Thoracic Outlet Syndrome (TOS - Whiplash) With IncobotulinumtoxinA Injections
Whiplash injuries following car accident are common, it has been reported to affect 83% of individuals injured in traffic collisions (Yadla S, 2007). The condition is caused by a rapid acceleration followed immediately by a rapid deceleration of the neck and head. The annual North American incidence rate is estimated to be 600 per 100,000 people (Holm LW, 2008). The condition is costly for society and disabling/painful for the patients. Depending on the collision type, the biomechanics of muscles will be affected differently and consequently the clinical presentation will vary. T-bone type of car collisions (when the front of one vehicle strikes the side of another) may induce thoracic outlet syndrome (TOS) following compression on the nerve and artery bundle by the scalene muscles (lateral stabilizers of the neck). An appropriate and detailed examination of the patient is necessary to identify the cause of the resulting pain and disability. Once a functional thoracic outlet syndrome is identified the proposal is to treat this with botulinum toxin.
Read the detailed description
TOS symptoms will typical emerge within 24-48 hours following the accident. The duration will depend on the level of severity of the muscle damage. If the severity is a grade 1 (mild damage to individual muscle fibers), symptoms may last up to 3 weeks. If the severity is a grade 2 (more extensive damage with more muscle fibers involved/no complete rupture), symptoms may last up to 3 months. However, in many cases, due to muscle swelling and consequently compression of the nerve plexus, a persistent reflex spasm of muscle develops.
A potentially effective treatment strategy, in patients presenting TOS associated clinical symptoms in the proper distribution, is to relax the scalene muscles that surround the nerve plexus. Botulinum toxin, such as incobotulinumtoxinA (XEOMIN, Merz herapeutics), have been shown to be effective and safe in relaxing these muscles in conditions like spasticity, blepharospasm and cervical dystonia (Kanovský P, 2009; Benecke R, 2005; Roggenkämper P, 2005). It is hypothesised that a subtype of whiplash defined as functional TOS could be improved with incobotulinumtoxinA injections into the medial scalene muscle. IncobotulinumtoxinA when injected into the medial scalene is expected to induce muscle relaxation which leads to nerve plexus decompression. The effect is anticipated to last approximately 3 months, which is the duration of effect of botulinum toxins type A. A similar effect can be induced using a local anaesthetic, such xylocaine, since it has a similar mechanism of action, but his effect should be short lived.
- Conditions
- Thoracic Outlet Syndrome, Whiplash Injuries
- Being tested
- IncobotulinumtoxinA 100 UNT
- Medical subject headings
- Thoracic Outlet Syndrome, Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinA 100 UNTDrug
Scalene injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain disability as assessed using the PDQ at Week 4.
PDQ before and after treatment. Pain Disability Questionnaire (Guides to the Evaluation of Permanent Impairment, Sixth Edition.
0= No pain related impairment 1-70= Mild pain related impairment 71-100=Moderate pain related impairment 101-130= Severe pain related impairment 131-150= Extreme pain related impairment
Measured: week 4
Secondary outcomes (3)
Shoulder Elevation
Change from baseline in shoulder elevation as assessed by measurement on photograph (clavicular angle) at Weeks 4, 12 and 16;
Measured: week 4
Grip Strength
- Change from baseline in grip strength as assessed using a dynamometer at Weeks 4, 12 and 16;
Measured: Week 4
Pinch Test
- Change from baseline in fine motor test (pinch test) at Weeks 4, 12 and 16;
Measured: WFeek 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Jun 2023 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients who have neck pain and arm paresthesia following a side-on collision
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King, David, MD
- Collaborators
- MERZ PHARMA
- Responsible party
- Principal investigator, David King, King, David, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536570
- Sponsor's protocol ID
- EMSI-1
- Status last verified
- Sep 2022
- First submitted
- 27 Jul 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Functional Thoracic Outlet Syndrome (TOS - Whiplash) With IncobotulinumtoxinA Injections
- ClinicalTrials.gov ID
- NCT05536570
- Acronym / sponsor ID
- EMSI-1
- Conditions
- Thoracic Outlet Syndrome, Whiplash Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- King, David, MD
- Collaborators
- MERZ PHARMA
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 13 Sep 2022 (actual)
- 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.
Whiplash injuries following car accident are common, it has been reported to affect 83% of individuals injured in traffic collisions (Yadla S, 2007). The condition is caused by a rapid acceleration followed immediately by a rapid deceleration of the neck and head. The annual North American incidence rate is estimated to be 600 per 100,000 people (Holm LW, 2008). The condition is costly for society and disabling/painful for the patients. Depending on the collision type, the biomechanics of muscles will be affected differently and consequently the clinical presentation will vary. T-bone type of car collisions (when the front of one vehicle strikes the side of another) may induce thoracic outlet syndrome (TOS) following compression on the nerve and artery bundle by the scalene muscles (lateral stabilizers of the neck). An appropriate and detailed examination of the patient is necessary to identify the cause of the resulting pain and disability. Once a functional thoracic outlet syndrome is identified the proposal is to treat this with botulinum toxin.
Detailed description
TOS symptoms will typical emerge within 24-48 hours following the accident. The duration will depend on the level of severity of the muscle damage. If the severity is a grade 1 (mild damage to individual muscle fibers), symptoms may last up to 3 weeks. If the severity is a grade 2 (more extensive damage with more muscle fibers involved/no complete rupture), symptoms may last up to 3 months. However, in many cases, due to muscle swelling and consequently compression of the nerve plexus, a persistent reflex spasm of muscle develops.
A potentially effective treatment strategy, in patients presenting TOS associated clinical symptoms in the proper distribution, is to relax the scalene muscles that surround the nerve plexus. Botulinum toxin, such as incobotulinumtoxinA (XEOMIN, Merz herapeutics), have been shown to be effective and safe in relaxing these muscles in conditions like spasticity, blepharospasm and cervical dystonia (Kanovský P, 2009; Benecke R, 2005; Roggenkämper P, 2005). It is hypothesised that a subtype of whiplash defined as functional TOS could be improved with incobotulinumtoxinA injections into the medial scalene muscle. IncobotulinumtoxinA when injected into the medial scalene is expected to induce muscle relaxation which leads to nerve plexus decompression. The effect is anticipated to last approximately 3 months, which is the duration of effect of botulinum toxins type A. A similar effect can be induced using a local anaesthetic, such xylocaine, since it has a similar mechanism of action, but his effect should be short lived.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Patients who have neck pain and arm paresthesia following a side-on collision
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- • Patient must have been diagnosed with a muscle strain to the lateral neck muscles following a car accident and there must be the following clinical signs of TOS: pain in the proper distribution, weakened grip, shoulder elevation on the appropriate side and numbness or tingling in the arm or fingers;
Key exclusion criteria (7 listed)
- • Patient unable or unwilling to complete the necessary assessment tasks;
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 |
|---|---|---|
| IncobotulinumtoxinA 100 UNTScalene injection | Drug | – |
Primary outcome
Change from baseline in pain disability as assessed using the PDQ at Week 4.
Time frame: week 4
PDQ before and after treatment. Pain Disability Questionnaire (Guides to the Evaluation of Permanent Impairment, Sixth Edition. 0= No pain related impairment 1-70= Mild pain related impairment 71-100=Moderate pain related impairment 101-130= Severe pain related impairment 131-150= Extreme pain related impairment
3 secondary outcomes
Shoulder Elevation
Time frame: week 4
Grip Strength
Time frame: Week 4
Pinch Test
Time frame: WFeek 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Thoracic Outlet Syndrome
Recruiting
Motivational Interviewing in Thoracic Outlet Syndrome
Thoracic Outlet Syndrome
Recruiting
Immediate Effects of Kinesio Taping on Thoracic Outlet Syndrome
Thoracic Outlet Syndrome
Not yet recruiting
Effect of Mechanically Loaded Neuro-dynamics in Subjects With Thoracic Outlet Syndrome
Thoracic Outlet Syndrome, Mechanically Loaded Neuro-dynamics
Not yet recruiting
Effect of Low-Power Laser Therapy on Pain and Functional Outcomes in Patients With Thoracic Outlet Syndrome
Thoracic Outlet Syndrome
RecruitingObservational study
Vascular Lab Resource (VLR) Biorepository
Cardiovascular Diseases, Metabolic Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IncobotulinumtoxinA 100 UNT in people with Thoracic Outlet Syndrome and Whiplash Injuries, run by King, David, MD 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 10 inclusion and 7 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 13 Sep 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 David B King, BSc, MD (902 425 7344, david.larkspur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain disability as assessed using the PDQ at Week 4. (time frame: week 4). 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 13 Sep 2022.