- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05536570
Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin.
Management of Functional Thoracic Outlet Syndrome (TOS - Whiplash) With IncobotulinumtoxinA Injections
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: David B King, BSc, MD
- Telefonnummer: 902 425 7344
- E-mail: david.larkspur@gmail.com
Undersøgelse Kontakt Backup
- Navn: Debbie Cavicchi, BA
- Telefonnummer: 902 425 7344
- E-mail: dking@davidbking.ca
Studiesteder
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3P 1M3
- Private Office
-
Kontakt:
- David B King, BSc, MD
- Telefonnummer: 902 425 7344
- E-mail: david.larkspur@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
• 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;
- 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.
Exclusion Criteria:
• 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in pain disability as assessed using the PDQ at Week 4.
Tidsramme: 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 |
week 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Elevation
Tidsramme: week 4
|
Change from baseline in shoulder elevation as assessed by measurement on photograph (clavicular angle) at Weeks 4, 12 and 16;
|
week 4
|
|
Grip Strength
Tidsramme: Week 4
|
3. Change from baseline in grip strength as assessed using a dynamometer at Weeks 4, 12 and 16;
|
Week 4
|
|
Pinch Test
Tidsramme: WFeek 4
|
4. Change from baseline in fine motor test (pinch test) at Weeks 4, 12 and 16;
|
WFeek 4
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i nervesystemet
- Sår og skader
- Sygdom
- Neuromuskulære sygdomme
- Sygdomme i det perifere nervesystem
- Nervekompressionssyndromer
- Nakkeskader
- Syndrom
- Piskesmældsskader
- Thoracic Outlet Syndrome
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylcholin-frigivelseshæmmere
- Neuromuskulære midler
- incobotulinumtoxinA
Andre undersøgelses-id-numre
- EMSI-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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